Neoplasms
Conditions
Keywords
GSK3326595, Solid tumor, Non-Hodgkin's lymphoma (NHL), Urinary tract cancer, Dose escalation, Adenoid cystic carcinoma (ACC), Non small-cell lung cancer (NSCLC), Squamous cell carcinoma of the head and neck (HNSCC), Melanoma
Brief summary
This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-Hodgkin's lymphoma (NHL).
Interventions
DRUGGSK3326595
GSK3326595 will be administered with and without food, in tablet and capsule formulation.
DRUGPembrolizumab
Pembrolizumab will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open label study.
Intervention model description
This will be a three-part study where Part 1 is dose escalation, including assessment of Food Effect and Relative Bioavailability, Part 2 is disease specific expansion cohorts to better characterize the clinical activity and safety profile of GSK3326595 and Part 3 is dose determination of GSK3326595 in combination with pembrolizumab.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females greater than or equal to (\>=)18 years of age (at the time consent is obtained) * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2 * Diagnosis of non-resectable or metastatic solid malignancy (as defined in the protocol) or NHL * Presence of evaluable disease * Adequate organ function (as defined in the protocol) * Reproductive criteria (as defined in the protocol).
Exclusion criteria
* Malignancy attributed to prior solid organ transplant * Leptomeningeal disease, spinal cord compression, or brain metastases that require immediate central nervous system (CNS)-specific treatment in the opinion of the Investigator (for example \[e.g.\], for symptomatic disease) * History of a second malignancy, excluding non-melanoma skin cell cancer within the last three years * Evidence of severe or uncontrolled systemic diseases, or serious and/or pre-existing medical or other condition that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator * Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels. * Select cardiac abnormalities (as defined in the protocol) * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. * History of optic nerve neuropathy or neuritis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 30 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary). |
| Part 1: Number of Participants Withdrawn Due to AEs | Up to 30 months | The data for number of participants withdrawn due to AEs have been presented. |
| Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 21 days | DLT is considered to be clinically relevant AE by investigator if it met at least one of the criteria: Grade(G)3 neutropenia for \>=5 days/G4 neutropenia of any duration, G3 or greater febrile neutropenia, G4 or greater anemia of any duration and thrombocytopenia, or G3 thrombocytopenia with bleeding, Alanine aminotransferase (ALT) \>3x upper limit of normal (ULN)+bilirubin, \>=2xULN or ALT between 3-5 X ULN with bilirubin \< 2Xuln but with hepatitis symptoms/rash, G3 nausea/vomiting/diarrhea that does not improve within 72 hour, G4 or greater nausea/vomiting/diarrhea, G3 or greater hypertension, G3 or greater clinically significant non-hematologic toxicity per National Cancer Institute -- Common Terminology Criteria for Adverse Events (NCICTCAE), Inability to receive at least 80% of scheduled doses in the DLT observation period due to toxicity, G2 or higher toxicity that occurs beyond 21 days which in the judgment of the investigator and GSK Medical Monitor was considered to be a DLT. |
| Part 1: Number of Participants With Dose Modifications of GSK3326595 | Up to 30 months | The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 have been presented. |
| Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to 30 months | Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to 30 months | Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Baseline (Day 1) and up to 30 months | Blood samples were collected for evaluation of coagulation parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v4.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Baseline (Day 1) and up to 30 months | Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with no change or change to negative and change to positive have been presented. |
| Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline (Day 1) and up to week 132 | Urine samples were collected from participants to assess urine pH levels. |
| Part 1: Changes From Baseline in Urine Specific Gravity | Baseline (Day 1) and up to week 132 | Urine samples were collected from participants to assess urine specific gravity. |
| Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Baseline (Day 1) and up to 30 months | The abnormal vital sign ranges are: Heart Rate:- Low (\<60 beats per minute (bpm)), Normal (\>=60 bpm to \<=100 bpm), High (\>100 bpm); Temperature:- Low (\<=35 degree Celsius (°C)), Normal (\>35 °C and \<38 °C), High (\>=38 °C); Systolic Blood Pressure:- Low (\<90 millimeter of mercury (mmHg)), Normal (\>=90 mmHg to \<120 mmHg), High (\>=120 mmHg); Diastolic Blood Pressure:- Low (\<60 mmHg), Normal (\>=60 mmHg to \<80 mmHg), High (\>=80 mmHg). Participants were counted in the worst-case category and their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Part 3: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 10 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or was a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the MedDRA dictionary. |
| Part 3: Number of Participants Withdrawn Due to AEs | Up to 10 months | The data for number of participants withdrawn due to AEs have been presented. |
| Part 3: Number of Participants With Dose Modifications of GSK3326595 and Pembrolizumab | Up to 10 months | The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 and pembrolizumab have been presented. |
| Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to 10 months | Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. |
| Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to 10 months | Blood samples were collected for evaluation of hematology parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. |
| Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Baseline (Day 1) and up to 10 months | Blood samples were collected for evaluation of coagulation parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. |
| Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Baseline (Day 1) and up to 10 months | Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with no change or change to negative and change to positive values have been presented. |
| Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline (Day 1) and up to Week 42 | Urine samples were collected from participants to assess urine pH levels. |
| Part 3: Changes From Baseline in Urine Specific Gravity | Baseline (Day 1) and up to Week 42 | Urine samples were collected from participants to assess urine specific gravity. |
| Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Baseline (Day 1) and up to 10 months | The abnormal vital sign ranges are: Heart Rate:- Low \[\<60 bpm\], Normal (\>=60 bpm to \<=100 bpm), High (\>100 bpm); Temperature:- Low (\<=35 C), Normal (\>35 C and \<38 C), High (\>=38 C); Systolic Blood Pressure:- Low (\<90 mmHg), Normal (\>=90 mmHg to \<120 mmHg), High (\>=120 mmHg); Diastolic Blood Pressure:- Low (\<60 mmHg), Normal (\>=60 mmHg to \<80 mmHg), High (\>=80 mmHg). Participants were counted in the maximum worst case increase category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 3: Oral Clearance (CL/F) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Accumulation Ratio (AR) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 1 and Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 15 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595 |
| Part 3: Accumulation Ratio (AR) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595 |
| Part 1: Time Invariance (TI) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 1 and Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 15 | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. Time invariance was calculated as AUC(0-tau) at Day 15 divided by AUC(0-infinity) at Day 1 for GSK3326595. |
| Part 3: Time Invariance (TI) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. |
| Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | Up to 30 months | ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) per RECIST version 1.1. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm. |
| Part 2: Overall Response Rate (ORR) (Non-glioblastoma Multiforme [GBM] Cohorts) | Up to 42 months | Overall response rate (ORR) was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response (CR) was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). |
| Part 2: Six-month Progression Free Survival (PFS) Rate (GBM Cohort) | At month 6 | Six-month progression free survival (PFS) rate was defined as the percentage of participants free from radiographic progression per Response Assessment in Neuro-Oncology (RANO) criteria, or death due to any cause, for six months after starting GSK3326595. The RANO criteria were used to ascertain response (Wen, 2010). |
| Part 2: Duration of Response (DOR) (ACC Tablet Cohort) | Up to 42 months | Duration of response (DOR) was defined as time from first evidence of response (CR or PR per RECIST 1.1) to earlier date of disease progression or death due to any cause, as determined by Investigator assessment. |
| Part 3: ORR Based on Immune-based RECIST (iRECIST) Criteria | Up to 10 months | ORR was defined as the percentage of participants with irCR or irPR per irRECIST. irCR is defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). irPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. |
| Part 2: ORR (GBM Cohort) Based on Response Assessment Neuro-Oncology (RANO) Working Group Criteria | Up to 42 months | ORR was defined as the percentage of participants with a CR or PR, confirmed no less than 4 weeks based on the RANO criteria. CR was defined as complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks, stable or improved non-enhancing (T2/FLAIR) lesions, no new lesions, participants must be off corticosteroids (or on physiologic replacement doses only), and clinically stable or improved. PR was defined as at least 50% decrease compared to Baseline in the size of all measurable enhancing lesions sustained for at least 4 weeks, no progression of non-measurable disease or any new lesions, stable of lower dose of corticosteroids than Baseline dose, and stable or improved non-enhancing (T2/FLAIR) lesions. |
| Part 2: ORR (Non-Hodgkin's Lymphoma (NHL) Cohorts) Based on Lugano Criteria | Up to 42 months | ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Lugano Criteria for Non-Hodgkin's lymphoma cohorts. |
| Part 2: Overall Survival (OS) (ACC Tablet Cohort) | Up to 42 months | Overall survival (OS) was defined as time from first dose until death from any cause in ACC participants who are systemic-treatment naïve. |
| Part 2: Progression-free Survival | Up to 42 months | PFS was defined as time from first dose until radiographic progression per standard criteria or death due to any cause, whichever is earlier. |
| RP2D Phase: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to maximum 42 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or was associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the MedDRA dictionary. |
| RP2D Phase: Number of Participants Withdrawn Due to AEs | Up to maximum 42 months | The data for number of participants withdrawn due to AEs have been presented. |
| RP2D Phase: Number of Participants With Dose Modifications of GSK3326595 | Up to maximum 42 months | The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 have been presented. |
| RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to maximum 42 months | Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to maximum 42 months | Blood samples were collected for evaluation of hematology parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Baseline (Day 1) and up to maximum 42 months | Blood samples were collected for evaluation of coagulation parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 42 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or was associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the MedDRA dictionary. |
| RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline (Day 1) and up to Week 184 | Urine samples were collected from participants to assess urine pH levels. |
| RP2D Phase: Changes From Baseline in Urine Specific Gravity | Baseline (Day 1) and up to Week 184 | Urine samples were collected from participants to assess urine specific gravity. |
| RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Baseline (Day 1) and up to maximum 42 months | Vital signs were measured. The abnormal vital sign ranges are: Heart Rate:- Low \[\<60 beats per minute (bpm)\], Normal (\>=60 bpm to \<=100 bpm), High (\>100 bpm); Temperature:- Low (\<=35 C), Normal (\>35 C and \<38 C), High (\>=38 C); Systolic Blood Pressure:- Low (\<90 mmHg), Normal (\>=90 mmHg to \<120 mmHg), High (\>=120 mmHg); Diastolic Blood Pressure:- Low (\<60 mmHg), Normal (\>=60 mmHg to \<80 mmHg), High (\>=80 mmHg). Participants were counted in the worst-case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Baseline (Day 1) and up to maximum 42 months | Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v4.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. |
| Part 2: Number of Participants Withdrawn Due to AEs | Up to 42 months | The data for number of participants withdrawn due to AEs have been presented. |
| Part 2: Number of Participants With Dose Modifications of GSK3326595 | Up to 42 months | The number of participants who had any dose modifications (interruptions and reductions) of GSK3326595 have been presented. |
| Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to 42 months | Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to 42 months | Blood samples were collected for evaluation of hematology parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high values' have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Baseline (Day 1) and up to 42 months | Blood samples were collected for evaluation of coagulation parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Baseline (Day 1) and up to 42 months | Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. |
| Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline (Day 1) and up to week 184 | Urine samples were collected from participants to assess urine pH levels. |
| Part 2: Changes From Baseline in Urine Specific Gravity | Baseline (Day 1) and up to week 184 | Urine samples were collected from participants to assess urine specific gravity. |
| Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Baseline (Day 1) and up to 42 months | The abnormal vital sign ranges are: Heart Rate:- Low (\<60 beats per minute (bpm)), Normal (\>=60 bpm to \<=100 bpm), High (\>100 bpm); Temperature:- Low (\<=35 degree Celsius (C)), Normal (\>35 C and \<38 C), High (\>=38 C); Systolic Blood Pressure:- Low (\<90 millimeter of mercury (mmHg)), Normal (\>=90 mmHg to \<120 mmHg), High (\>=120 mmHg); Diastolic Blood Pressure:- Low (\<60 mmHg), Normal (\>=60 mmHg to \<80 mmHg), High (\>=80 mmHg). Participants were counted in the worst-case category and their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours (h) post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15 | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. |
| Part 3: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. |
| Part 3: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. |
| Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 h post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15 | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. |
| Part 3: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. |
| Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 h post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15 | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. |
| Part 3: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 h post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15 | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. |
| Part 3: Terminal Phase Half-life (t1/2) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Oral Clearance (CL/F) of GSK3326595 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose | Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. |
Countries
Canada, France, Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) Participant with relapsed and/or refractory solid tumors received 12.5 mg GSK3326595 capsules orally once a day until the maximally tolerated dose (MTD) was reached. | 1 |
| Part 1: GSK3326595 25mg QD Participant with relapsed and/or refractory solid tumors received 25 mg GSK3326595 capsules orally once a day until the MTD was reached. | 1 |
| Part 1: GSK3326595 50mg QD Participant with relapsed and/or refractory solid tumors received 50 mg GSK3326595 capsules orally once a day until the MTD was reached. | 1 |
| Part 1: GSK3326595 100mg QD Participant with relapsed and/or refractory solid tumors received 100 mg GSK3326595 capsules orally once a day until the MTD was reached. | 1 |
| Part 1: GSK3326595 200mg QD Participant with relapsed and/or refractory solid tumors received 200 mg GSK3326595 capsules orally once a day until the MTD was reached. | 8 |
| Part 1: GSK3326595 300mg QD Participant with relapsed and/or refractory solid tumors received 300 mg GSK3326595 capsules orally once a day until the MTD was reached. | 3 |
| Part 1: GSK3326595 400mg QD Participant with relapsed and/or refractory solid tumors received 400 mg GSK3326595 capsules orally once a day. | 19 |
| Part 1: GSK3326595 600mg QD Participant with relapsed and/or refractory solid tumors received 600 mg GSK3326595 capsules orally once a day. | 3 |
| Part 1: GSK3326595 50mg Twice Daily (BID) Participant with relapsed and/or refractory solid tumors received 50 mg GSK3326595 capsules twice a day. | 1 |
| Part 1: GSK3326595 100mg BID Participant with relapsed and/or refractory solid tumors received 100 mg GSK3326595 capsules twice a day. | 7 |
| Part 1: GSK3326595 150mg BID Participant with relapsed and/or refractory solid tumors received 150 mg GSK3326595 capsules twice a day. | 6 |
| Part 1: GSK3326595 200mg BID Participant with relapsed and/or refractory solid tumors received 200 mg GSK3326595 capsules twice a day. | 3 |
| Part 1: GSK3326595 300mg QD (Food Effect) Participant with relapsed and/or refractory solid tumors received 300 mg GSK3326595 once a day (QD) tablet/capsule under fasting conditions, with no food or antacids for 1 h before and 2 h after each dose OR under fed condition with recommended high fat, high calorie breakfast 30 minutes prior to administration of GSK3326595. | 15 |
| Part 2: GSK3326595 400mg (TNBC) Participant with triple-negative breast cancer (TNBC) received 400 mg GSK3326595 capsules orally once a day. | 22 |
| Part 2: GSK3326595 400mg (mTCC) Participant with metastatic transitional cell carcinoma of the urinary system (mTCC) received 400 mg GSK3326595 capsules orally once a day. | 16 |
| Part 2: GSK3326595 400mg (GBM) Participant with Grade IV anaplastic astrocytoma (glioblastoma multiforme \[GBM\]) received 400 mg GSK3326595 capsules orally once a day. | 29 |
| Part 2: GSK3326595 400mg (ER+BC) Participant with hormone receptor-positive adenocarcinoma of the breast (ER+BC) received 400 mg GSK3326595 capsules orally once a day. | 37 |
| Part 2: GSK3326595 400mg (HPV+) Participant with human papillomavirus (HPV)-positive solid tumors received 400 mg GSK3326595 capsules orally once a day. | 28 |
| Part 2: GSK3326595 400mg (ACC) Participant with adenoid cystic carcinoma (ACC) received 400 mg GSK3326595 capsules orally once a day. | 34 |
| Part 2: GSK3326595 300mg (ACC) Participant with ACC received 300 mg GSK3326595 tablets orally once a day. | 16 |
| Part 2: GSK3326595 400mg (NHL P53 Mutant) Participant with non-Hodgkin's lymphoma (NHL) P53 Mutant received 400 mg GSK3326595 capsules orally once a day. | 6 |
| Part 2: GSK3326595 300mg (NHL P53 Mutant) Participant with NHL P53 Mutant received 300 mg GSK3326595 capsules orally once a day. | 2 |
| Part 2: GSK3326595 400mg (NHL P53 Wild Type) Participant with NHL P53 Wild Type received 400 mg GSK3326595 capsules orally once a day. | 8 |
| Part 2: GSK3326595 300mg (NHL P53 Wild Type) Participant with NHL P53 Wild Type received 300 mg GSK3326595 capsules orally once a day. | 2 |
| Part 2: GSK3326595 400mg (NHL P53 Unknown) Participant with NHL P53 Unknown received 400 mg GSK3326595 capsules orally once a day. | 11 |
| Part 2: GSK3326595 300mg (NSCLC) Participant with non-small cell lung cancer (NSCLC) received 300 mg GSK3326595 capsules orally once a day. | 7 |
| Part 3: GSK3326595 100mg + Pembrolizumab 200mg Participant with NSCLC, mTCC, melanoma, and HNSCC received 100 mg GSK3326595 capsules in combination with 200 mg Pembrolizumab orally once a day. | 10 |
| Total | 297 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 | FG026 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1- Dose Escalation Phase | Investigator discretion | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1- Dose Escalation Phase | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1- Dose Escalation Phase | Other reasons | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1- Dose Escalation Phase | Site Terminated by Sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1- Dose Escalation Phase | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 2- Disease-specific Expansion Phase | Investigator discretion | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 3 | 3 | 3 | 1 | 3 | 5 | 1 | 1 | 2 | 1 | 3 | 4 | 0 |
| Part 2- Disease-specific Expansion Phase | Investigator site closed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Part 2- Disease-specific Expansion Phase | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Part 2- Disease-specific Expansion Phase | Other reasons | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 2- Disease-specific Expansion Phase | Site Terminated by Sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 2- Disease-specific Expansion Phase | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 2 | 1 | 0 | 7 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 3- Dose Determination Phase | Investigator discretion | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Part 3- Dose Determination Phase | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Part 2: GSK3326595 400mg (NHL P53 Wild Type) | Part 2: GSK3326595 300mg (NHL P53 Wild Type) | Part 2: GSK3326595 400mg (NHL P53 Unknown) | Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: GSK3326595 25mg QD | Part 1: GSK3326595 50mg QD | Part 1: GSK3326595 100mg QD | Part 1: GSK3326595 200mg QD | Part 1: GSK3326595 300mg QD | Part 1: GSK3326595 400mg QD | Part 1: GSK3326595 600mg QD | Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: GSK3326595 100mg BID | Part 1: GSK3326595 150mg BID | Part 1: GSK3326595 200mg BID | Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: GSK3326595 400mg (TNBC) | Part 2: GSK3326595 400mg (mTCC) | Part 2: GSK3326595 400mg (GBM) | Part 2: GSK3326595 400mg (ER+BC) | Part 2: GSK3326595 400mg (HPV+) | Part 2: GSK3326595 400mg (ACC) | Part 2: GSK3326595 300mg (ACC) | Part 2: GSK3326595 400mg (NHL P53 Mutant) | Part 2: GSK3326595 300mg (NHL P53 Mutant) | Part 2: GSK3326595 300mg (NSCLC) | Part 3: GSK3326595 100mg + Pembrolizumab 200mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 18 - 84 Years | 8 Participants | 2 Participants | 11 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 8 Participants | 3 Participants | 19 Participants | 3 Participants | 1 Participants | 7 Participants | 6 Participants | 3 Participants | 15 Participants | 22 Participants | 16 Participants | 29 Participants | 37 Participants | 28 Participants | 34 Participants | 16 Participants | 6 Participants | 2 Participants | 7 Participants | 10 Participants | 297 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Others | 8 Participants | 2 Participants | 11 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 8 Participants | 3 Participants | 19 Participants | 3 Participants | 1 Participants | 7 Participants | 6 Participants | 3 Participants | 15 Participants | 22 Participants | 16 Participants | 28 Participants | 37 Participants | 28 Participants | 34 Participants | 15 Participants | 6 Participants | 2 Participants | 7 Participants | 9 Participants | 294 Participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 5 Participants | 2 Participants | 8 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 7 Participants | 22 Participants | 5 Participants | 6 Participants | 37 Participants | 23 Participants | 16 Participants | 11 Participants | 2 Participants | 1 Participants | 2 Participants | 4 Participants | 167 Participants |
| Sex: Female, Male Male | 5 Participants | 1 Participants | 9 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 11 Participants | 1 Participants | 0 Participants | 5 Participants | 5 Participants | 1 Participants | 8 Participants | 0 Participants | 11 Participants | 23 Participants | 0 Participants | 5 Participants | 18 Participants | 5 Participants | 4 Participants | 1 Participants | 5 Participants | 6 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 1 | 1 / 1 | 1 / 1 | 0 / 1 | 7 / 8 | 3 / 3 | 13 / 19 | 3 / 3 | 1 / 1 | 6 / 7 | 6 / 6 | 3 / 3 | 8 / 15 | 16 / 22 | 10 / 16 | 22 / 29 | 31 / 37 | 25 / 28 | 20 / 34 | 2 / 16 | 4 / 6 | 1 / 2 | 5 / 8 | 1 / 2 | 7 / 11 | 3 / 7 | 6 / 10 |
| other Total, other adverse events | 1 / 1 | 1 / 1 | 1 / 1 | 1 / 1 | 7 / 8 | 3 / 3 | 19 / 19 | 3 / 3 | 1 / 1 | 7 / 7 | 6 / 6 | 3 / 3 | 15 / 15 | 22 / 22 | 16 / 16 | 27 / 29 | 37 / 37 | 28 / 28 | 34 / 34 | 16 / 16 | 6 / 6 | 2 / 2 | 8 / 8 | 2 / 2 | 11 / 11 | 7 / 7 | 9 / 10 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 4 / 8 | 1 / 3 | 10 / 19 | 1 / 3 | 0 / 1 | 2 / 7 | 3 / 6 | 3 / 3 | 6 / 15 | 13 / 22 | 7 / 16 | 15 / 29 | 10 / 37 | 13 / 28 | 15 / 34 | 5 / 16 | 4 / 6 | 2 / 2 | 4 / 8 | 0 / 2 | 4 / 11 | 0 / 7 | 5 / 10 |
Outcome results
Primary
Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH)
Urine samples were collected from participants to assess urine pH levels.
Time frame: Baseline (Day 1) and up to week 132
Population: All treated population. Only those participants with data available at specified timepoint have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 7.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | -1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 1.061 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 36 | -1.00 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 44 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | -1.50 Potential of Hydrogen (pH) | Standard Deviation 1.414 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.20 Potential of Hydrogen (pH) | Standard Deviation 0.447 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | 0.17 Potential of Hydrogen (pH) | Standard Deviation 0.516 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.00 Potential of Hydrogen (pH) | Standard Deviation 0.886 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.5 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 52 | -0.50 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | -0.75 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.21 Potential of Hydrogen (pH) | Standard Deviation 0.488 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -1.17 Potential of Hydrogen (pH) | Standard Deviation 1.155 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | -0.75 Potential of Hydrogen (pH) | Standard Deviation 1.768 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | 0.75 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | -1.00 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 28 | -1.25 Potential of Hydrogen (pH) | Standard Deviation 1.061 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.17 Potential of Hydrogen (pH) | Standard Deviation 0.577 |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.75 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -0.75 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | -0.17 Potential of Hydrogen (pH) | Standard Deviation 0.289 |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.17 Potential of Hydrogen (pH) | Standard Deviation 0.289 |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 88 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 80 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 76 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.11 Potential of Hydrogen (pH) | Standard Deviation 0.698 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | -0.11 Potential of Hydrogen (pH) | Standard Deviation 0.546 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | 0.14 Potential of Hydrogen (pH) | Standard Deviation 0.69 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.28 Potential of Hydrogen (pH) | Standard Deviation 0.548 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.548 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -0.19 Potential of Hydrogen (pH) | Standard Deviation 0.63 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 0.10 Potential of Hydrogen (pH) | Standard Deviation 0.418 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.43 Potential of Hydrogen (pH) | Standard Deviation 0.799 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 28 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.479 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.408 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 36 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.611 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | -0.17 Potential of Hydrogen (pH) | Standard Deviation 0.289 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 124 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 120 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 116 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 64 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 112 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 108 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 104 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 68 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 100 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 96 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 92 | -1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 72 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 84 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 44 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | -0.17 Potential of Hydrogen (pH) | Standard Deviation 0.289 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | -0.24 Potential of Hydrogen (pH) | Standard Deviation 0.731 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 52 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 0.5 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 56 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 132 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 128 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 60 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | 0.67 Potential of Hydrogen (pH) | Standard Deviation 1.041 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 36 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | 0.83 Potential of Hydrogen (pH) | Standard Deviation 0.764 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 28 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 1 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 1.061 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 1.414 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | 1.00 Potential of Hydrogen (pH) | Standard Deviation 1.414 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 0.75 Potential of Hydrogen (pH) | Standard Deviation 1.768 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | -0.50 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 1.00 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.67 Potential of Hydrogen (pH) | Standard Deviation 0.764 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 64 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | 0.38 Potential of Hydrogen (pH) | Standard Deviation 0.629 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 0.75 Potential of Hydrogen (pH) | Standard Deviation 0.645 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.07 Potential of Hydrogen (pH) | Standard Deviation 1.239 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 1.00 Potential of Hydrogen (pH) | Standard Deviation 1.414 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.29 Potential of Hydrogen (pH) | Standard Deviation 1.035 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 72 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | 0.33 Potential of Hydrogen (pH) | Standard Deviation 0.289 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 28 | 1.50 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.21 Potential of Hydrogen (pH) | Standard Deviation 0.488 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.79 Potential of Hydrogen (pH) | Standard Deviation 1.075 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 36 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | 1.00 Potential of Hydrogen (pH) | Standard Deviation 1.414 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 44 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 68 | 1.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | -0.29 Potential of Hydrogen (pH) | Standard Deviation 0.859 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 52 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 56 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 60 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -0.20 Potential of Hydrogen (pH) | Standard Deviation 0.274 |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | 0.08 Potential of Hydrogen (pH) | Standard Deviation 0.492 |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.10 Potential of Hydrogen (pH) | Standard Deviation 0.548 |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | 0.10 Potential of Hydrogen (pH) | Standard Deviation 0.548 |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.08 Potential of Hydrogen (pH) | Standard Deviation 0.492 |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.75 Potential of Hydrogen (pH) | Standard Deviation 0.524 |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 56 | 1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 28 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 44 | 1.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | 1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 88 | 1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 104 | 1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 76 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 80 | 1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 84 | 1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 96 | 1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 1.061 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 72 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 36 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 68 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 52 | 1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 92 | 1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 108 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.17 Potential of Hydrogen (pH) | Standard Deviation 0.764 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 64 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 112 | 1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 100 | 1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | 0.33 Potential of Hydrogen (pH) | Standard Deviation 1.258 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | 0.75 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 60 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 108 | -1.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 112 | -0.50 Potential of Hydrogen (pH) | Standard Deviation 0.866 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 60 | -1.00 Potential of Hydrogen (pH) | Standard Deviation 0.5 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 116 | -0.75 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 104 | -0.83 Potential of Hydrogen (pH) | Standard Deviation 0.289 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 120 | -0.33 Potential of Hydrogen (pH) | Standard Deviation 0.289 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 124 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 56 | -0.83 Potential of Hydrogen (pH) | Standard Deviation 0.289 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 128 | -0.33 Potential of Hydrogen (pH) | Standard Deviation 0.764 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.03 Potential of Hydrogen (pH) | Standard Deviation 0.516 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 52 | -0.30 Potential of Hydrogen (pH) | Standard Deviation 0.274 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 64 | -0.33 Potential of Hydrogen (pH) | Standard Deviation 0.764 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | -0.50 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 100 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 44 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.854 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | 0.08 Potential of Hydrogen (pH) | Standard Deviation 1.021 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.63 Potential of Hydrogen (pH) | Standard Deviation 0.834 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.03 Potential of Hydrogen (pH) | Standard Deviation 0.719 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 96 | -0.33 Potential of Hydrogen (pH) | Standard Deviation 0.289 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | -0.20 Potential of Hydrogen (pH) | Standard Deviation 0.758 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 36 | -0.63 Potential of Hydrogen (pH) | Standard Deviation 0.479 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 92 | -0.75 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.10 Potential of Hydrogen (pH) | Standard Deviation 0.849 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | 0.10 Potential of Hydrogen (pH) | Standard Deviation 1.194 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 68 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.866 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 28 | -0.40 Potential of Hydrogen (pH) | Standard Deviation 0.418 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 88 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 1.061 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | -0.60 Potential of Hydrogen (pH) | Standard Deviation 0.418 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 84 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.04 Potential of Hydrogen (pH) | Standard Deviation 0.865 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.854 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 76 | -0.75 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.25 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 80 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.866 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 72 | -0.33 Potential of Hydrogen (pH) | Standard Deviation 0.764 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 0.44 Potential of Hydrogen (pH) | Standard Deviation 0.682 |
Primary
Part 1: Changes From Baseline in Urine Specific Gravity
Urine samples were collected from participants to assess urine specific gravity.
Time frame: Baseline (Day 1) and up to week 132
Population: All treated population. Only those participants with data available at specified timepoint have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | -0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | -0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | -0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | -0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | -0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline | 1.03 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | — |
| Part 1: GSK3326595 50mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.01 Ratio | — |
| Part 1: GSK3326595 50mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline | 1.01 Ratio | — |
| Part 1: GSK3326595 50mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | — |
| Part 1: GSK3326595 50mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.01 Ratio | — |
| Part 1: GSK3326595 50mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.01 Ratio | — |
| Part 1: GSK3326595 100mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.01 Ratio | — |
| Part 1: GSK3326595 100mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | — |
| Part 1: GSK3326595 100mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.01 Ratio | — |
| Part 1: GSK3326595 100mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.01 Ratio | — |
| Part 1: GSK3326595 100mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | — |
| Part 1: GSK3326595 100mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | — |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 36 | -0.01 Ratio | Standard Deviation 0.014 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 28 | 0.00 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.00 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 44 | 0.00 Ratio | Standard Deviation 0.014 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | 0.00 Ratio | Standard Deviation 0.014 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 52 | 0.00 Ratio | Standard Deviation 0.018 |
| Part 1: GSK3326595 200mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | -0.01 Ratio | Standard Deviation 0.014 |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | -0.01 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | -0.01 Ratio | — |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | -0.01 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | -0.01 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | -0.02 Ratio | — |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 300mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 124 | -0.01 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 44 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 120 | -0.01 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 116 | -0.01 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 112 | -0.01 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | 0.00 Ratio | Standard Deviation 0.012 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 108 | 0.00 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 104 | -0.01 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 100 | -0.01 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 96 | -0.01 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 92 | 0.00 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 88 | -0.01 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 84 | 0.00 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 72 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 80 | -0.01 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 68 | -0.01 Ratio | Standard Deviation 0 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 64 | -0.01 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 132 | 0.00 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 36 | 0.01 Ratio | Standard Deviation 0.013 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 60 | -0.01 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 56 | -0.01 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 76 | -0.01 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 52 | 0.00 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 28 | 0.00 Ratio | Standard Deviation 0.012 |
| Part 1: GSK3326595 400mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 128 | -0.01 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | -0.01 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | 0.00 Ratio | Standard Deviation 0.002 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | -0.01 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 28 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.01 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.002 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 36 | 0.01 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 600mg QD | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline | 1.01 Ratio | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.01 Ratio | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.01 Ratio | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.01 Ratio | — |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 60 | 0.01 Ratio | — |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.012 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | -0.01 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 28 | 0.00 Ratio | Standard Deviation 0.015 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0.014 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 36 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | 0.00 Ratio | Standard Deviation 0.015 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 44 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 52 | 0.01 Ratio | — |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 56 | 0.01 Ratio | — |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 64 | 0.01 Ratio | — |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 68 | 0.01 Ratio | — |
| Part 1: GSK3326595 100mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 72 | 0.01 Ratio | — |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline | 1.03 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.00 Ratio | — |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | -0.01 Ratio | — |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | — |
| Part 1: GSK3326595 150mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | 0.00 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 76 | -0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | -0.01 Ratio | Standard Deviation 0 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 44 | -0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | -0.01 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | -0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 52 | -0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | -0.01 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 56 | 0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 60 | -0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | -0.01 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 64 | -0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 68 | -0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 72 | -0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | -0.01 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 80 | 0.00 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 84 | 0.00 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 88 | 0.00 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 92 | 0.00 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 96 | 0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 100 | 0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 104 | 0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 108 | -0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 112 | -0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 28 | -0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 36 | 0.01 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 200mg BID | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | -0.01 Ratio | Standard Deviation 0 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 120 | 0.01 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | 0.00 Ratio | Standard Deviation 0.003 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 80 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 44 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 28 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 84 | 0.00 Ratio | — |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 108 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 88 | 0.00 Ratio | Standard Deviation 0.003 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 92 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 116 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 76 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 52 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | 0.00 Ratio | Standard Deviation 0.003 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 124 | 0.01 Ratio | — |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0.002 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 56 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 96 | 0.00 Ratio | Standard Deviation 0.003 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 60 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 112 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 100 | 0.00 Ratio | Standard Deviation 0.001 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 64 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 128 | 0.01 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0.003 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 68 | 0.00 Ratio | Standard Deviation 0.003 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 36 | 0.00 Ratio | Standard Deviation 0.002 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 72 | 0.00 Ratio | Standard Deviation 0.002 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Changes From Baseline in Urine Specific Gravity | CFB to Week 104 | -0.01 Ratio | Standard Deviation 0.008 |
Primary
Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Time frame: Up to 30 months
Population: All treated population included all participants who received at least one dose of GSK3326595.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 7 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 19 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 10 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 7 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 6 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 6 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 15 Participants |
Primary
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT is considered to be clinically relevant AE by investigator if it met at least one of the criteria: Grade(G)3 neutropenia for \>=5 days/G4 neutropenia of any duration, G3 or greater febrile neutropenia, G4 or greater anemia of any duration and thrombocytopenia, or G3 thrombocytopenia with bleeding, Alanine aminotransferase (ALT) \>3x upper limit of normal (ULN)+bilirubin, \>=2xULN or ALT between 3-5 X ULN with bilirubin \< 2Xuln but with hepatitis symptoms/rash, G3 nausea/vomiting/diarrhea that does not improve within 72 hour, G4 or greater nausea/vomiting/diarrhea, G3 or greater hypertension, G3 or greater clinically significant non-hematologic toxicity per National Cancer Institute -- Common Terminology Criteria for Adverse Events (NCICTCAE), Inability to receive at least 80% of scheduled doses in the DLT observation period due to toxicity, G2 or higher toxicity that occurs beyond 21 days which in the judgment of the investigator and GSK Medical Monitor was considered to be a DLT.
Time frame: Up to 21 days
Population: All treated population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
Primary
Part 1: Number of Participants With Dose Modifications of GSK3326595
The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 have been presented.
Time frame: Up to 30 months
Population: All treated population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 18 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 16 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 4 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 14 Participants |
Primary
Part 1: Number of Participants Withdrawn Due to AEs
The data for number of participants withdrawn due to AEs have been presented.
Time frame: Up to 30 months
Population: All treated population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants Withdrawn Due to AEs | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants Withdrawn Due to AEs | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants Withdrawn Due to AEs | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants Withdrawn Due to AEs | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants Withdrawn Due to AEs | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants Withdrawn Due to AEs | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants Withdrawn Due to AEs | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants Withdrawn Due to AEs | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants Withdrawn Due to AEs | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants Withdrawn Due to AEs | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants Withdrawn Due to AEs | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants Withdrawn Due to AEs | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants Withdrawn Due to AEs | 1 Participants |
Primary
Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs
The abnormal vital sign ranges are: Heart Rate:- Low (\<60 beats per minute (bpm)), Normal (\>=60 bpm to \<=100 bpm), High (\>100 bpm); Temperature:- Low (\<=35 degree Celsius (°C)), Normal (\>35 °C and \<38 °C), High (\>=38 °C); Systolic Blood Pressure:- Low (\<90 millimeter of mercury (mmHg)), Normal (\>=90 mmHg to \<120 mmHg), High (\>=120 mmHg); Diastolic Blood Pressure:- Low (\<60 mmHg), Normal (\>=60 mmHg to \<80 mmHg), High (\>=80 mmHg). Participants were counted in the worst-case category and their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Baseline (Day 1) and up to 30 months
Population: All treated population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 8 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 5 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 2 Participants |
Primary
Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Baseline (Day 1) and up to 30 months
Population: All treated population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 12 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 10 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 4 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 12 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 12 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 8 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 4 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 5 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 5 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 4 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 6 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 5 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 6 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 13 Participants |
Primary
Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters
Blood samples were collected for evaluation of coagulation parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v4.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Baseline (Day 1) and up to 30 months
Population: All treated population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 10 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 7 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 4 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 10 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 8 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
Primary
Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters
Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Baseline (Day 1) and up to 30 months
Population: All treated population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 12 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 5 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 14 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 11 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 5 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 8 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 13 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 5 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 4 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 12 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 13 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 6 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 6 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 8 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 5 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils/ Leukocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 8 Participants |
Primary
Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters
Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with no change or change to negative and change to positive have been presented.
Time frame: Baseline (Day 1) and up to 30 months
Population: All treated population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 7 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 8 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 18 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 8 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 11 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 11 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 12 Participants |
| Part 1: GSK3326595 400mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 7 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 7 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 4 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 5 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 4 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 8 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 5 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 10 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 5 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 10 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 11 Participants |
Primary
Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH)
Urine samples were collected from participants to assess urine pH levels.
Time frame: Baseline (Day 1) and up to Week 42
Population: All treated population. Only those participants with data available at specified timepoint have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.60 Potential of Hydrogen (pH) | Standard Deviation 0.937 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 1 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | 0.38 Potential of Hydrogen (pH) | Standard Deviation 0.582 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.33 Potential of Hydrogen (pH) | Standard Deviation 0.75 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | 0.33 Potential of Hydrogen (pH) | Standard Deviation 0.5 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | Week 6 Day 1 | 0.31 Potential of Hydrogen (pH) | Standard Deviation 0.704 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 9 | 0.33 Potential of Hydrogen (pH) | Standard Deviation 0.577 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | 0.83 Potential of Hydrogen (pH) | Standard Deviation 0.764 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 15 | 0.67 Potential of Hydrogen (pH) | Standard Deviation 0.289 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 18 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 0.5 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 21 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 0.5 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 27 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 30 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 33 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 36 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 39 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 42 | 0.00 Potential of Hydrogen (pH) | — |
Primary
Part 3: Changes From Baseline in Urine Specific Gravity
Urine samples were collected from participants to assess urine specific gravity.
Time frame: Baseline (Day 1) and up to Week 42
Population: All treated population. Only those participants with data available at specified timepoint have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Day 1 | 0.00 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | -0.01 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | -0.01 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.001 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 9 | -0.01 Ratio | Standard Deviation 0.003 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | -0.01 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 15 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 18 | -0.01 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 21 | 0.00 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | -0.01 Ratio | Standard Deviation 0.001 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 27 | 0.00 Ratio | Standard Deviation 0.016 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 30 | 0.00 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 33 | 0.00 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 36 | 0.00 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 39 | 0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Changes From Baseline in Urine Specific Gravity | CFB to Week 42 | 0.01 Ratio | — |
Primary
Part 3: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or was a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs is presented. AEs were coded using the MedDRA dictionary.
Time frame: Up to 10 months
Population: All treated population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 9 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 5 Participants |
Primary
Part 3: Number of Participants With Dose Modifications of GSK3326595 and Pembrolizumab
The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 and pembrolizumab have been presented.
Time frame: Up to 10 months
Population: All treated population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Dose Modifications of GSK3326595 and Pembrolizumab | Dose interruptions of GSK3326595 | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Dose Modifications of GSK3326595 and Pembrolizumab | Dose reductions of GSK3326595 | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Dose Modifications of GSK3326595 and Pembrolizumab | Dose Interruptions of Pembrolizumab | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Dose Modifications of GSK3326595 and Pembrolizumab | Dose reductions of Pembrolizumab | 0 Participants |
Primary
Part 3: Number of Participants Withdrawn Due to AEs
The data for number of participants withdrawn due to AEs have been presented.
Time frame: Up to 10 months
Population: All treated population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants Withdrawn Due to AEs | 1 Participants |
Primary
Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs
The abnormal vital sign ranges are: Heart Rate:- Low \[\<60 bpm\], Normal (\>=60 bpm to \<=100 bpm), High (\>100 bpm); Temperature:- Low (\<=35 C), Normal (\>35 C and \<38 C), High (\>=38 C); Systolic Blood Pressure:- Low (\<90 mmHg), Normal (\>=90 mmHg to \<120 mmHg), High (\>=120 mmHg); Diastolic Blood Pressure:- Low (\<60 mmHg), Normal (\>=60 mmHg to \<80 mmHg), High (\>=80 mmHg). Participants were counted in the maximum worst case increase category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Baseline (Day 1) and up to 10 months
Population: All treated population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 4 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Maximum Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
Primary
Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented.
Time frame: Baseline (Day 1) and up to 10 months
Population: All treated population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 4 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 7 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 4 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 5 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 1 Participants |
Primary
Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters
Blood samples were collected for evaluation of coagulation parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented.
Time frame: Baseline (Day 1) and up to 10 months
Population: All treated population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 4 Participants |
Primary
Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters
Blood samples were collected for evaluation of hematology parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented.
Time frame: Baseline (Day 1) and up to 10 months
Population: All treated population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 5 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 3 Participants |
Primary
Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters
Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with no change or change to negative and change to positive values have been presented.
Time frame: Baseline (Day 1) and up to 10 months
Population: All treated population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 7 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 7 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 10 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
Secondary
Part 1: Accumulation Ratio (AR) of GSK3326595
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 1 and Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 15
Population: Pharmacokinetic (PK) population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3326595 25mg QD | Part 1: Accumulation Ratio (AR) of GSK3326595 | 0.840 Ratio | — |
| Part 1: GSK3326595 50mg QD | Part 1: Accumulation Ratio (AR) of GSK3326595 | 0.719 Ratio | — |
| Part 1: GSK3326595 100mg QD | Part 1: Accumulation Ratio (AR) of GSK3326595 | 1.20 Ratio | — |
| Part 1: GSK3326595 200mg QD | Part 1: Accumulation Ratio (AR) of GSK3326595 | 1.34 Ratio | Geometric Coefficient of Variation 33.8 |
| Part 1: GSK3326595 300mg QD | Part 1: Accumulation Ratio (AR) of GSK3326595 | 1.11 Ratio | Geometric Coefficient of Variation 8.37 |
| Part 1: GSK3326595 400mg QD | Part 1: Accumulation Ratio (AR) of GSK3326595 | 1.34 Ratio | Geometric Coefficient of Variation 21.2 |
| Part 1: GSK3326595 600mg QD | Part 1: Accumulation Ratio (AR) of GSK3326595 | 1.60 Ratio | Geometric Coefficient of Variation 23.3 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Accumulation Ratio (AR) of GSK3326595 | 1.50 Ratio | — |
| Part 1: GSK3326595 100mg BID | Part 1: Accumulation Ratio (AR) of GSK3326595 | 1.23 Ratio | Geometric Coefficient of Variation 62.1 |
| Part 1: GSK3326595 150mg BID | Part 1: Accumulation Ratio (AR) of GSK3326595 | 2.31 Ratio | Geometric Coefficient of Variation 38.1 |
| Part 1: GSK3326595 200mg BID | Part 1: Accumulation Ratio (AR) of GSK3326595 | 1.43 Ratio | Geometric Coefficient of Variation 11.8 |
Secondary
Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose
Population: Pharmacokinetic (PK) population included all participants from the All Treated Population for whom a PK sample was obtained and analyzed. Only those participants with data available at specified time points have been analyzed. Data was not available for samples that were out of stability or lost in transit.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3326595 25mg QD | Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | 349 Hour*Nanogram/ millilitre (h*ng/mL) | — |
| Part 1: GSK3326595 50mg QD | Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | 926 Hour*Nanogram/ millilitre (h*ng/mL) | — |
| Part 1: GSK3326595 100mg QD | Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | 1710 Hour*Nanogram/ millilitre (h*ng/mL) | — |
| Part 1: GSK3326595 200mg QD | Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | 3240 Hour*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 25.3 |
| Part 1: GSK3326595 300mg QD | Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | 3800 Hour*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 27.2 |
| Part 1: GSK3326595 400mg QD | Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | 6760 Hour*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 32.2 |
| Part 1: GSK3326595 600mg QD | Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | 9610 Hour*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 27 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | 282 Hour*Nanogram/ millilitre (h*ng/mL) | — |
| Part 1: GSK3326595 100mg BID | Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | 916 Hour*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 42.9 |
| Part 1: GSK3326595 150mg BID | Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | 1260 Hour*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 47.9 |
| Part 1: GSK3326595 200mg BID | Part 1: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | 4250 Hour*Nanogram/ millilitre (h*ng/mL) | Geometric Coefficient of Variation 65.1 |
Secondary
Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 h post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15
Population: Pharmacokinetic (PK) population included all participants from the All Treated Population for whom a PK sample was obtained and analyzed. Only those participants with data available at specified time points have been analyzed. Data was not available for samples that were out of stability or lost in transit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3326595 25mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 1 | 249 h*ng/mL | — |
| Part 1: GSK3326595 25mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 15 | 215 h*ng/mL | — |
| Part 1: GSK3326595 50mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 1 | 858 h*ng/mL | — |
| Part 1: GSK3326595 50mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 15 | 600 h*ng/mL | — |
| Part 1: GSK3326595 100mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 1 | 1610 h*ng/mL | — |
| Part 1: GSK3326595 100mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 15 | 2040 h*ng/mL | — |
| Part 1: GSK3326595 200mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 1 | 3090 h*ng/mL | Geometric Coefficient of Variation 26.7 |
| Part 1: GSK3326595 200mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 15 | 4180 h*ng/mL | Geometric Coefficient of Variation 32.9 |
| Part 1: GSK3326595 300mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 1 | 3690 h*ng/mL | Geometric Coefficient of Variation 28.1 |
| Part 1: GSK3326595 300mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 15 | 4140 h*ng/mL | Geometric Coefficient of Variation 29 |
| Part 1: GSK3326595 400mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 15 | 7960 h*ng/mL | Geometric Coefficient of Variation 41.7 |
| Part 1: GSK3326595 400mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 1 | 6560 h*ng/mL | Geometric Coefficient of Variation 32.5 |
| Part 1: GSK3326595 600mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 15 | 12900 h*ng/mL | Geometric Coefficient of Variation 32.8 |
| Part 1: GSK3326595 600mg QD | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 1 | 9380 h*ng/mL | Geometric Coefficient of Variation 26.6 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 1 | 249 h*ng/mL | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 15 | 370 h*ng/mL | — |
| Part 1: GSK3326595 100mg BID | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 1 | 816 h*ng/mL | Geometric Coefficient of Variation 46 |
| Part 1: GSK3326595 100mg BID | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 15 | 965 h*ng/mL | Geometric Coefficient of Variation 43.7 |
| Part 1: GSK3326595 150mg BID | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 1 | 1100 h*ng/mL | Geometric Coefficient of Variation 54.6 |
| Part 1: GSK3326595 150mg BID | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 15 | 2360 h*ng/mL | Geometric Coefficient of Variation 52.2 |
| Part 1: GSK3326595 200mg BID | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 1 | 3950 h*ng/mL | Geometric Coefficient of Variation 63 |
| Part 1: GSK3326595 200mg BID | Part 1: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | Day 15 | 4040 h*ng/mL | Geometric Coefficient of Variation 0.58 |
Secondary
Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 h post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15
Population: Pharmacokinetic (PK) population included all participants from the All Treated Population for whom a PK sample was obtained and analyzed. Only those participants with data available at specified time points have been analyzed. Data was not available for samples that were out of stability or lost in transit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3326595 25mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 1 | 331 h*ng/mL | — |
| Part 1: GSK3326595 25mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 15 | 278 h*ng/mL | — |
| Part 1: GSK3326595 50mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 1 | 924 h*ng/mL | — |
| Part 1: GSK3326595 50mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 15 | 664 h*ng/mL | — |
| Part 1: GSK3326595 100mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 1 | 1710 h*ng/mL | — |
| Part 1: GSK3326595 100mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 15 | 2050 h*ng/mL | — |
| Part 1: GSK3326595 200mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 1 | 3120 h*ng/mL | Geometric Coefficient of Variation 25.9 |
| Part 1: GSK3326595 200mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 15 | 4190 h*ng/mL | Geometric Coefficient of Variation 33.1 |
| Part 1: GSK3326595 300mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 1 | 3730 h*ng/mL | Geometric Coefficient of Variation 25.5 |
| Part 1: GSK3326595 300mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 15 | 4140 h*ng/mL | Geometric Coefficient of Variation 28.8 |
| Part 1: GSK3326595 400mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 15 | 8770 h*ng/mL | Geometric Coefficient of Variation 24.1 |
| Part 1: GSK3326595 400mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 1 | 6600 h*ng/mL | Geometric Coefficient of Variation 32.7 |
| Part 1: GSK3326595 600mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 15 | 12900 h*ng/mL | Geometric Coefficient of Variation 32.6 |
| Part 1: GSK3326595 600mg QD | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 1 | 9360 h*ng/mL | Geometric Coefficient of Variation 26.7 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 1 | 250 h*ng/mL | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 15 | 374 h*ng/mL | — |
| Part 1: GSK3326595 100mg BID | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 1 | 819 h*ng/mL | Geometric Coefficient of Variation 46 |
| Part 1: GSK3326595 100mg BID | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 15 | 1010 h*ng/mL | Geometric Coefficient of Variation 41.7 |
| Part 1: GSK3326595 150mg BID | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 1 | 1100 h*ng/mL | Geometric Coefficient of Variation 56.4 |
| Part 1: GSK3326595 150mg BID | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 15 | 2360 h*ng/mL | Geometric Coefficient of Variation 52.3 |
| Part 1: GSK3326595 200mg BID | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 1 | 3970 h*ng/mL | Geometric Coefficient of Variation 63.7 |
| Part 1: GSK3326595 200mg BID | Part 1: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | Day 15 | 4050 h*ng/mL | Geometric Coefficient of Variation 1.2 |
Secondary
Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours (h) post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15
Population: Pharmacokinetic (PK) population included all participants from the All Treated Population for whom a PK sample was obtained and analyzed. Only those participants with data available at specified time points have been analyzed. Data was not available for samples that were out of stability or lost in transit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 1 | 14.1 Nanogram/ millilitre (ng/mL) | — |
| Part 1: GSK3326595 25mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 1 | 70.7 Nanogram/ millilitre (ng/mL) | — |
| Part 1: GSK3326595 25mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 15 | 40.9 Nanogram/ millilitre (ng/mL) | — |
| Part 1: GSK3326595 50mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 1 | 288 Nanogram/ millilitre (ng/mL) | — |
| Part 1: GSK3326595 50mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 15 | 192 Nanogram/ millilitre (ng/mL) | — |
| Part 1: GSK3326595 100mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 1 | 508 Nanogram/ millilitre (ng/mL) | — |
| Part 1: GSK3326595 100mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 15 | 796 Nanogram/ millilitre (ng/mL) | — |
| Part 1: GSK3326595 200mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 15 | 812 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 35.1 |
| Part 1: GSK3326595 200mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 1 | 653 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 40.2 |
| Part 1: GSK3326595 300mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 1 | 853 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 29.4 |
| Part 1: GSK3326595 300mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 15 | 678 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 12.4 |
| Part 1: GSK3326595 400mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 1 | 1340 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 48.4 |
| Part 1: GSK3326595 400mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 15 | 1600 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 63.7 |
| Part 1: GSK3326595 600mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 15 | 2810 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 19.4 |
| Part 1: GSK3326595 600mg QD | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 1 | 1860 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 41.4 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 15 | 85.0 Nanogram/ millilitre (ng/mL) | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 1 | 55.8 Nanogram/ millilitre (ng/mL) | — |
| Part 1: GSK3326595 100mg BID | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 1 | 210 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 61.2 |
| Part 1: GSK3326595 100mg BID | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 15 | 173 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 37.6 |
| Part 1: GSK3326595 150mg BID | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 15 | 368 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 29.8 |
| Part 1: GSK3326595 150mg BID | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 1 | 240 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 93.9 |
| Part 1: GSK3326595 200mg BID | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 1 | 925 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 35.6 |
| Part 1: GSK3326595 200mg BID | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | Day 15 | 822 Nanogram/ millilitre (ng/mL) | Geometric Coefficient of Variation 26.3 |
Secondary
Part 1: Oral Clearance (CL/F) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Population: Pharmacokinetic (PK) population included all participants from the All Treated Population for whom a PK sample was obtained and analyzed. Only those participants with data available at specified time points have been analyzed. Data was not available for samples that were out of stability or lost in transit.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3326595 25mg QD | Part 1: Oral Clearance (CL/F) of GSK3326595 | 71.7 Litre/ hour (L/h) | — |
| Part 1: GSK3326595 50mg QD | Part 1: Oral Clearance (CL/F) of GSK3326595 | 54.0 Litre/ hour (L/h) | — |
| Part 1: GSK3326595 100mg QD | Part 1: Oral Clearance (CL/F) of GSK3326595 | 58.5 Litre/ hour (L/h) | — |
| Part 1: GSK3326595 200mg QD | Part 1: Oral Clearance (CL/F) of GSK3326595 | 61.8 Litre/ hour (L/h) | Geometric Coefficient of Variation 25.3 |
| Part 1: GSK3326595 300mg QD | Part 1: Oral Clearance (CL/F) of GSK3326595 | 79.0 Litre/ hour (L/h) | Geometric Coefficient of Variation 27.2 |
| Part 1: GSK3326595 400mg QD | Part 1: Oral Clearance (CL/F) of GSK3326595 | 59.2 Litre/ hour (L/h) | Geometric Coefficient of Variation 32.2 |
| Part 1: GSK3326595 600mg QD | Part 1: Oral Clearance (CL/F) of GSK3326595 | 62.4 Litre/ hour (L/h) | Geometric Coefficient of Variation 27 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Oral Clearance (CL/F) of GSK3326595 | 355 Litre/ hour (L/h) | — |
| Part 1: GSK3326595 100mg BID | Part 1: Oral Clearance (CL/F) of GSK3326595 | 218 Litre/ hour (L/h) | Geometric Coefficient of Variation 42.9 |
| Part 1: GSK3326595 150mg BID | Part 1: Oral Clearance (CL/F) of GSK3326595 | 239 Litre/ hour (L/h) | Geometric Coefficient of Variation 47.9 |
| Part 1: GSK3326595 200mg BID | Part 1: Oral Clearance (CL/F) of GSK3326595 | 94.1 Litre/ hour (L/h) | Geometric Coefficient of Variation 65.1 |
Secondary
Part 1: Overall Response Rate (ORR) Based on RECIST 1.1
ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) per RECIST version 1.1. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm.
Time frame: Up to 30 months
Population: All treated population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | 0 Percentage of participants |
| Part 1: GSK3326595 25mg QD | Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | 0 Percentage of participants |
| Part 1: GSK3326595 50mg QD | Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | 0 Percentage of participants |
| Part 1: GSK3326595 100mg QD | Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | 0 Percentage of participants |
| Part 1: GSK3326595 200mg QD | Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | 25.0 Percentage of participants |
| Part 1: GSK3326595 300mg QD | Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | 0 Percentage of participants |
| Part 1: GSK3326595 400mg QD | Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | 5.3 Percentage of participants |
| Part 1: GSK3326595 600mg QD | Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | 0 Percentage of participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | 0 Percentage of participants |
| Part 1: GSK3326595 100mg BID | Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | 0 Percentage of participants |
| Part 1: GSK3326595 150mg BID | Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | 0 Percentage of participants |
| Part 1: GSK3326595 200mg BID | Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | 0 Percentage of participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 1: Overall Response Rate (ORR) Based on RECIST 1.1 | 6.7 Percentage of participants |
Secondary
Part 1: Terminal Phase Half-life (t1/2) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 h post-dose; pre-dose on day 8; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose on day 15
Population: Pharmacokinetic (PK) population included all participants from the All Treated Population for whom a PK sample was obtained and analyzed. Only those participants with data available at specified time points have been analyzed. Data was not available for samples that were out of stability or lost in transit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3326595 25mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 1 | 5.58 Hour | — |
| Part 1: GSK3326595 25mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 15 | 4.57 Hour | — |
| Part 1: GSK3326595 50mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 1 | 2.66 Hour | — |
| Part 1: GSK3326595 50mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 15 | 3.32 Hour | — |
| Part 1: GSK3326595 100mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 1 | 2.32 Hour | — |
| Part 1: GSK3326595 100mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 15 | 5.30 Hour | — |
| Part 1: GSK3326595 200mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 1 | 4.82 Hour | Geometric Coefficient of Variation 30.4 |
| Part 1: GSK3326595 200mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 15 | 6.30 Hour | Geometric Coefficient of Variation 19.1 |
| Part 1: GSK3326595 300mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 1 | 3.71 Hour | Geometric Coefficient of Variation 48.5 |
| Part 1: GSK3326595 300mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 15 | 6.68 Hour | Geometric Coefficient of Variation 10.9 |
| Part 1: GSK3326595 400mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 15 | 4.68 Hour | Geometric Coefficient of Variation 33.1 |
| Part 1: GSK3326595 400mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 1 | 4.46 Hour | Geometric Coefficient of Variation 20.9 |
| Part 1: GSK3326595 600mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 15 | 5.71 Hour | Geometric Coefficient of Variation 3.33 |
| Part 1: GSK3326595 600mg QD | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 1 | 5.03 Hour | Geometric Coefficient of Variation 7.25 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 1 | 2.91 Hour | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 15 | 2.93 Hour | — |
| Part 1: GSK3326595 100mg BID | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 1 | 3.28 Hour | Geometric Coefficient of Variation 26.2 |
| Part 1: GSK3326595 100mg BID | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 15 | 4.21 Hour | Geometric Coefficient of Variation 32.8 |
| Part 1: GSK3326595 150mg BID | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 1 | 3.32 Hour | Geometric Coefficient of Variation 37.4 |
| Part 1: GSK3326595 150mg BID | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 15 | 4.59 Hour | Geometric Coefficient of Variation 20.3 |
| Part 1: GSK3326595 200mg BID | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 1 | 2.60 Hour | Geometric Coefficient of Variation 10.4 |
| Part 1: GSK3326595 200mg BID | Part 1: Terminal Phase Half-life (t1/2) of GSK3326595 | Day 15 | 3.76 Hour | Geometric Coefficient of Variation 31.1 |
Secondary
Part 1: Time Invariance (TI) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods. Time invariance was calculated as AUC(0-tau) at Day 15 divided by AUC(0-infinity) at Day 1 for GSK3326595.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 1 and Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose on Day 15
Population: Pharmacokinetic (PK) population.Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3326595 25mg QD | Part 1: Time Invariance (TI) of GSK3326595 | 0.797 Ratio | — |
| Part 1: GSK3326595 50mg QD | Part 1: Time Invariance (TI) of GSK3326595 | 0.717 Ratio | — |
| Part 1: GSK3326595 100mg QD | Part 1: Time Invariance (TI) of GSK3326595 | 1.20 Ratio | — |
| Part 1: GSK3326595 200mg QD | Part 1: Time Invariance (TI) of GSK3326595 | 1.29 Ratio | Geometric Coefficient of Variation 32.7 |
| Part 1: GSK3326595 300mg QD | Part 1: Time Invariance (TI) of GSK3326595 | 1.09 Ratio | Geometric Coefficient of Variation 8.78 |
| Part 1: GSK3326595 400mg QD | Part 1: Time Invariance (TI) of GSK3326595 | 1.31 Ratio | Geometric Coefficient of Variation 20.8 |
| Part 1: GSK3326595 600mg QD | Part 1: Time Invariance (TI) of GSK3326595 | 1.56 Ratio | Geometric Coefficient of Variation 23.1 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 1: Time Invariance (TI) of GSK3326595 | 1.33 Ratio | — |
| Part 1: GSK3326595 100mg BID | Part 1: Time Invariance (TI) of GSK3326595 | 1.10 Ratio | Geometric Coefficient of Variation 56.2 |
| Part 1: GSK3326595 150mg BID | Part 1: Time Invariance (TI) of GSK3326595 | 1.98 Ratio | Geometric Coefficient of Variation 33.7 |
| Part 1: GSK3326595 200mg BID | Part 1: Time Invariance (TI) of GSK3326595 | 1.34 Ratio | Geometric Coefficient of Variation 12.4 |
Secondary
Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH)
Urine samples were collected from participants to assess urine pH levels.
Time frame: Baseline (Day 1) and up to week 184
Population: All treated population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | -1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.29 Potential of Hydrogen (pH) | Standard Deviation 0.902 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.17 Potential of Hydrogen (pH) | Standard Deviation 0.842 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 0.57 Potential of Hydrogen (pH) | Standard Deviation 1.018 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | -1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.95 Potential of Hydrogen (pH) | Standard Deviation 0.8 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | -0.75 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 36 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 44 | -1.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | 0.07 Potential of Hydrogen (pH) | Standard Deviation 0.795 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.31 Potential of Hydrogen (pH) | Standard Deviation 0.727 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -0.50 Potential of Hydrogen (pH) | Standard Deviation 0.632 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | -0.16 Potential of Hydrogen (pH) | Standard Deviation 0.7 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.54 Potential of Hydrogen (pH) | Standard Deviation 0.594 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.06 Potential of Hydrogen (pH) | Standard Deviation 0.704 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 60 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.866 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 68 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 72 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 44 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 76 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 80 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 1.061 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 28 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.854 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 84 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 88 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 52 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 92 | -1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 96 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 36 | -0.17 Potential of Hydrogen (pH) | Standard Deviation 0.764 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 100 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 104 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 56 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 108 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 112 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 116 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 120 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 124 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 128 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 132 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.816 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.19 Potential of Hydrogen (pH) | Standard Deviation 0.772 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | -0.50 Potential of Hydrogen (pH) | Standard Deviation 0.791 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | 0.14 Potential of Hydrogen (pH) | Standard Deviation 0.988 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.694 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 1.414 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.03 Potential of Hydrogen (pH) | Standard Deviation 0.899 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.15 Potential of Hydrogen (pH) | Standard Deviation 0.525 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.11 Potential of Hydrogen (pH) | Standard Deviation 0.706 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -0.31 Potential of Hydrogen (pH) | Standard Deviation 0.651 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.03 Potential of Hydrogen (pH) | Standard Deviation 0.591 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.97 Potential of Hydrogen (pH) | Standard Deviation 0.706 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | 1.25 Potential of Hydrogen (pH) | Standard Deviation 1.061 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | -0.17 Potential of Hydrogen (pH) | Standard Deviation 0.931 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -0.16 Potential of Hydrogen (pH) | Standard Deviation 0.67 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.42 Potential of Hydrogen (pH) | Standard Deviation 0.767 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | 1.00 Potential of Hydrogen (pH) | Standard Deviation 1.414 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 64 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | 0.67 Potential of Hydrogen (pH) | Standard Deviation 0.577 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.24 Potential of Hydrogen (pH) | Standard Deviation 0.76 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.23 Potential of Hydrogen (pH) | Standard Deviation 0.741 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 0.866 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 28 | 1.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | 0.23 Potential of Hydrogen (pH) | Standard Deviation 0.932 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.01 Potential of Hydrogen (pH) | Standard Deviation 0.809 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.35 Potential of Hydrogen (pH) | Standard Deviation 0.715 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 56 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 0.58 Potential of Hydrogen (pH) | Standard Deviation 1.201 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.08 Potential of Hydrogen (pH) | Standard Deviation 0.929 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -0.38 Potential of Hydrogen (pH) | Standard Deviation 0.944 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | -0.02 Potential of Hydrogen (pH) | Standard Deviation 0.62 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.00 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.04 Potential of Hydrogen (pH) | Standard Deviation 0.693 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | 0.10 Potential of Hydrogen (pH) | Standard Deviation 0.568 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | 0.20 Potential of Hydrogen (pH) | Standard Deviation 0.837 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.837 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 68 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | -0.50 Potential of Hydrogen (pH) | Standard Deviation 1.027 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 52 | 0.38 Potential of Hydrogen (pH) | Standard Deviation 0.629 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 56 | -0.20 Potential of Hydrogen (pH) | Standard Deviation 0.57 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 60 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 64 | -0.50 Potential of Hydrogen (pH) | Standard Deviation 0.447 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 72 | -0.50 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 76 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 80 | -0.38 Potential of Hydrogen (pH) | Standard Deviation 0.479 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 84 | 2.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 88 | -0.30 Potential of Hydrogen (pH) | Standard Deviation 0.671 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 92 | 1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 96 | 0.17 Potential of Hydrogen (pH) | Standard Deviation 1.443 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 104 | -1.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.15 Potential of Hydrogen (pH) | Standard Deviation 0.784 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.15 Potential of Hydrogen (pH) | Standard Deviation 0.892 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.03 Potential of Hydrogen (pH) | Standard Deviation 0.73 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.32 Potential of Hydrogen (pH) | Standard Deviation 0.793 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.48 Potential of Hydrogen (pH) | Standard Deviation 0.886 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -0.30 Potential of Hydrogen (pH) | Standard Deviation 0.968 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | -0.33 Potential of Hydrogen (pH) | Standard Deviation 1 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | -0.23 Potential of Hydrogen (pH) | Standard Deviation 1.032 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | -0.19 Potential of Hydrogen (pH) | Standard Deviation 0.799 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | -0.66 Potential of Hydrogen (pH) | Standard Deviation 1.012 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 28 | -0.75 Potential of Hydrogen (pH) | Standard Deviation 1.258 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | -0.62 Potential of Hydrogen (pH) | Standard Deviation 1.121 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 36 | -0.20 Potential of Hydrogen (pH) | Standard Deviation 0.57 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | -0.54 Potential of Hydrogen (pH) | Standard Deviation 0.946 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 44 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 0.866 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 56 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.27 Potential of Hydrogen (pH) | Standard Deviation 0.942 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.15 Potential of Hydrogen (pH) | Standard Deviation 0.966 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 52 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 44 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.07 Potential of Hydrogen (pH) | Standard Deviation 0.842 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.19 Potential of Hydrogen (pH) | Standard Deviation 0.693 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.645 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.783 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 64 | -0.50 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 72 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 28 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 80 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | -0.67 Potential of Hydrogen (pH) | Standard Deviation 0.606 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.629 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 88 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.36 Potential of Hydrogen (pH) | Standard Deviation 0.842 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.629 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | 0.31 Potential of Hydrogen (pH) | Standard Deviation 0.704 |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 0.13 Potential of Hydrogen (pH) | Standard Deviation 0.629 |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | -1.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.25 |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 96 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.90 Potential of Hydrogen (pH) | Standard Deviation 0.224 |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 168 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 184 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 176 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 160 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 80 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 152 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 144 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 136 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 112 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 72 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.20 Potential of Hydrogen (pH) | Standard Deviation 0.447 |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.25 |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.10 Potential of Hydrogen (pH) | Standard Deviation 0.548 |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.75 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | -0.17 Potential of Hydrogen (pH) | Standard Deviation 0.764 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.10 Potential of Hydrogen (pH) | Standard Deviation 0.822 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.21 Potential of Hydrogen (pH) | Standard Deviation 0.859 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.935 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.25 Potential of Hydrogen (pH) | Standard Deviation 0.845 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 0.75 Potential of Hydrogen (pH) | Standard Deviation 1.061 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.964 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.612 |
| Part 1: GSK3326595 150mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.50 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 150mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 150mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 150mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 150mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 150mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.14 Potential of Hydrogen (pH) | Standard Deviation 0.627 |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -0.10 Potential of Hydrogen (pH) | Standard Deviation 0.822 |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.06 Potential of Hydrogen (pH) | Standard Deviation 0.464 |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.06 Potential of Hydrogen (pH) | Standard Deviation 0.464 |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.17 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | 0.33 Potential of Hydrogen (pH) | Standard Deviation 0.5 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.33 Potential of Hydrogen (pH) | Standard Deviation 0.606 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.577 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.07 Potential of Hydrogen (pH) | Standard Deviation 0.189 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.43 Potential of Hydrogen (pH) | Standard Deviation 0.345 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 0.10 Potential of Hydrogen (pH) | Standard Deviation 0.224 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 64 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | 0.07 Potential of Hydrogen (pH) | Standard Deviation 0.189 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 56 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 72 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | 0.75 Potential of Hydrogen (pH) | Standard Deviation 1.061 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | 0.00 Potential of Hydrogen (pH) | — |
Secondary
Part 2: Changes From Baseline in Urine Specific Gravity
Urine samples were collected from participants to assess urine specific gravity.
Time frame: Baseline (Day 1) and up to week 184
Population: All treated population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 44 | 0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0.002 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 36 | 0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | 0.00 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 92 | 0.00 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 88 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 84 | 0.00 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 80 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 124 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 120 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 116 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 112 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 108 | 0.00 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 104 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 100 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 96 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 76 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 72 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 68 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 60 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 56 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 52 | -0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | -0.01 Ratio | Standard Deviation 0 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 44 | 0.00 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | -0.01 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 36 | 0.00 Ratio | Standard Deviation 0.003 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 132 | 0.00 Ratio | — |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 28 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 25mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 128 | -0.01 Ratio | — |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | — |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.00 Ratio | — |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 50mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | 0.01 Ratio | Standard Deviation 0.013 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | NA Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.029 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 64 | 0.01 Ratio | — |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 56 | -0.01 Ratio | — |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 100mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 28 | -0.01 Ratio | Standard Deviation 0.021 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | 0.01 Ratio | — |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.00 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.01 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 200mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | 0.01 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | 0.00 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 1.02 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.00 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 28 | 0.00 Ratio | Standard Deviation 0.015 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0.012 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 36 | 0.01 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | 0.00 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 44 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | 0.01 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 52 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 56 | -0.01 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 60 | -0.01 Ratio | Standard Deviation 0.001 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 64 | 0.00 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 68 | -0.01 Ratio | Standard Deviation 0.002 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 72 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 76 | -0.01 Ratio | — |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 80 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 84 | -0.01 Ratio | — |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 88 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 92 | -0.01 Ratio | — |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 96 | 0.00 Ratio | Standard Deviation 0.017 |
| Part 1: GSK3326595 300mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 104 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | -0.01 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 88 | 0.01 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 44 | 0.02 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 28 | 0.00 Ratio | Standard Deviation 0.023 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | 0.01 Ratio | Standard Deviation 0.013 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.01 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 52 | 0.02 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 80 | 0.00 Ratio | — |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | 0.01 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 56 | 0.01 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 64 | 0.00 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 72 | 0.00 Ratio | Standard Deviation 0.001 |
| Part 1: GSK3326595 400mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | -0.02 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 144 | 0.02 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.012 |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.003 |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.02 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | -0.01 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.01 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 136 | 0.02 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.02 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 96 | 0.02 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 184 | 0.02 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 176 | 0.02 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 168 | 0.02 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | 0.02 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 80 | 0.02 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 112 | 0.02 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 160 | 0.02 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 152 | 0.01 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 72 | 0.01 Ratio | — |
| Part 1: GSK3326595 600mg QD | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.01 Ratio | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | -0.01 Ratio | — |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | — |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.01 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.01 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | — |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.003 |
| Part 1: GSK3326595 100mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0 |
| Part 1: GSK3326595 150mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | -0.01 Ratio | — |
| Part 1: GSK3326595 150mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | -0.01 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 150mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | Baseline | 1.03 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 150mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | -0.01 Ratio | — |
| Part 1: GSK3326595 150mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0 |
| Part 1: GSK3326595 150mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0 |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | -0.01 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.00 Ratio | — |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0 |
| Part 1: GSK3326595 200mg BID | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | 0.00 Ratio | Standard Deviation 0.002 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | -0.01 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 64 | 0.01 Ratio | — |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.01 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.01 Ratio | — |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0.001 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.01 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 72 | 0.00 Ratio | — |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Week 56 | 0.01 Ratio | — |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.005 |
Secondary
Part 2: Duration of Response (DOR) (ACC Tablet Cohort)
Duration of response (DOR) was defined as time from first evidence of response (CR or PR per RECIST 1.1) to earlier date of disease progression or death due to any cause, as determined by Investigator assessment.
Time frame: Up to 42 months
Population: All treated population. Only participants with response in ACC tablets cohort were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Duration of Response (DOR) (ACC Tablet Cohort) | NA Months |
Secondary
Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or was associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the MedDRA dictionary.
Time frame: Up to 42 months
Population: All treated population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 22 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 13 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 16 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 7 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 27 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 15 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 37 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 10 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 13 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 28 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 15 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 34 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 16 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 5 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 6 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 4 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 8 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 11 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 7 Participants |
Secondary
Part 2: Number of Participants With Dose Modifications of GSK3326595
The number of participants who had any dose modifications (interruptions and reductions) of GSK3326595 have been presented.
Time frame: Up to 42 months
Population: All treated population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 13 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 8 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 12 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 11 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 11 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 11 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 22 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 26 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 18 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 20 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 27 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 28 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 13 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 7 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 4 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 5 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 6 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose reductions | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Dose Modifications of GSK3326595 | Dose interruptions | 2 Participants |
Secondary
Part 2: Number of Participants Withdrawn Due to AEs
The data for number of participants withdrawn due to AEs have been presented.
Time frame: Up to 42 months
Population: All treated population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants Withdrawn Due to AEs | 4 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants Withdrawn Due to AEs | 4 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants Withdrawn Due to AEs | 4 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants Withdrawn Due to AEs | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants Withdrawn Due to AEs | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants Withdrawn Due to AEs | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants Withdrawn Due to AEs | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants Withdrawn Due to AEs | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants Withdrawn Due to AEs | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants Withdrawn Due to AEs | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants Withdrawn Due to AEs | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants Withdrawn Due to AEs | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants Withdrawn Due to AEs | 1 Participants |
Secondary
Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs
The abnormal vital sign ranges are: Heart Rate:- Low (\<60 beats per minute (bpm)), Normal (\>=60 bpm to \<=100 bpm), High (\>100 bpm); Temperature:- Low (\<=35 degree Celsius (C)), Normal (\>35 C and \<38 C), High (\>=38 C); Systolic Blood Pressure:- Low (\<90 millimeter of mercury (mmHg)), Normal (\>=90 mmHg to \<120 mmHg), High (\>=120 mmHg); Diastolic Blood Pressure:- Low (\<60 mmHg), Normal (\>=60 mmHg to \<80 mmHg), High (\>=80 mmHg). Participants were counted in the worst-case category and their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Baseline (Day 1) and up to 42 months
Population: All treated population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 21 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 4 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 7 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 5 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 2 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 9 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 4 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 3 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 6 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 3 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 6 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 8 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 2 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 6 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 20 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 2 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 28 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 20 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 16 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 11 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 16 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 3 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 9 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 36 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 28 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 21 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 6 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 9 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 18 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 5 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 9 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 10 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 8 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 31 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 6 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 23 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 21 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 11 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Maximum Grade Worst Case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
Secondary
Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Baseline (Day 1) and up to 42 months
Population: All treated population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 5 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 18 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 7 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 7 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 5 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 20 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 2 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 3 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 5 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 2 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 4 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 3 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 9 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 5 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 2 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 6 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 5 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 5 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 7 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 6 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 5 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 3 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 4 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 4 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 6 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 27 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 5 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 4 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 5 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 3 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 12 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 6 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 4 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 22 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 21 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 3 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 2 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 6 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 21 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 3 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 3 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 3 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 9 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 12 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 24 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 3 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 22 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 22 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 30 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 31 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 8 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 15 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 7 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 10 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 28 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 7 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 7 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 24 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 2 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 8 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 30 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 24 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 2 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 5 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 3 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 5 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 8 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 29 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 10 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 5 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 7 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 27 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 30 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 2 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 2 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 6 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 5 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 30 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 4 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 5 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 22 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 7 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 31 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 23 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 6 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 22 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 11 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 12 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 14 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 23 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 6 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 10 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 6 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 24 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 6 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 6 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 22 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 8 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 9 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 23 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 26 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 19 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 4 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 28 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 5 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 11 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 13 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 30 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 23 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 6 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 20 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 14 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 4 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 15 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 26 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 6 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 23 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 10 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 13 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 20 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 6 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 8 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 4 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 4 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 4 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 6 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 6 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 4 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 5 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 7 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 4 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 1 Participants |
Secondary
Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters
Blood samples were collected for evaluation of coagulation parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Baseline (Day 1) and up to 42 months
Population: All treated population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 5 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 13 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 8 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 4 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 10 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 14 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 5 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 3 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 8 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 2 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 18 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 23 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 21 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 24 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 16 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 13 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 10 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 6 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 13 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 18 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 17 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 12 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 18 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 8 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 8 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 3 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 4 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 5 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 5 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 1 Participants |
Secondary
Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters
Blood samples were collected for evaluation of hematology parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high values' have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Baseline (Day 1) and up to 42 months
Population: All treated population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 21 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 10 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 4 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 13 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 14 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 18 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 9 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 11 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 20 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 11 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 21 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 13 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 5 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 10 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 5 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 2 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 12 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 9 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 6 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 8 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 4 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 3 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 7 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 13 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 3 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 4 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 2 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 2 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 3 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 6 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 8 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 13 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 23 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 12 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 28 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 8 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 3 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 9 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 3 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 8 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 3 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 20 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 20 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 13 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 2 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 20 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 18 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 26 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 24 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 2 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 11 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 28 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 5 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 18 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 2 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 3 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 35 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 2 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 17 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 33 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 3 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 2 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 28 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 5 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 29 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 5 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 15 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 9 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 2 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 18 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 15 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 17 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 20 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 3 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 22 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 8 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 12 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 29 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 21 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 28 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 16 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 20 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 26 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 12 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 3 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 18 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 11 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 26 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 11 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 12 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 7 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 5 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 15 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 14 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 6 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 6 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 8 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 4 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 22 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 26 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 22 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 20 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 15 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 24 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 14 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 33 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 19 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 29 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 21 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 22 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 10 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 3 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 10 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 4 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 15 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 29 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 10 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 11 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 8 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 4 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 6 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 5 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 4 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 5 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 5 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 10 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 10 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 4 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 1 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 6 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 5 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 9 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 10 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 4 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 5 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 7 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 1 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 5 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 5 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 1 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 2 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 1 Participants |
Secondary
Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters
Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented.
Time frame: Baseline (Day 1) and up to 42 months
Population: All treated population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 13 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 19 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 9 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 17 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 5 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 20 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 2 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 9 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 9 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 10 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 15 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 7 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 7 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 6 Participants |
| Part 1: GSK3326595 25mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 1 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 13 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 6 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 4 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 8 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 24 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 20 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 22 Participants |
| Part 1: GSK3326595 50mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 15 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 9 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 5 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 13 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 27 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 32 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 24 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 10 Participants |
| Part 1: GSK3326595 100mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 28 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 20 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 10 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 4 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 14 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 18 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 24 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 14 Participants |
| Part 1: GSK3326595 200mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 8 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 17 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 20 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 10 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 24 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 14 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 34 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 300mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 17 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 14 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 9 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 13 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 3 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 7 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 2 Participants |
| Part 1: GSK3326595 400mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 9 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 3 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 4 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 1 Participants |
| Part 1: GSK3326595 600mg QD | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 5 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 0 Participants |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 7 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 5 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 0 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 8 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 3 Participants |
| Part 1: GSK3326595 100mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 1 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 0 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 150mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 7 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 5 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 2 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 4 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 9 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 6 Participants |
| Part 1: GSK3326595 200mg BID | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 7 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 5 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 4 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 3 Participants |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 2 Participants |
Secondary
Part 2: ORR (GBM Cohort) Based on Response Assessment Neuro-Oncology (RANO) Working Group Criteria
ORR was defined as the percentage of participants with a CR or PR, confirmed no less than 4 weeks based on the RANO criteria. CR was defined as complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks, stable or improved non-enhancing (T2/FLAIR) lesions, no new lesions, participants must be off corticosteroids (or on physiologic replacement doses only), and clinically stable or improved. PR was defined as at least 50% decrease compared to Baseline in the size of all measurable enhancing lesions sustained for at least 4 weeks, no progression of non-measurable disease or any new lesions, stable of lower dose of corticosteroids than Baseline dose, and stable or improved non-enhancing (T2/FLAIR) lesions.
Time frame: Up to 42 months
Population: All treated population. Only participants in GBM cohort were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: ORR (GBM Cohort) Based on Response Assessment Neuro-Oncology (RANO) Working Group Criteria | 0 Percentage of participants |
Secondary
Part 2: ORR (Non-Hodgkin's Lymphoma (NHL) Cohorts) Based on Lugano Criteria
ORR was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Lugano Criteria for Non-Hodgkin's lymphoma cohorts.
Time frame: Up to 42 months
Population: All treated population. Only participants in NHL cohorts were analyzed. For this analysis 300mg and 400 mg GSK3326595 arms were pooled based on NHL type to primarily serve the purpose for the comparison among the NHL cohorts.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: ORR (Non-Hodgkin's Lymphoma (NHL) Cohorts) Based on Lugano Criteria | 12.5 Percentage of participants |
| Part 1: GSK3326595 25mg QD | Part 2: ORR (Non-Hodgkin's Lymphoma (NHL) Cohorts) Based on Lugano Criteria | 10.0 Percentage of participants |
| Part 1: GSK3326595 50mg QD | Part 2: ORR (Non-Hodgkin's Lymphoma (NHL) Cohorts) Based on Lugano Criteria | 9.1 Percentage of participants |
Secondary
Part 2: Overall Response Rate (ORR) (Non-glioblastoma Multiforme [GBM] Cohorts)
Overall response rate (ORR) was defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response (CR) was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm).
Time frame: Up to 42 months
Population: All treated population. Only participants in non-GBM cohorts were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Overall Response Rate (ORR) (Non-glioblastoma Multiforme [GBM] Cohorts) | 0 Percentage of participants |
| Part 1: GSK3326595 25mg QD | Part 2: Overall Response Rate (ORR) (Non-glioblastoma Multiforme [GBM] Cohorts) | 0 Percentage of participants |
| Part 1: GSK3326595 50mg QD | Part 2: Overall Response Rate (ORR) (Non-glioblastoma Multiforme [GBM] Cohorts) | 2.7 Percentage of participants |
| Part 1: GSK3326595 100mg QD | Part 2: Overall Response Rate (ORR) (Non-glioblastoma Multiforme [GBM] Cohorts) | 0 Percentage of participants |
| Part 1: GSK3326595 200mg QD | Part 2: Overall Response Rate (ORR) (Non-glioblastoma Multiforme [GBM] Cohorts) | 2.9 Percentage of participants |
| Part 1: GSK3326595 300mg QD | Part 2: Overall Response Rate (ORR) (Non-glioblastoma Multiforme [GBM] Cohorts) | 6.3 Percentage of participants |
| Part 1: GSK3326595 400mg QD | Part 2: Overall Response Rate (ORR) (Non-glioblastoma Multiforme [GBM] Cohorts) | 0 Percentage of participants |
Secondary
Part 2: Overall Survival (OS) (ACC Tablet Cohort)
Overall survival (OS) was defined as time from first dose until death from any cause in ACC participants who are systemic-treatment naïve.
Time frame: Up to 42 months
Population: All treated population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Overall Survival (OS) (ACC Tablet Cohort) | NA Months |
Secondary
Part 2: Progression-free Survival
PFS was defined as time from first dose until radiographic progression per standard criteria or death due to any cause, whichever is earlier.
Time frame: Up to 42 months
Population: All treated population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Progression-free Survival | 1.5 Months |
| Part 1: GSK3326595 25mg QD | Part 2: Progression-free Survival | 3.6 Months |
| Part 1: GSK3326595 50mg QD | Part 2: Progression-free Survival | 2.1 Months |
| Part 1: GSK3326595 100mg QD | Part 2: Progression-free Survival | 3.2 Months |
| Part 1: GSK3326595 200mg QD | Part 2: Progression-free Survival | 7.2 Months |
| Part 1: GSK3326595 300mg QD | Part 2: Progression-free Survival | 7.1 Months |
| Part 1: GSK3326595 400mg QD | Part 2: Progression-free Survival | 4.3 Months |
| Part 1: GSK3326595 600mg QD | Part 2: Progression-free Survival | 1.3 Months |
| Part 1: GSK3326595 50mg Twice Daily (BID) | Part 2: Progression-free Survival | 2.6 Months |
| Part 1: GSK3326595 100mg BID | Part 2: Progression-free Survival | 2.7 Months |
| Part 1: GSK3326595 150mg BID | Part 2: Progression-free Survival | 2.6 Months |
| Part 1: GSK3326595 200mg BID | Part 2: Progression-free Survival | 4.5 Months |
| Part 1: GSK3326595 300mg QD (Food Effect) | Part 2: Progression-free Survival | 2.2 Months |
Secondary
Part 2: Six-month Progression Free Survival (PFS) Rate (GBM Cohort)
Six-month progression free survival (PFS) rate was defined as the percentage of participants free from radiographic progression per Response Assessment in Neuro-Oncology (RANO) criteria, or death due to any cause, for six months after starting GSK3326595. The RANO criteria were used to ascertain response (Wen, 2010).
Time frame: At month 6
Population: All treated population. Only participants in GBM cohort was analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 2: Six-month Progression Free Survival (PFS) Rate (GBM Cohort) | 4 Percentage of participants |
Secondary
Part 3: Accumulation Ratio (AR) of GSK3326595
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Population: Pharmacokinetic (PK) population. Due to bioanalytical issues, PK data was not collected and analyzed. Therefore, this PK parameter was not reported in this study.
Secondary
Part 3: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Area Under the Plasma Concentration-time Curve (AUC) Extrapolated From Time Zero to Infinity (AUC[0-inf]) of GSK3326595 | 1770 h*ng/mL | Geometric Coefficient of Variation 62.9 |
Secondary
Part 3: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Population: Pharmacokinetic (PK) population. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: AUC From Time Zero to the Last Quantifiable Concentration After Dosing (AUC[0-t]) of GSK3326595 | 1480 h*ng/mL | Geometric Coefficient of Variation 68.5 |
Secondary
Part 3: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Population: Pharmacokinetic (PK) population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3326595 | 1640 h*ng/mL | Geometric Coefficient of Variation 64.6 |
Secondary
Part 3: Maximum Observed Plasma Concentration (Cmax) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Maximum Observed Plasma Concentration (Cmax) of GSK3326595 | 291 ng/mL | Geometric Coefficient of Variation 112 |
Secondary
Part 3: Oral Clearance (CL/F) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Population: Pharmacokinetic (PK) population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Oral Clearance (CL/F) of GSK3326595 | 56.4 L/h | Geometric Coefficient of Variation 62.9 |
Secondary
Part 3: ORR Based on Immune-based RECIST (iRECIST) Criteria
ORR was defined as the percentage of participants with irCR or irPR per irRECIST. irCR is defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). irPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Time frame: Up to 10 months
Population: All treated population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: ORR Based on Immune-based RECIST (iRECIST) Criteria | 0 Percentage of participants |
Secondary
Part 3: Terminal Phase Half-life (t1/2) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Population: Pharmacokinetic (PK) population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | Part 3: Terminal Phase Half-life (t1/2) of GSK3326595 | 5.44 Hour | Geometric Coefficient of Variation 55.8 |
Secondary
Part 3: Time Invariance (TI) of GSK3326595
Blood samples were collected for pharmacokinetic (PK) analysis of GSK3326595.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24h post-dose
Population: Pharmacokinetic (PK) population. Due to bioanalytical issues, PK data was not collected and analyzed. Therefore, this PK parameter was not reported in this study.
Secondary
RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH)
Urine samples were collected from participants to assess urine pH levels.
Time frame: Baseline (Day 1) and up to Week 184
Population: All treated population. For recommended phase 2 dose (RP2D) analysis, Part 1 and Part 2 arms were pooled based on dosage of GSK3326595. Only those participants with data available at specified time point have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 52 | 0.30 Potential of Hydrogen (pH) | Standard Deviation 0.57 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 96 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 1.061 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 56 | -0.14 Potential of Hydrogen (pH) | Standard Deviation 0.476 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 6.11 Potential of Hydrogen (pH) | Standard Deviation 0.729 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 92 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 1.414 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 60 | 0.17 Potential of Hydrogen (pH) | Standard Deviation 0.764 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 88 | -0.33 Potential of Hydrogen (pH) | Standard Deviation 0.606 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 64 | -0.43 Potential of Hydrogen (pH) | Standard Deviation 0.45 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 176 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 84 | 0.75 Potential of Hydrogen (pH) | Standard Deviation 1.768 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 68 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.5 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 80 | -0.33 Potential of Hydrogen (pH) | Standard Deviation 0.408 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 72 | -0.38 Potential of Hydrogen (pH) | Standard Deviation 0.694 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 152 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 76 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -0.20 Potential of Hydrogen (pH) | Standard Deviation 0.823 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.01 Potential of Hydrogen (pH) | Standard Deviation 0.722 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 144 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | -0.06 Potential of Hydrogen (pH) | Standard Deviation 0.873 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.711 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 136 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | -0.11 Potential of Hydrogen (pH) | Standard Deviation 0.859 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 168 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 132 | 0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | -0.03 Potential of Hydrogen (pH) | Standard Deviation 0.757 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 128 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | -0.15 Potential of Hydrogen (pH) | Standard Deviation 1.02 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.16 Potential of Hydrogen (pH) | Standard Deviation 0.769 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 124 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 28 | -0.05 Potential of Hydrogen (pH) | Standard Deviation 1.128 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 120 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | -0.22 Potential of Hydrogen (pH) | Standard Deviation 0.98 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 184 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 116 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 36 | -0.22 Potential of Hydrogen (pH) | Standard Deviation 0.565 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 112 | -0.50 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | -0.28 Potential of Hydrogen (pH) | Standard Deviation 1.074 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 160 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 108 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 44 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 1.061 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 104 | -1.00 Potential of Hydrogen (pH) | Standard Deviation 0.5 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | -0.12 Potential of Hydrogen (pH) | Standard Deviation 1.068 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.20 Potential of Hydrogen (pH) | Standard Deviation 0.807 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 100 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 56 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.64 Potential of Hydrogen (pH) | Standard Deviation 0.413 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.04 Potential of Hydrogen (pH) | Standard Deviation 0.257 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.48 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.08 Potential of Hydrogen (pH) | Standard Deviation 0.494 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | 0.30 Potential of Hydrogen (pH) | Standard Deviation 0.483 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | -0.06 Potential of Hydrogen (pH) | Standard Deviation 0.464 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | 0.50 Potential of Hydrogen (pH) | Standard Deviation 0.866 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 64 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 72 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 72 | -0.20 Potential of Hydrogen (pH) | Standard Deviation 0.57 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 76 | -0.75 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 68 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.866 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 80 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.707 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 64 | -0.40 Potential of Hydrogen (pH) | Standard Deviation 0.652 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 84 | 0.00 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 60 | -1.00 Potential of Hydrogen (pH) | Standard Deviation 0.5 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 88 | -0.17 Potential of Hydrogen (pH) | Standard Deviation 0.764 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 56 | -0.42 Potential of Hydrogen (pH) | Standard Deviation 0.492 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 92 | -0.75 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 52 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.274 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 96 | -0.33 Potential of Hydrogen (pH) | Standard Deviation 0.289 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 48 | -0.33 Potential of Hydrogen (pH) | Standard Deviation 0.661 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 100 | -0.25 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 44 | -0.10 Potential of Hydrogen (pH) | Standard Deviation 0.742 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 104 | -0.83 Potential of Hydrogen (pH) | Standard Deviation 0.289 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 40 | -0.17 Potential of Hydrogen (pH) | Standard Deviation 0.661 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 108 | -1.00 Potential of Hydrogen (pH) | Standard Deviation 0 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 36 | -0.63 Potential of Hydrogen (pH) | Standard Deviation 0.479 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 112 | -0.50 Potential of Hydrogen (pH) | Standard Deviation 0.866 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 32 | -0.06 Potential of Hydrogen (pH) | Standard Deviation 0.95 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 116 | -0.75 Potential of Hydrogen (pH) | Standard Deviation 0.354 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 28 | -0.21 Potential of Hydrogen (pH) | Standard Deviation 0.488 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 120 | -0.33 Potential of Hydrogen (pH) | Standard Deviation 0.289 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 24 | -0.64 Potential of Hydrogen (pH) | Standard Deviation 0.505 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 124 | -0.50 Potential of Hydrogen (pH) | — |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 20 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.791 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 128 | -0.33 Potential of Hydrogen (pH) | Standard Deviation 0.764 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 16 | 0.17 Potential of Hydrogen (pH) | Standard Deviation 0.615 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 12 | 0.00 Potential of Hydrogen (pH) | Standard Deviation 0.957 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 8 | 0.05 Potential of Hydrogen (pH) | Standard Deviation 0.805 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 6 Day 1 | -0.17 Potential of Hydrogen (pH) | Standard Deviation 0.899 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Week 4 Day 1 | -0.13 Potential of Hydrogen (pH) | Standard Deviation 0.888 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 15 | 0.05 Potential of Hydrogen (pH) | Standard Deviation 0.77 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | CFB to Day 8 | -0.11 Potential of Hydrogen (pH) | Standard Deviation 0.599 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline | 5.98 Potential of Hydrogen (pH) | Standard Deviation 0.901 |
Secondary
RP2D Phase: Changes From Baseline in Urine Specific Gravity
Urine samples were collected from participants to assess urine specific gravity.
Time frame: Baseline (Day 1) and up to Week 184
Population: All treated population. For recommended phase 2 dose (RP2D) analysis, Part 1 and Part 2 arms were pooled based on dosage of GSK3326595. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 52 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 96 | 0.00 Ratio | Standard Deviation 0.017 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 56 | -0.01 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 92 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 60 | -0.01 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 88 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 64 | 0.00 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 184 | 0.02 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 84 | -0.01 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 68 | -0.01 Ratio | Standard Deviation 0.002 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 80 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 72 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 160 | 0.02 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 76 | -0.01 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.016 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 152 | 0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 144 | 0.02 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 176 | 0.02 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 136 | 0.02 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 132 | 0.00 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 128 | -0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 28 | 0.00 Ratio | Standard Deviation 0.012 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 124 | -0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 100 | -0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 120 | -0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 36 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 116 | -0.01 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 168 | 0.02 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 112 | 0.01 Ratio | Standard Deviation 0.02 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 44 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 108 | 0.00 Ratio | — |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | 0.01 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 104 | 0.00 Ratio | Standard Deviation 0.003 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 56 | 0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.00 Ratio | Standard Deviation 0.015 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0.001 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | -0.01 Ratio | Standard Deviation 0.011 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | 0.00 Ratio | Standard Deviation 0.002 |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 64 | 0.01 Ratio | — |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 72 | 0.00 Ratio | — |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 72 | 0.00 Ratio | Standard Deviation 0.001 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 76 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 68 | 0.00 Ratio | Standard Deviation 0.003 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 80 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 64 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 84 | 0.00 Ratio | — |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 60 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 88 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 56 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 92 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 52 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 100 | 0.00 Ratio | Standard Deviation 0.001 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 48 | 0.00 Ratio | Standard Deviation 0.009 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 104 | -0.01 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 44 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 108 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 40 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 112 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 36 | 0.00 Ratio | Standard Deviation 0.002 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 116 | 0.00 Ratio | Standard Deviation 0.004 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 32 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 120 | 0.01 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 28 | 0.00 Ratio | Standard Deviation 0.01 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 124 | 0.01 Ratio | — |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 24 | 0.00 Ratio | Standard Deviation 0.005 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 128 | 0.01 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 20 | 0.00 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 16 | 0.00 Ratio | Standard Deviation 0.007 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 12 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 8 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 6 Day 1 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 4 Day 1 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Day 15 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Day 8 | 0.00 Ratio | Standard Deviation 0.008 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | CFB to Week 96 | 0.00 Ratio | Standard Deviation 0.003 |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Changes From Baseline in Urine Specific Gravity | Baseline | 1.02 Ratio | Standard Deviation 0.007 |
Secondary
RP2D Phase: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or was associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the MedDRA dictionary.
Time frame: Up to maximum 42 months
Population: All treated population. For recommended phase 2 dose (RP2D) analysis, Part 1 and Part 2 arms were pooled based on dosage of GSK3326595.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 199 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 92 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 14 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 3 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 31 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 11 Participants |
Secondary
RP2D Phase: Number of Participants With Dose Modifications of GSK3326595
The number of participants who experienced any dose modifications (interruptions and reductions) of GSK3326595 have been presented.
Time frame: Up to maximum 42 months
Population: All treated population. For recommended phase 2 dose (RP2D) analysis, Part 1 and Part 2 arms were pooled based on dosage of GSK3326595.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Dose Modifications of GSK3326595 | Dose Interruptions | 127 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Dose Modifications of GSK3326595 | Dose Reductions | 123 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Dose Modifications of GSK3326595 | Dose Interruptions | 9 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Dose Modifications of GSK3326595 | Dose Reductions | 6 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Dose Modifications of GSK3326595 | Dose Interruptions | 27 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Dose Modifications of GSK3326595 | Dose Reductions | 11 Participants |
Secondary
RP2D Phase: Number of Participants Withdrawn Due to AEs
The data for number of participants withdrawn due to AEs have been presented.
Time frame: Up to maximum 42 months
Population: All treated population. For recommended phase 2 dose (RP2D) analysis, Part 1 and Part 2 arms were pooled based on dosage of GSK3326595.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants Withdrawn Due to AEs | 25 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants Withdrawn Due to AEs | 1 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants Withdrawn Due to AEs | 3 Participants |
Secondary
RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Baseline (Day 1) and up to maximum 42 months
Population: All treated population. For recommended phase 2 dose (RP2D) analysis, Part 1 and Part 2 arms were pooled based on dosage of GSK3326595. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 80 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 14 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 72 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 119 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 39 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 34 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 165 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 164 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 70 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 162 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 50 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 37 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 28 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 147 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 12 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 5 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 166 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 116 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 23 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 24 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 120 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 142 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 36 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 36 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 39 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 14 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 129 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 77 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 70 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 138 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 15 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 53 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 26 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 165 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 149 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 21 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 122 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 4 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 2 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 3 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 3 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 2 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 4 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 5 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 2 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 5 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 2 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 4 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 6 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 2 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 2 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 3 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, decreases to low | 14 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, changes to normal or no changes | 21 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, decreases to low | 10 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, changes to normal or no changes | 20 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, changes to normal or no changes | 21 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, changes to normal or no changes | 20 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Calcium, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alanine Aminotransferase, decreases to low | 11 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, decreases to low | 6 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, decreases to low | 13 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, increases to high | 4 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, changes to normal or no changes | 23 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, changes to normal or no changes | 21 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, increases to high | 4 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Creatinine, increases to high | 3 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Potassium, decreases to low | 6 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, decreases to low | 3 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, changes to normal or no changes | 19 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, changes to normal or no changes | 28 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, changes to normal or no changes | 27 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, decreases to low | 3 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Amylase, decreases to low | 3 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Protein, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, increases to high | 6 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Lipase, decreases to low | 3 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, changes to normal or no changes | 26 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, changes to normal or no changes | 25 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Direct Bilirubin, increases to high | 12 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Aspartate Aminotransferase, increases to high | 4 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Alkaline Phosphatase, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Sodium, decreases to low | 6 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Glucose, increases to high | 9 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, changes to normal or no changes | 24 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Albumin, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Urea Nitrogen, increases to high | 9 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters | Bilirubin, increases to high | 6 Participants |
Secondary
RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters
Blood samples were collected for evaluation of coagulation parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Baseline (Day 1) and up to maximum 42 months
Population: All treated population. For recommended phase 2 dose (RP2D) analysis, Part 1 and Part 2 arms were pooled based on dosage of GSK3326595. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 98 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 74 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 125 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 6 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 95 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 63 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 72 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 2 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 12 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 2 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 5 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 2 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 10 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 3 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, increases to high | 13 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, decreases to low | 3 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, decreases to low | 2 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Partial Thromboplastin Time, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, increases to high | 16 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Time, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Coagulation Parameters | Prothrombin Intl. Normalized Ratio, increases to high | 18 Participants |
Secondary
RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters
Blood samples were collected for evaluation of hematology parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Baseline (Day 1) and up to maximum 42 months
Population: All treated population. For recommended phase 2 dose (RP2D) analysis, Part 1 and Part 2 arms were pooled based on dosage of GSK3326595. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 104 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 51 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 136 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 110 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 64 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 108 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 22 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 92 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 3 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 91 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 22 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 93 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 106 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 18 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 94 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 183 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 30 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 173 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 86 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 115 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 8 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 12 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 59 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 14 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 5 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 38 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 173 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 97 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 129 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 13 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 79 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 31 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 94 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 170 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 3 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 7 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 9 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 10 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 4 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 5 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 3 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 6 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 3 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 3 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 6 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 6 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 2 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 5 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 3 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 5 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 7 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, decreases to low | 17 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, increases to high | 19 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, increases to high | 3 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, decreases to low | 1 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, changes to normal or no changes | 28 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, changes to normal or no changes | 8 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, changes to normal or no changes | 21 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Volume, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, increases to high | 4 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Monocytes, increases to high | 9 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, increases to high | 2 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, decreases to low | 9 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, changes to normal or no changes | 21 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, decreases to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Mean Corpuscular Hemoglobin, decreases to low | 8 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Reticulocytes, decreases to low | 9 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, decreases to low | 16 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hemoglobin, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, increases to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Neutrophils, increases to high | 6 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, decreases to low | 16 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, changes to normal or no changes | 16 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, changes to normal or no changes | 28 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Hematocrit, decreases to low | 15 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Basophils, changes to normal or no changes | 31 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Leukocytes, increases to high | 4 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, increases to high | 1 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Platelets, decreases to low | 12 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, decreases to low | 11 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Erythrocytes, changes to normal or no changes | 13 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Eosinophils, decreases to low | 3 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Hematology Parameters | Lymphocytes, changes to normal or no changes | 20 Participants |
Secondary
RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters
Urine samples were collected for evaluation of urinalysis parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v4.0. The number of participants with 'decreases to low', 'changes to normal' or 'no changes from Baseline', and 'increases to high' values have been presented.
Time frame: Baseline (Day 1) and up to maximum 42 months
Population: All treated population. For recommended phase 2 dose (RP2D) analysis, Part 1 and Part 2 arms were pooled based on dosage of GSK3326595. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 144 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 110 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 53 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 64 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 87 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 179 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 133 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 18 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 5 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 9 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 10 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 4 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 10 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 4 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 14 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, Change to Positive | 14 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, No Change or Change to Negative | 19 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Protein, Change to Positive | 12 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Ketones, No Change or Change to Negative | 17 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, Change to Positive | 8 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, No Change or Change to Negative | 25 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Glucose, Change to Positive | 6 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst Case Change From Baseline in Urinalysis Parameters | Occult Blood, No Change or Change to Negative | 23 Participants |
Secondary
RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs
Vital signs were measured. The abnormal vital sign ranges are: Heart Rate:- Low \[\<60 beats per minute (bpm)\], Normal (\>=60 bpm to \<=100 bpm), High (\>100 bpm); Temperature:- Low (\<=35 C), Normal (\>35 C and \<38 C), High (\>=38 C); Systolic Blood Pressure:- Low (\<90 mmHg), Normal (\>=90 mmHg to \<120 mmHg), High (\>=120 mmHg); Diastolic Blood Pressure:- Low (\<60 mmHg), Normal (\>=60 mmHg to \<80 mmHg), High (\>=80 mmHg). Participants were counted in the worst-case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Baseline (Day 1) and up to maximum 42 months
Population: All treated population. For recommended phase 2 dose (RP2D) analysis, Part 1 and Part 2 arms were pooled based on dosage of GSK3326595. Only those participants with data available at specified categories have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 19 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 124 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 61 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 2 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 186 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 12 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 14 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 139 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 49 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 57 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 101 Participants |
| Part 1: GSK3326595 12.5 Milligram (mg) Once a Day (QD) | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 57 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 4 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 1 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 4 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 11 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 7 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 3 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 9 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 14 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 25mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 4 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to low | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to normal or no changes | 31 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to low | 9 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Temperature, changes to high | 0 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to low | 4 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to normal or no changes | 23 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to normal or no changes | 15 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to low | 5 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to normal or no changes | 17 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Systolic Blood Pressure, changes to high | 4 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Heart Rate, changes to high | 9 Participants |
| Part 1: GSK3326595 50mg QD | RP2D Phase: Number of Participants With Worst-case Increase Post-baseline Relative to Baseline in Vital Signs | Diastolic Blood Pressure, changes to high | 9 Participants |