Hepatitis B
Conditions
Keywords
Pharmacokinetics, Safety, Pharmacodynamics, Efficacy, Chronic Hepatitis B, GSK3389404
Brief summary
GSK3389404 is being developed for the treatment of CHB virus infection. The development goal for GSK3389404 is the establishment of a finite duration treatment that results in sustained suppression of hepatitis B virus (HBV) replication and viral antigen production after cessation of all treatments for CHB due to the restoration of a functional immune response in the absence of high antigen levels. This study is a multicenter, randomized double-Blind (sponsor un-blinded in Part 1), Placebo-controlled Study which will evaluate the safety, tolerability, PK, and PD profile of GSK3389404 in subjects with CHB and aim to establish proof-of-mechanism. The study will be conducted in two parts. Part 1 plans to enroll subjects primarily from the Asia-pacific region, including Japan and will be conducted as a single ascending dose (SAD) study with 5 planned cohorts ranging from 30 milligram (mg) to a maximum of 240 mg GSK3389404. Within each cohort, subjects will be randomized to receive either GSK3389404 or placebo in a 3:1 ratio. Cohorts A, B, C, C1, and D will be conducted in a sequential fashion; Cohort C1 is an optional cohort and may be dosed after Cohort C or in parallel with Cohort D. Part 2 will be conducted as a multiple-dose, dose-ranging study. Subjects will be randomized to different parallel dose levels and regimens or placebo. The dose levels of Part 2 will be selected after a review of Part 1 safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) data. The treatments selected are 60 mg GSK3389404 weekly, 120 mg GSK3389404 bi-weekly, 120 mg GSK3389404 weekly or placebo. An optional Japanese part-2 sub-study is planned. The total study duration for part 1 including screening, treatment, and post-treatment follow-up, will not be expected to exceed 13 weeks for each subject and for part 2, including screening, treatment and post-treatment follow-up, will not be expected to exceed 65 weeks for each subject.
Interventions
DRUGGSK3389404
GSK3389404 is available as Clear colorless to slightly yellow solution for injection.
DRUGPlacebo
Placebo is available as a Clear colorless solution.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subject is able to understand and is capable of giving written informed consent, is willing to comply with protocol requirements, instructions and protocol-stated restrictions, and is likely to complete the study as planned. * Between 18 and 70 years of age, inclusive, at the time of signing the informed consent form. * A body mass index (BMI) between 18 to 30 kilogram (Kg)/meter (m\^2), inclusive. * Male or female if they satisfy the following: All females must meet the following criteria: Non-pregnant (as confirmed by a negative serum Human Chorionic Gonadotropin \[hCG\] test); AND Non-lactating at screening and prior to dosing; AND For Part 2, females of reproductive potential (FRP) must agree to follow (or confirm that they have and are currently following) one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP from at least 28 days prior to the first dose of study treatment until Follow-up visit Day 169 in conjunction with partner's use of male condom. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. For females of non-reproductive potential at least one of the following conditions must apply: Premenopausal females without reproductive potential defined by Documented salpingectomy, Hysterectomy or Documented bilateral oophorectomy; Postmenopausal defined as 12 months of spontaneous amenorrhea; A blood sample for simultaneous Follicle-Stimulating Hormone (FSH) and estradiol levels may be collected at the discretion of the investigator or site to confirm non-reproductive potential; Male subjects with a female partner of child-bearing potential must agree to meet one of the contraception requirements from the time of first dose of study treatment until Follow-up visit Day 169; Vasectomy; Male condom plus partner's use of one of the contraceptive options below that meets the Standard Operating Procedure (SOP) effectiveness criteria including a \<1 percent rate of failure per year, as stated in the product label: Contraceptive subdermal implant, Intrauterine device or intrauterine system, Combined estrogen and progestogen oral contraceptive, Injectable progestogen, Contraceptive vaginal ring, or Percutaneous contraceptive patches. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. Male subjects must refrain from donating sperm from the time of first dose of study treatment until Follow-up visit Day 169. * Documented chronic HBV infection \>=6 months prior to screening. * Subjects with HBV treatment history as follows: Part 1: Treatment naive or have had prior treatment with interferon (pegylated or non pegylated) that must have ended at least 6 months prior to the Baseline visit (Day 1 pre-dose) and/or nucleos(t)ide analogue therapy that must have ended at least 6 months prior to the Baseline visit or currently receiving stable nucleos(t)ide analogue therapy, defined as no changes to their nucleos(t)ide regimen from at least 6 months prior to screening and with no planned changes to the stable regimen over the duration of the study. Part 2: Subjects with CHB receiving stable nucleos(t)ide analogue therapy, defined as no changes to their nucleos(t)ide regimen from at least 6 months prior to screening and with no planned changes to the stable regimen over the duration of the study. Subjects with prior treatment with interferon (pegylated or non-pegylated) must have ended treatment at least 6 months prior to the Baseline visit (Day 1 pre-dose). * Plasma or serum HBV DNA concentration: treatment naïve subjects or subjects not currently receiving treatment, there is no minimum HBV DNA requirement; Subjects who are receiving stable nucleos(t)ide analogue therapy must be adequately suppressed, defined as plasma or serum HBV DNA \<lower limit of quantification (LLOQ) * Plasma or serum HBsAg concentration \>50 IU/mL. * Alanine aminotransferase (ALT) concentration: ALT \< 5 X Upper Limit of Normal (ULN) for treatment naïve subjects and for subjects who are not currently receiving treatment. ALT \<=2 times ULN for subjects who are receiving stable nucleos(t)ide analogue therapy.
Exclusion criteria
* Medical history: History of or active diagnosis of moderate to severe liver disease other than CHB, such as autoimmune hepatitis, non alcoholic steatohepatitis, hemochromatosis, or liver failure. History or other clinical evidence of significant or unstable cardiac disease (e.g., prolonged QT syndrome \[torsade de pointes\], angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease and/or clinically significant ECG abnormalities). Uncontrolled or history of difficult to control hypertension. History of, or active diagnosis of, primary or secondary renal disease (e.g., renal disease secondary to diabetes, hypertension, vascular disease, etc.). History of extrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis and polyarteritis nodosa). History of bleeding diathesis or coagulopathy. History of or suspected presence of vasculitis. History of Gilbert's Syndrome. History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (e.g., skin cancer), subjects under evaluation for possible malignancy are not eligible. * History of/sensitivity to GSK3389404 or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation. * Confirmed or suspected hepatocellular carcinoma (HCC) as evidenced by: Alpha-fetoprotein concentration \>=200 nanogram (ng)/mL. If the screening alpha-fetoprotein concentration is \>=50 ng/mL and \<200 ng/mL, the absence of liver mass must be documented by imaging within 6 months before randomization. * Liver cirrhosis or evidence of cirrhosis as determined by any of the following: Positive liver biopsy (i.e., Metavir Score F4) within 12 months of screening. Fibroscan \>12 kilopascals (kPa) within 12 months of screening. AST-Platelet Index (APRI) \>2 and FibroSure result \>0.7 within 12 months of screening and Investigator judgment. For subjects without a test for cirrhosis in the above timeframes, APRI and FibroSure should be performed during the screening period to rule out cirrhosis. * Hepatitis C Virus (HCV) co-infection. * Human Immunodeficiency Virus (HIV) co-infection. * Hepatitis D Virus (HDV) co-infection. * Laboratory results as follows: Total bilirubin concentration \>1.25 X ULN. Serum albumin concentration \<3.5 grams (g)/deciliter (dL). International normalized ratio (INR) \>1.25. Platelet count \<140 X 10\^9/L. Serum creatinine concentration greater than the ULN. Glomerular Filtration Rate (GFR) \<90 mL/min as calculated by the Chronic Kidney Disease Epidemiologic Collaboration (CKD-EPI) formula. Subjects with GFR \<90 mL/min but \>= 60 mL/min may be considered after consultation with the GlaxoSmithKline medical monitor. Urine Albumin to Creatinine Ratio (ACR)\>=0.03 mg/mg (or \>=30 mg/g). In the event of an ACR above this threshold, eligibility may be confirmed by a second measurement in cases where subjects have low urine albumin and low urine creatinine levels resulting in a urine ACR calculation \>=0.03 mg/mg (or \>=30 mg/g), the investigator should confirm that subject does not have a history of diabetes, hypertension or other risk factors that may affect renal function and discuss with the PPD or GSK medical monitor, or designee. * Positive test for blood in urine. In the event of a positive test, the test may be repeated once, and if repeat is negative or if urine microscopy reveals \<5 RBC per High-Power Field (HPF), the subject is considered eligible. * Fridericia's QT correction formula (QTcF) \>=450 milliseconds (msec) (single ECG at screening shows QTcF \>=450 msec, a mean of triplicate measurements should be used to confirm that subject meets exclusion criterion). * Currently taking, or took within 3 months of screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (\<=2 weeks) or topical/inhaled steroid use. * Current alcohol use as judged by investigator to potentially interfere with participant compliance. * A positive pre-study treatment screen and an unwillingness to refrain from use of illicit drugs (or substances with abuse potential) and adhere to other protocol-stated restrictions while participating in the study \[The screen refers to illicit drugs and substances with abuse potential. Medications that are used by the subject as directed, whether over-the-counter or through prescription, are acceptable and would not meet the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Number of Participants Achieving RR Based on Reduction of HBsAg Level From Baseline | Up to Day 85 | The RR was based on the proportion of participants with at least a 1.5 log10 IU/mL reduction of HBsAg levels from Baseline at any time up to Day 85. Number of participants who achieved \>1.5 log10 IU/mL decrease in HBsAg levels at any time up to Day 85 are presented. |
| Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30 | Electrocardiograms were obtained after 5 minutes of rest in the semi-supine or supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee. |
| Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Days 29, 57, 85 and 169 | Electrocardiogram were obtained after 5 minutes of rest in the semi-supine or supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF intervals. CS and NCS abnormal ECG findings have been presented. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee. |
| Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 450-Optional Follow-up) | Days 270, 360 and 450 | ECGs were planned to be obtained after 5 minutes of rest in the semi-supine or supine position using ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTcF intervals. |
| Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 60 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE. |
| Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis) | Up to Day 169 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE. |
| Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up) | Up to Day 450 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE. |
| Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC[0-t]) for GSK3389404 | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: AUC (0-t) for GSK3389404 | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for GSK3389404 | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | Blood samples were collected to measure AUC (0-infinity) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: AUC (0-infinity) for GSK3389404 | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | Blood samples were collected to measure AUC (0-infinity) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3389404 | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: Cmax of GSK3389404 | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Time to Achieve Cmax (Tmax) of GSK3389404 | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: Tmax of GSK3389404 | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Apparent Subcutaneous Plasma Clearance (CL/F) of GSK3389404 | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | Blood samples were collected to measure CL/F at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: CL/F of GSK3389404 | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | Blood samples were collected to measure CL/F at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Number of Participants Achieving Response Rate (RR) Based on Reduction of Hepatitis B Surface Antigen (HBsAg) Level From Baseline | Up to Day 60 | The RR was based on the proportion of participants with at least a 1.5 logarithm to the base 10 (log10) international units per milliliter (IU/mL) reduction of HBsAg levels from Baseline at any time up to Day 60. Number of participants who achieved \>1.5 log10 IU/mL decrease in HBsAg levels at any time up to Day 60 are presented. |
| Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | Baseline (Day 1 pre-dose), Day 1: 1 hour, Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30 | SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose), Day 270 and Day 450 | SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points | Baseline (Day 1 pre-dose), Days 3, 8 and 30 | Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Baseline (Day 1 pre-dose), Day 1: 1 hour, Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30 | Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose), Day 270 and Day 450 | Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose), Day 270 and Day 450 | Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Body Temperature at Indicated Time Points | Baseline (Day 1 pre-dose), Days 3, 8 and 30 | Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose), Day 270 and Day 450 | Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Number of Participants With Abnormal Findings in Physical Examination | Up to Day 60 | Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. Data was not collected and not captured in the database. |
| Part 2: Number of Participants With Abnormal Findings in Physical Examination (Up to Day 169-Interim Analysis) | Up to Day 169 | Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. Data was not collected and not captured in the database. |
| Part 2: Number of Participants With Abnormal Findings in Physical Examination (Up to Day 450-Optional Follow-up) | Up to Day 450 | Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. Data was not collected and not captured in the database. |
| Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Up to Day 60 | Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, Activated partial thromboplastin time (aPTT), Prothrombin international normalized ratio (INR) and Prothrombin time (PT). Laboratory parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented. |
| Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Up to Day 169 | Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, aPTT, Prothrombin INR and PT. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented. |
| Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Up to Day 450 | Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, aPTT, Prothrombin INR and PT. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented. |
| Part 1: Apparent Terminal Phase Half-life(t1/2) of GSK3389404 | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points | Baseline (Day 1 pre-dose) and Up to Day 60 | Blood samples were collected from participants to assess complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose) and Up to Day 169 | Blood samples were collected from participants to assess complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose) and Up to Day 450 | Blood samples were planned to be collected from participants to evaluate change from Baseline in complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Complement Bb Level at Indicated Time Points | Baseline (Day 1 pre-dose) and Up to Day 60 | Blood samples were collected from participants to assess complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose) and Up to Day 169 | Blood samples were collected from participants to assess complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose) and Up to Day 450 | Blood samples were collected from participants to evaluate change from Baseline in complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Complement C5a Level at Indicated Time Points | Baseline (Day 1 pre-dose) and Up to Day 60 | Blood samples were collected from participants to assess complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose) and Up to Day 169 | Blood samples were collected from participants to assess complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose) and Up to Day 450 | Blood samples were collected from participants to evaluate change from Baseline in complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Up to Day 60 | Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low) and Urate. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented. |
| Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Up to Day 169 | Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low), Urate and glomerular filtration rate (GFR). Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented. |
| Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Up to Day 450 | Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low), Urate and glomerular filtration rate (GFR). Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented. |
| Part 1: Change From Baseline in Urine Albumin at Indicated Time Points | Baseline (Day 1 pre-dose), Days 8, 30 and Follow-up (Day 60) | Urine samples were collected from participants to assess urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose), Days 15, 29, 43, 57, 71, 85, 92, 99, 113, 141 and 169 | Urine samples were collected from participants to assess urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose) and Up to Day 450 | Urine samples were planned to be collected from participants to evaluate change from Baseline in urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points | Baseline (Day 1 pre-dose), Days 8, 30 and Follow-up (Day 60) | Urine samples were collected from participants to assess urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose), Days 15, 29, 43, 57, 71, 85, 92, 99, 113, 141 and 169 | Urine samples were collected from participants to assess urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose) and Up to Day 450 | Urine samples were planned to be collected from participants to evaluate change from Baseline in urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60) | Urine samples were collected from participants to assess urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | Urine samples were collected from participants to assess urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose) and Up to Day 450 | Urine samples were planned to be collected from participants to evaluate change from Baseline in urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60) | Urine samples were collected from participants to assess urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | Urine samples were collected from participants to assess urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose) and Up to Day 450 | Urine samples were planned to be collected from participants to evaluate change from Baseline in urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value. |
| Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60) | Urine samples were collected from participants to assess urobilinogen levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | Urine samples were collected from participants to assess urobilinogen levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose) and Up to Day 450 | Urine samples were planned to be collected from participants to evaluate change from Baseline in urobilinogen. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value. |
| Part 2: t1/2 of GSK3389404 | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose) and Up to Day 169 | Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). |
| Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose) and Up to Day 450 | Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). |
| Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Baseline (Day 1 pre-dose) and Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60 | Blood samples were collected from participants to assess HBsAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). |
| Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | Blood samples were collected from participants to assess HBsAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). |
| Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose), Day 270, Day 360 and Day 450 | Blood samples were collected from participants to assess HBsAg level. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). |
| Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Baseline (Day 1 pre-dose) and Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60 | Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). |
| Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). |
| Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Baseline (Day 1 pre-dose), Day 270, Day 360 and Day 450 | Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). |
| Part 1: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358) | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358) | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Cmax of GSK3389404 Metabolite (ISIS 505358) | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: Cmax of GSK3389404 Metabolite (ISIS 505358) | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Tmax of GSK3389404 Metabolite (ISIS 505358) | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: Tmax of GSK3389404 Metabolite (ISIS 505358) | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: t1/2 of GSK3389404 Metabolite (ISIS 505358) | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 2: t1/2 of GSK3389404 Metabolite (ISIS 505358) | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Baseline (Day 1 pre-dose), Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60 | Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). |
Countries
China, Hong Kong, Japan, Philippines, Singapore, South Korea
Participant flow
Recruitment details
This was a Phase 2a study examining the first administration of GSK3389404 in participants with chronic hepatitis B (CHB). The study was conducted in 2 parts- Part 1 (dose escalation) and Part 2 (dose expansion and optional follow-up period).
Pre-assignment details
A total of 106 participants were screened, of which 78 participants (12 participants in Part 1 and 66 participants in Part 2) were enrolled and received either GSK3389404 or placebo. No participants were enrolled in two cohorts of Part 1 (GSK3389404 60 milligram \[mg\] and GSK3389404 240 mg) as per decision made by the dose escalation committee.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Placebo Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | 3 |
| Part 1: GSK3389404 30 mg Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | 3 |
| Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. | 6 |
| Part 2: Placebo Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | 10 |
| Part 2: GSK3389404 30 mg Weekly Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | 6 |
| Part 2: GSK3389404 60 mg Weekly Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | 20 |
| Part 2: GSK3389404 120 mg Bi-weekly Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | 15 |
| Part 2: GSK3389404 120 mg Weekly Participants received once weekly SC dose of GSK3389404 120 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | 15 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 2:Optional FU (Up to 450 Days) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Part 2:Optional FU (Up to 450 Days) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Part 2 (Up to 169 Days) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Part 2 (Up to 169 Days) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part 1: GSK3389404 30 mg | Part 1: Placebo | Part 1: GSK3389404 120 mg | Part 2: Placebo | Part 2: GSK3389404 30 mg Weekly | Part 2: GSK3389404 60 mg Weekly | Part 2: GSK3389404 120 mg Bi-weekly | Part 2: GSK3389404 120 mg Weekly |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 75 Participants | 3 Participants | 3 Participants | 6 Participants | 8 Participants | 5 Participants | 20 Participants | 15 Participants | 15 Participants |
| Race/Ethnicity, Customized Asian-East Asian Heritage | 37 Participants | 0 Participants | 1 Participants | 3 Participants | 4 Participants | 0 Participants | 9 Participants | 11 Participants | 9 Participants |
| Race/Ethnicity, Customized Asian-Japanese Heritage | 25 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 6 Participants | 7 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian-South East Asian Heritage | 15 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 0 Participants | 4 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Mixed Asian Race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 23 Participants | 0 Participants | 1 Participants | 3 Participants | 4 Participants | 1 Participants | 10 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 55 Participants | 3 Participants | 2 Participants | 3 Participants | 6 Participants | 5 Participants | 10 Participants | 13 Participants | 13 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 |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 6 | 0 / 10 | 0 / 6 | 0 / 20 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 1 / 3 | 0 / 3 | 1 / 6 | 9 / 10 | 4 / 6 | 18 / 20 | 11 / 15 | 12 / 15 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 6 | 1 / 10 | 0 / 6 | 0 / 20 | 2 / 15 | 1 / 15 |
Outcome results
Primary
Part 1: Apparent Subcutaneous Plasma Clearance (CL/F) of GSK3389404
Blood samples were collected to measure CL/F at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Apparent Subcutaneous Plasma Clearance (CL/F) of GSK3389404 | 20.6 Liters per hour |
| Part 1: GSK3389404 120 mg | Part 1: Apparent Subcutaneous Plasma Clearance (CL/F) of GSK3389404 | 7.03 Liters per hour |
Primary
Part 1: Apparent Terminal Phase Half-life(t1/2) of GSK3389404
Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Apparent Terminal Phase Half-life(t1/2) of GSK3389404 | 3.12 Hours | Geometric Coefficient of Variation 54.7 |
| Part 1: GSK3389404 120 mg | Part 1: Apparent Terminal Phase Half-life(t1/2) of GSK3389404 | 4.31 Hours | Geometric Coefficient of Variation 3.7 |
Primary
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC[0-t]) for GSK3389404
Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30
Population: Pharmacokinetic Population comprised of all participants in the Safety population for whom at least one evaluable pharmacokinetic sample were obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC[0-t]) for GSK3389404 | 1230 Hours*nanogram per milliliter | Geometric Coefficient of Variation 14.3 |
| Part 1: GSK3389404 120 mg | Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC[0-t]) for GSK3389404 | 17000 Hours*nanogram per milliliter | Geometric Coefficient of Variation 39.5 |
Primary
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for GSK3389404
Blood samples were collected to measure AUC (0-infinity) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for GSK3389404 | 1460 Hours*nanogram per milliliter | Geometric Coefficient of Variation 15.5 |
| Part 1: GSK3389404 120 mg | Part 1: Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for GSK3389404 | 17100 Hours*nanogram per milliliter | Geometric Coefficient of Variation 23.2 |
Primary
Part 1: Change From Baseline in Body Temperature at Indicated Time Points
Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 3, 8 and 30
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Body Temperature at Indicated Time Points | Day 8, n=2,3,6 | 0.20 Degrees Celsius | Standard Deviation 0.283 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Body Temperature at Indicated Time Points | Day 3, n=3,3,6 | 0.10 Degrees Celsius | Standard Deviation 0.1 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Body Temperature at Indicated Time Points | Day 30, n=3,3,6 | 0.10 Degrees Celsius | Standard Deviation 0.173 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Body Temperature at Indicated Time Points | Day 8, n=2,3,6 | -0.03 Degrees Celsius | Standard Deviation 0.351 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Body Temperature at Indicated Time Points | Day 3, n=3,3,6 | 0.37 Degrees Celsius | Standard Deviation 0.306 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Body Temperature at Indicated Time Points | Day 30, n=3,3,6 | 0.20 Degrees Celsius | Standard Deviation 0.361 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Body Temperature at Indicated Time Points | Day 3, n=3,3,6 | 0.25 Degrees Celsius | Standard Deviation 0.345 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Body Temperature at Indicated Time Points | Day 30, n=3,3,6 | 0.10 Degrees Celsius | Standard Deviation 0.358 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Body Temperature at Indicated Time Points | Day 8, n=2,3,6 | 0.08 Degrees Celsius | Standard Deviation 0.343 |
Primary
Part 1: Change From Baseline in Complement Bb Level at Indicated Time Points
Blood samples were collected from participants to assess complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 60
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Complement Bb Level at Indicated Time Points | 0.193 Milligram per liter | Standard Deviation 0.2409 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Complement Bb Level at Indicated Time Points | 0.023 Milligram per liter | Standard Deviation 0.095 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Complement Bb Level at Indicated Time Points | 0.150 Milligram per liter | Standard Deviation 0.2119 |
Primary
Part 1: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points
Blood samples were collected from participants to assess complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 60
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points | Complement C3 | -8.7 Milligram per deciliter | Standard Deviation 11.24 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points | Complement C4 | -2.0 Milligram per deciliter | Standard Deviation 2 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points | Complement C3 | -13.0 Milligram per deciliter | Standard Deviation 3 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points | Complement C4 | -2.3 Milligram per deciliter | Standard Deviation 0.58 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points | Complement C3 | -16.3 Milligram per deciliter | Standard Deviation 7.74 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points | Complement C4 | -4.2 Milligram per deciliter | Standard Deviation 3.76 |
Primary
Part 1: Change From Baseline in Complement C5a Level at Indicated Time Points
Blood samples were collected from participants to assess complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 60
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Complement C5a Level at Indicated Time Points | 1.497 Microgram per liter | Standard Deviation 0.6306 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Complement C5a Level at Indicated Time Points | 0.373 Microgram per liter | Standard Deviation 0.9952 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Complement C5a Level at Indicated Time Points | -1.267 Microgram per liter | Standard Deviation 5.7581 |
Primary
Part 1: Change From Baseline in Heart Rate at Indicated Time Points
Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Day 1: 1 hour, Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 3, n=3,3,6 | 12.11 Beats per minute | Standard Deviation 4.439 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 1: 4 hour, n=3,3,6 | 8.11 Beats per minute | Standard Deviation 3.564 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 1: 8 hour, n=3,3,6 | 5.61 Beats per minute | Standard Deviation 5.029 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 30, n=3,3,6 | 6.44 Beats per minute | Standard Deviation 16.194 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 8, n=2,3,6 | 8.00 Beats per minute | Standard Deviation 4.243 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 1: 2 hour, n=3,3,6 | 13.94 Beats per minute | Standard Deviation 12.537 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 1: 1 hour, n=3,3,6 | 4.78 Beats per minute | Standard Deviation 3.977 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 1: 4 hour, n=3,3,6 | -0.22 Beats per minute | Standard Deviation 16.201 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 1: 1 hour, n=3,3,6 | 1.44 Beats per minute | Standard Deviation 8.694 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 1: 2 hour, n=3,3,6 | 4.61 Beats per minute | Standard Deviation 17.472 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 1: 8 hour, n=3,3,6 | -5.22 Beats per minute | Standard Deviation 15.827 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 3, n=3,3,6 | 2.11 Beats per minute | Standard Deviation 3.657 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 8, n=2,3,6 | -2.89 Beats per minute | Standard Deviation 13.104 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 30, n=3,3,6 | 3.28 Beats per minute | Standard Deviation 14.958 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 3, n=3,3,6 | 2.50 Beats per minute | Standard Deviation 9.503 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 1: 1 hour, n=3,3,6 | -5.00 Beats per minute | Standard Deviation 2.53 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 30, n=3,3,6 | 1.50 Beats per minute | Standard Deviation 10.134 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 8, n=2,3,6 | 2.00 Beats per minute | Standard Deviation 10.863 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 1: 8 hour, n=3,3,6 | -0.17 Beats per minute | Standard Deviation 3.43 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 1: 2 hour, n=3,3,6 | -2.17 Beats per minute | Standard Deviation 6.338 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Day 1: 4 hour, n=3,3,6 | -0.17 Beats per minute | Standard Deviation 7.055 |
Primary
Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points
Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 3, 8 and 30
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points | Day 8, n=2,3,6 | -0.50 Breaths per minute | Standard Deviation 0.707 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points | Day 3, n=3,3,6 | -0.67 Breaths per minute | Standard Deviation 0.577 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points | Day 30, n=3,3,6 | -1.33 Breaths per minute | Standard Deviation 1.155 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points | Day 8, n=2,3,6 | -1.00 Breaths per minute | Standard Deviation 1 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points | Day 3, n=3,3,6 | -1.00 Breaths per minute | Standard Deviation 1.732 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points | Day 30, n=3,3,6 | -0.67 Breaths per minute | Standard Deviation 1.528 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points | Day 3, n=3,3,6 | -0.33 Breaths per minute | Standard Deviation 1.862 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points | Day 30, n=3,3,6 | 0.50 Breaths per minute | Standard Deviation 2.258 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points | Day 8, n=2,3,6 | 0.00 Breaths per minute | Standard Deviation 2.28 |
Primary
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Day 1: 1 hour, Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30
Population: Safety Population comprised of all participants who received at least one dose of the study treatment (including placebo). Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1: 8 hour, n=3,3,6 | -5.50 Millimeters of mercury (mmHg) | Standard Deviation 13.611 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 8, n=2,3,6 | -7.50 Millimeters of mercury (mmHg) | Standard Deviation 20.506 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1: 4 hour, n=3,3,6 | -8.50 Millimeters of mercury (mmHg) | Standard Deviation 7.365 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1: 4 hour, n=3,3,6 | -13.33 Millimeters of mercury (mmHg) | Standard Deviation 14.012 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 30, n=3,3,6 | -6.33 Millimeters of mercury (mmHg) | Standard Deviation 19.604 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1: 1 hour, n=3,3,6 | -3.67 Millimeters of mercury (mmHg) | Standard Deviation 16.073 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1: 2 hour, n=3,3,6 | -3.83 Millimeters of mercury (mmHg) | Standard Deviation 17.061 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1: 1 hour, n=3,3,6 | -0.17 Millimeters of mercury (mmHg) | Standard Deviation 4.072 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 3, n=3,3,6 | -3.00 Millimeters of mercury (mmHg) | Standard Deviation 21.633 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1: 8 hour, n=3,3,6 | -7.17 Millimeters of mercury (mmHg) | Standard Deviation 16.51 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 30, n=3,3,6 | -2.00 Millimeters of mercury (mmHg) | Standard Deviation 26.514 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1: 2 hour, n=3,3,6 | -5.33 Millimeters of mercury (mmHg) | Standard Deviation 9.018 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 3, n=3,3,6 | -7.00 Millimeters of mercury (mmHg) | Standard Deviation 20.075 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 8, n=2,3,6 | 6.00 Millimeters of mercury (mmHg) | Standard Deviation 32.527 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1: 8 hour, n=3,3,6 | 0.89 Millimeters of mercury (mmHg) | Standard Deviation 4.55 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1: 2 hour, n=3,3,6 | -3.33 Millimeters of mercury (mmHg) | Standard Deviation 3.055 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1: 1 hour, n=3,3,6 | 3.00 Millimeters of mercury (mmHg) | Standard Deviation 7.55 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1: 4 hour, n=3,3,6 | -7.67 Millimeters of mercury (mmHg) | Standard Deviation 1.528 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1: 8 hour, n=3,3,6 | -0.50 Millimeters of mercury (mmHg) | Standard Deviation 2.784 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 3, n=3,3,6 | -5.83 Millimeters of mercury (mmHg) | Standard Deviation 5.107 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 8, n=2,3,6 | -1.00 Millimeters of mercury (mmHg) | Standard Deviation 7 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 30, n=3,3,6 | -6.00 Millimeters of mercury (mmHg) | Standard Deviation 1 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1: 1 hour, n=3,3,6 | 5.72 Millimeters of mercury (mmHg) | Standard Deviation 9.595 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1: 2 hour, n=3,3,6 | 6.89 Millimeters of mercury (mmHg) | Standard Deviation 13.04 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1: 4 hour, n=3,3,6 | 0.06 Millimeters of mercury (mmHg) | Standard Deviation 6.646 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 3, n=3,3,6 | -7.94 Millimeters of mercury (mmHg) | Standard Deviation 3.084 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 8, n=2,3,6 | 4.06 Millimeters of mercury (mmHg) | Standard Deviation 5.149 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 30, n=3,3,6 | 4.89 Millimeters of mercury (mmHg) | Standard Deviation 12.303 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 8, n=2,3,6 | 0.17 Millimeters of mercury (mmHg) | Standard Deviation 4.07 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1: 4 hour, n=3,3,6 | -8.00 Millimeters of mercury (mmHg) | Standard Deviation 14.269 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 3, n=3,3,6 | -2.33 Millimeters of mercury (mmHg) | Standard Deviation 5.538 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1: 8 hour, n=3,3,6 | -3.17 Millimeters of mercury (mmHg) | Standard Deviation 7.414 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1: 8 hour, n=3,3,6 | -5.67 Millimeters of mercury (mmHg) | Standard Deviation 12.644 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1: 4 hour, n=3,3,6 | -10.50 Millimeters of mercury (mmHg) | Standard Deviation 6.626 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1: 1 hour, n=3,3,6 | 0.50 Millimeters of mercury (mmHg) | Standard Deviation 11.554 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 3, n=3,3,6 | -0.83 Millimeters of mercury (mmHg) | Standard Deviation 9.261 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 1: 2 hour, n=3,3,6 | -4.33 Millimeters of mercury (mmHg) | Standard Deviation 8.847 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1: 1 hour, n=3,3,6 | -2.33 Millimeters of mercury (mmHg) | Standard Deviation 16.367 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 30, n=3,3,6 | -3.00 Millimeters of mercury (mmHg) | Standard Deviation 10.431 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 30, n=3,3,6 | 3.67 Millimeters of mercury (mmHg) | Standard Deviation 13.736 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP, Day 1: 2 hour, n=3,3,6 | -6.00 Millimeters of mercury (mmHg) | Standard Deviation 12.083 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP, Day 8, n=2,3,6 | -1.50 Millimeters of mercury (mmHg) | Standard Deviation 9.731 |
Primary
Part 1: Change From Baseline in Urine Albumin at Indicated Time Points
Urine samples were collected from participants to assess urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 8, 30 and Follow-up (Day 60)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Albumin at Indicated Time Points | Day 8 | -0.090 Milligram per deciliter | Standard Deviation 0.1559 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Albumin at Indicated Time Points | Follow-up (Day 60) | -0.083 Milligram per deciliter | Standard Deviation 0.162 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Albumin at Indicated Time Points | Day 30 | -0.090 Milligram per deciliter | Standard Deviation 0.1559 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Albumin at Indicated Time Points | Follow-up (Day 60) | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Albumin at Indicated Time Points | Day 8 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Albumin at Indicated Time Points | Day 30 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Albumin at Indicated Time Points | Day 8 | -0.003 Milligram per deciliter | Standard Deviation 0.0082 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Albumin at Indicated Time Points | Follow-up (Day 60) | -0.003 Milligram per deciliter | Standard Deviation 0.0082 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Albumin at Indicated Time Points | Day 30 | -0.003 Milligram per deciliter | Standard Deviation 0.0082 |
Primary
Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points
Urine samples were collected from participants to assess urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 8, 30 and Follow-up (Day 60)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points | Day 30 | -4.133 Millimoles per liter | Standard Deviation 7.2947 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points | Day 8 | -6.333 Millimoles per liter | Standard Deviation 4.8003 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points | Follow-up (Day 60) | 1.800 Millimoles per liter | Standard Deviation 14.5 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points | Day 30 | -7.467 Millimoles per liter | Standard Deviation 12.1763 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points | Day 8 | -7.500 Millimoles per liter | Standard Deviation 10.8586 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points | Follow-up (Day 60) | -12.500 Millimoles per liter | Standard Deviation 12.4386 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points | Day 8 | -0.500 Millimoles per liter | Standard Deviation 5.4468 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points | Follow-up (Day 60) | -1.917 Millimoles per liter | Standard Deviation 6.3031 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points | Day 30 | -0.533 Millimoles per liter | Standard Deviation 5.5824 |
Primary
Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points
Urine samples were collected from participants to assess urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 3 | 0.333 pH | Standard Deviation 0.2887 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 8 | 0.000 pH | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 30 | 0.167 pH | Standard Deviation 0.2887 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Follow-up (Day 60) | 0.167 pH | Standard Deviation 0.2887 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 8 | 1.000 pH | Standard Deviation 0.5 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 3 | 0.167 pH | Standard Deviation 0.2887 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 30 | 0.333 pH | Standard Deviation 1.0408 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Follow-up (Day 60) | 0.500 pH | Standard Deviation 1 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 30 | 0.167 pH | Standard Deviation 0.5164 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 8 | 0.333 pH | Standard Deviation 0.6831 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Follow-up (Day 60) | 0.250 pH | Standard Deviation 0.5244 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 3 | 0.083 pH | Standard Deviation 0.4916 |
Primary
Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points
Urine samples were collected from participants to assess urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Day 3 | 0.005 Ratio | Standard Deviation 0.0091 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Day 30 | -0.001 Ratio | Standard Deviation 0.0112 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Day 8 | 0.003 Ratio | Standard Deviation 0.0081 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Follow-up (Day 60) | 0.006 Ratio | Standard Deviation 0.0125 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Day 30 | -0.013 Ratio | Standard Deviation 0.0175 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Day 8 | -0.014 Ratio | Standard Deviation 0.0151 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Day 3 | -0.011 Ratio | Standard Deviation 0.0061 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Follow-up (Day 60) | -0.014 Ratio | Standard Deviation 0.0123 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Day 30 | 0.000 Ratio | Standard Deviation 0.0066 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Day 3 | -0.001 Ratio | Standard Deviation 0.0029 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Day 8 | 0.000 Ratio | Standard Deviation 0.0087 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Follow-up (Day 60) | -0.001 Ratio | Standard Deviation 0.0079 |
Primary
Part 1: Change From Baseline in Urobilinogen at Indicated Time Points
Urine samples were collected from participants to assess urobilinogen levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Day 3 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Day 8 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Day 30 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Follow-up (Day 60) | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Day 8 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Day 3 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Follow-up (Day 60) | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Day 30 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Follow-up (Day 60) | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Day 8 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Day 30 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Day 3 | 0.000 Milligram per deciliter | Standard Deviation 0 |
Primary
Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3389404
Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3389404 | 227 Nanogram per milliliter | Geometric Coefficient of Variation 11 |
| Part 1: GSK3389404 120 mg | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3389404 | 1880 Nanogram per milliliter | Geometric Coefficient of Variation 72.4 |
Primary
Part 1: Number of Participants Achieving Response Rate (RR) Based on Reduction of Hepatitis B Surface Antigen (HBsAg) Level From Baseline
The RR was based on the proportion of participants with at least a 1.5 logarithm to the base 10 (log10) international units per milliliter (IU/mL) reduction of HBsAg levels from Baseline at any time up to Day 60. Number of participants who achieved \>1.5 log10 IU/mL decrease in HBsAg levels at any time up to Day 60 are presented.
Time frame: Up to Day 60
Population: Intent-To-Treat (ITT) Population comprised of all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants Achieving Response Rate (RR) Based on Reduction of Hepatitis B Surface Antigen (HBsAg) Level From Baseline | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants Achieving Response Rate (RR) Based on Reduction of Hepatitis B Surface Antigen (HBsAg) Level From Baseline | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants Achieving Response Rate (RR) Based on Reduction of Hepatitis B Surface Antigen (HBsAg) Level From Baseline | 0 Participants |
Primary
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Electrocardiograms were obtained after 5 minutes of rest in the semi-supine or supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.
Time frame: Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 3, n=3,3,6 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 1: 4 hour, n=3,3,6 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 1: 4 hour, n=3,3,6 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 1: 8 hour, n=3,3,6 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 1: 8 hour, n=3,3,6 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 3, n=3,3,6 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 8, n=2,3,6 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 8, n=2,3,6 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 30, n=3,3,6 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 30, n=3,3,6 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 1: 2 hour, n=3,3,6 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 1: 2 hour, n=3,3,6 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 1: 2 hour, n=3,3,6 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 30, n=3,3,6 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 1: 4 hour, n=3,3,6 | 2 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 8, n=2,3,6 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 3, n=3,3,6 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 1: 4 hour, n=3,3,6 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 1: 2 hour, n=3,3,6 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 8, n=2,3,6 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 1: 8 hour, n=3,3,6 | 2 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 3, n=3,3,6 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 30, n=3,3,6 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 1: 8 hour, n=3,3,6 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 1: 2 hour, n=3,3,6 | 5 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 3, n=3,3,6 | 3 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 30, n=3,3,6 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 3, n=3,3,6 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 8, n=2,3,6 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 8, n=2,3,6 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 1: 8 hour, n=3,3,6 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 1: 4 hour, n=3,3,6 | 3 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 30, n=3,3,6 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 1: 4 hour, n=3,3,6 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal CS, Day 1: 2 hour, n=3,3,6 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal NCS, Day 1: 8 hour, n=3,3,6 | 5 Participants |
Primary
Part 1: Number of Participants With Abnormal Findings in Physical Examination
Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. Data was not collected and not captured in the database.
Time frame: Up to Day 60
Population: Safety Population. Data was not collected and not captured in the database.
Primary
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE.
Time frame: Up to Day 60
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Primary
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters
Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low) and Urate. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.
Time frame: Up to Day 60
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Albumin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alkaline phosphatase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Phosphate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alanine aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Phosphate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alkaline phosphatase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatine kinase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatine kinase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alanine aminotransferase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatine kinase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alkaline phosphatase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatine kinase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Phosphate, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Bilirubin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatinine, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Urate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatinine, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alkaline phosphatase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatinine, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatinine, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Bilirubin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Aspartate aminotransferase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Albumin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alanine aminotransferase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Phosphate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Aspartate aminotransferase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Urate, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Albumin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Albumin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Aspartate aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Urate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Bilirubin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Magnesium, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Bilirubin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Urate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Magnesium, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Magnesium, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Aspartate aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Magnesium, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alanine aminotransferase, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Magnesium, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Phosphate, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Phosphate, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Phosphate, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Bilirubin, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Phosphate, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Albumin, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (high), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (high), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Bilirubin, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (high), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (high), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (low), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Bilirubin, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (low), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (low), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (low), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Bilirubin, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (high), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Albumin, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (high), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (high), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (high), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (high), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alanine aminotransferase, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (low), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (low), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (high), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (low), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (low), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Urate, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (high), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Urate, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Albumin, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Urate, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Urate, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (high), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (low), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (low), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alkaline phosphatase, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (low), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (low), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatine kinase, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alkaline phosphatase, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatine kinase, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alanine aminotransferase, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatine kinase, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatine kinase, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alkaline phosphatase, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatinine, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatinine, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatinine, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alkaline phosphatase, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatinine, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alanine aminotransferase, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (high), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (high), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Aspartate aminotransferase, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (high), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (high), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (low), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Aspartate aminotransferase, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (low), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (low), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (low), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Aspartate aminotransferase, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Magnesium, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alanine aminotransferase, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Magnesium, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Albumin, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Magnesium, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Aspartate aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Magnesium, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alanine aminotransferase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alanine aminotransferase, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alanine aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alanine aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Albumin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Albumin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Albumin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Albumin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alkaline phosphatase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alkaline phosphatase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alkaline phosphatase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Alkaline phosphatase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Aspartate aminotransferase, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Aspartate aminotransferase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Aspartate aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Aspartate aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Bilirubin, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Bilirubin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Bilirubin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Bilirubin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (high), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Calcium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatine kinase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatine kinase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatine kinase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatine kinase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatinine, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatinine, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatinine, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Creatinine, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (high), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Glucose (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Magnesium, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Magnesium, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Magnesium, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Phosphate, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Phosphate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Phosphate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Phosphate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Potassium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Sodium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Urate, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Urate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Urate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Urate, Grade 4 | 0 Participants |
Primary
Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters
Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, Activated partial thromboplastin time (aPTT), Prothrombin international normalized ratio (INR) and Prothrombin time (PT). Laboratory parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.
Time frame: Up to Day 60
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Lymphocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Hemoglobin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Hemoglobin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Hemoglobin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Leukocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Leukocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Leukocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Leukocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Hemoglobin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Lymphocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Lymphocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Lymphocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Neutrophil, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Neutrophil, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Neutrophil, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Neutrophil, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Platelet, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Platelet, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Platelet, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Platelet, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | aPTT, Grade 1 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | aPTT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | aPTT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | aPTT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Prothrombin INR, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Prothrombin INR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Prothrombin INR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Prothrombin INR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | PT, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | PT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | PT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | PT, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | aPTT, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Hemoglobin, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Neutrophil, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Platelet, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Hemoglobin, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Neutrophil, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | PT, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Hemoglobin, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Platelet, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | aPTT, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Hemoglobin, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | PT, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Prothrombin INR, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Leukocyte, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Platelet, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Neutrophil, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Leukocyte, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Lymphocyte, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | aPTT, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Leukocyte, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Platelet, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Prothrombin INR, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Leukocyte, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Neutrophil, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | PT, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Lymphocyte, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | aPTT, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Prothrombin INR, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Lymphocyte, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Prothrombin INR, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | PT, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Lymphocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Leukocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | PT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Lymphocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Neutrophil, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Prothrombin INR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Neutrophil, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Neutrophil, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Neutrophil, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Prothrombin INR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Platelet, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Platelet, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Platelet, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Prothrombin INR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Platelet, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | PT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | aPTT, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Hemoglobin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | aPTT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Hemoglobin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | PT, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Hemoglobin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Hemoglobin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | aPTT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Leukocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | PT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Leukocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Leukocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | aPTT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Lymphocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Lymphocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Lymphocyte, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Prothrombin INR, Grade 1 | 0 Participants |
Primary
Part 1: Time to Achieve Cmax (Tmax) of GSK3389404
Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Time to Achieve Cmax (Tmax) of GSK3389404 | 1.40 Hours |
| Part 1: GSK3389404 120 mg | Part 1: Time to Achieve Cmax (Tmax) of GSK3389404 | 3.50 Hours |
Primary
Part 2: AUC (0-infinity) for GSK3389404
Blood samples were collected to measure AUC (0-infinity) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: AUC (0-infinity) for GSK3389404 | 2030 Hours*nanogram per milliliter | Geometric Coefficient of Variation 17.7 |
| Part 1: GSK3389404 120 mg | Part 2: AUC (0-infinity) for GSK3389404 | 5990 Hours*nanogram per milliliter | Geometric Coefficient of Variation 35.3 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: AUC (0-infinity) for GSK3389404 | 12300 Hours*nanogram per milliliter | Geometric Coefficient of Variation 37.5 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: AUC (0-infinity) for GSK3389404 | 14600 Hours*nanogram per milliliter | Geometric Coefficient of Variation 47.3 |
Primary
Part 2: AUC (0-t) for GSK3389404
Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: AUC (0-t) for GSK3389404 | 1930 Hours*nanogram per milliliter | Geometric Coefficient of Variation 21.4 |
| Part 1: GSK3389404 120 mg | Part 2: AUC (0-t) for GSK3389404 | 5920 Hours*nanogram per milliliter | Geometric Coefficient of Variation 36.2 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: AUC (0-t) for GSK3389404 | 12000 Hours*nanogram per milliliter | Geometric Coefficient of Variation 38.5 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: AUC (0-t) for GSK3389404 | 14400 Hours*nanogram per milliliter | Geometric Coefficient of Variation 49.1 |
Primary
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis)
Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.06 Degrees Celsius | Standard Deviation 0.395 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 0.26 Degrees Celsius | Standard Deviation 0.599 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 0.16 Degrees Celsius | Standard Deviation 0.443 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 0.25 Degrees Celsius | Standard Deviation 0.354 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 0.14 Degrees Celsius | Standard Deviation 0.556 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 0.12 Degrees Celsius | Standard Deviation 0.592 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.01 Degrees Celsius | Standard Deviation 0.692 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | -0.11 Degrees Celsius | Standard Deviation 0.729 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | 0.10 Degrees Celsius | Standard Deviation 0.365 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 0.07 Degrees Celsius | Standard Deviation 0.581 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 0.18 Degrees Celsius | Standard Deviation 0.447 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | 0.24 Degrees Celsius | Standard Deviation 0.366 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.19 Degrees Celsius | Standard Deviation 0.716 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | 0.12 Degrees Celsius | Standard Deviation 0.609 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.14 Degrees Celsius | Standard Deviation 0.45 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | 0.03 Degrees Celsius | Standard Deviation 0.397 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.21 Degrees Celsius | Standard Deviation 0.37 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.13 Degrees Celsius | Standard Deviation 0.423 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.02 Degrees Celsius | Standard Deviation 0.366 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | -0.02 Degrees Celsius | Standard Deviation 0.366 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.25 Degrees Celsius | Standard Deviation 0.207 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | -0.03 Degrees Celsius | Standard Deviation 0.301 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.13 Degrees Celsius | Standard Deviation 0.32 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.07 Degrees Celsius | Standard Deviation 0.344 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | 0.05 Degrees Celsius | Standard Deviation 0.281 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -0.08 Degrees Celsius | Standard Deviation 0.24 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 0.15 Degrees Celsius | Standard Deviation 0.259 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 0.15 Degrees Celsius | Standard Deviation 0.266 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | -0.07 Degrees Celsius | Standard Deviation 0.28 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | 0.05 Degrees Celsius | Standard Deviation 0.243 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.08 Degrees Celsius | Standard Deviation 0.24 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | 0.07 Degrees Celsius | Standard Deviation 0.258 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | -0.12 Degrees Celsius | Standard Deviation 0.397 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | -0.13 Degrees Celsius | Standard Deviation 0.216 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.20 Degrees Celsius | Standard Deviation 0.349 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | 0.18 Degrees Celsius | Standard Deviation 0.466 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 0.07 Degrees Celsius | Standard Deviation 0.443 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.06 Degrees Celsius | Standard Deviation 0.491 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.19 Degrees Celsius | Standard Deviation 0.433 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 0.15 Degrees Celsius | Standard Deviation 0.501 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | 0.25 Degrees Celsius | Standard Deviation 0.399 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | 0.26 Degrees Celsius | Standard Deviation 0.352 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.15 Degrees Celsius | Standard Deviation 0.38 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 0.17 Degrees Celsius | Standard Deviation 0.386 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 0.26 Degrees Celsius | Standard Deviation 0.425 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.25 Degrees Celsius | Standard Deviation 0.412 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.24 Degrees Celsius | Standard Deviation 0.356 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 0.26 Degrees Celsius | Standard Deviation 0.378 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | 0.20 Degrees Celsius | Standard Deviation 0.419 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 0.14 Degrees Celsius | Standard Deviation 0.547 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 0.21 Degrees Celsius | Standard Deviation 0.494 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -0.06 Degrees Celsius | Standard Deviation 0.332 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | -0.12 Degrees Celsius | Standard Deviation 0.428 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | -0.08 Degrees Celsius | Standard Deviation 0.283 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | -0.15 Degrees Celsius | Standard Deviation 0.313 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | -0.09 Degrees Celsius | Standard Deviation 0.398 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | -0.09 Degrees Celsius | Standard Deviation 0.421 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | -0.14 Degrees Celsius | Standard Deviation 0.337 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.00 Degrees Celsius | Standard Deviation 0.43 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | -0.15 Degrees Celsius | Standard Deviation 0.385 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.13 Degrees Celsius | Standard Deviation 0.305 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.05 Degrees Celsius | Standard Deviation 0.277 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | -0.03 Degrees Celsius | Standard Deviation 0.327 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | -0.07 Degrees Celsius | Standard Deviation 0.35 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -0.02 Degrees Celsius | Standard Deviation 0.412 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | -0.04 Degrees Celsius | Standard Deviation 0.393 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.19 Degrees Celsius | Standard Deviation 0.366 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.14 Degrees Celsius | Standard Deviation 0.413 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 0.08 Degrees Celsius | Standard Deviation 0.684 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.04 Degrees Celsius | Standard Deviation 0.505 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | -0.09 Degrees Celsius | Standard Deviation 0.35 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.00 Degrees Celsius | Standard Deviation 0.679 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | -0.04 Degrees Celsius | Standard Deviation 0.557 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | -0.01 Degrees Celsius | Standard Deviation 0.536 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.03 Degrees Celsius | Standard Deviation 0.635 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 0.04 Degrees Celsius | Standard Deviation 0.612 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.04 Degrees Celsius | Standard Deviation 0.622 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | -0.10 Degrees Celsius | Standard Deviation 0.606 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | -0.07 Degrees Celsius | Standard Deviation 0.746 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | -0.11 Degrees Celsius | Standard Deviation 0.337 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | -0.10 Degrees Celsius | Standard Deviation 0.535 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.01 Degrees Celsius | Standard Deviation 0.645 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.05 Degrees Celsius | Standard Deviation 0.505 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 0.08 Degrees Celsius | Standard Deviation 0.428 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.07 Degrees Celsius | Standard Deviation 0.575 |
Primary
Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 450-Optional Follow-up)
Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Day 270 and Day 450
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 270, n=1,0,0,0,0 | -0.40 Degrees Celsius |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 450, n=0,0,1,0,0 | 0.40 Degrees Celsius |
Primary
Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 169-Interim Analysis)
Blood samples were collected from participants to assess complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 169
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 169-Interim Analysis) | 0.245 Milligram per liter | Standard Deviation 0.319 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 169-Interim Analysis) | 0.198 Milligram per liter | Standard Deviation 0.143 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 169-Interim Analysis) | 0.315 Milligram per liter | Standard Deviation 0.74 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 169-Interim Analysis) | 0.115 Milligram per liter | Standard Deviation 0.222 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 169-Interim Analysis) | -0.007 Milligram per liter | Standard Deviation 0.3 |
Primary
Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 450-Optional Follow-up)
Blood samples were collected from participants to evaluate change from Baseline in complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 450
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | 0.304 Milligram per liter | Standard Deviation 0.295 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | 0.365 Milligram per liter | Standard Deviation 0.269 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | 0.436 Milligram per liter | Standard Deviation 0.679 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | 0.173 Milligram per liter | Standard Deviation 0.213 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | 0.107 Milligram per liter | Standard Deviation 0.367 |
Primary
Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis)
Blood samples were collected from participants to assess complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 169
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Complement C3 | -11.0 Milligram per deciliter | Standard Deviation 16.1 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Complement C4 | -3.5 Milligram per deciliter | Standard Deviation 2.12 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Complement C3 | -13.5 Milligram per deciliter | Standard Deviation 9.14 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Complement C4 | -4.7 Milligram per deciliter | Standard Deviation 4.41 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Complement C3 | -11.3 Milligram per deciliter | Standard Deviation 10.38 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Complement C4 | -3.8 Milligram per deciliter | Standard Deviation 2.57 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Complement C4 | -3.4 Milligram per deciliter | Standard Deviation 2.13 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Complement C3 | -10.9 Milligram per deciliter | Standard Deviation 15.19 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Complement C3 | -17.7 Milligram per deciliter | Standard Deviation 13.98 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Complement C4 | -5.6 Milligram per deciliter | Standard Deviation 3.07 |
Primary
Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 450-Optional Follow-up)
Blood samples were planned to be collected from participants to evaluate change from Baseline in complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 450
Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
Primary
Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 169-Interim Analysis)
Blood samples were collected from participants to assess complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 169
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 169-Interim Analysis) | 1.112 Microgram per liter | Standard Deviation 1.481 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 169-Interim Analysis) | 0.860 Microgram per liter | Standard Deviation 1.625 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 169-Interim Analysis) | 1.781 Microgram per liter | Standard Deviation 2.524 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 169-Interim Analysis) | 0.353 Microgram per liter | Standard Deviation 1.323 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 169-Interim Analysis) | -0.093 Microgram per liter | Standard Deviation 1.54 |
Primary
Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 450-Optional Follow-up)
Blood samples were collected from participants to evaluate change from Baseline in complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 450
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | 1.324 Milligrams per liter | Standard Deviation 1.415 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | 2.053 Milligrams per liter | Standard Deviation 3.456 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | 2.040 Milligrams per liter | Standard Deviation 2.481 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | 0.470 Milligrams per liter | Standard Deviation 1.205 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | 0.567 Milligrams per liter | Standard Deviation 1.354 |
Primary
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | 9.9 Beats per minute | Standard Deviation 9.22 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 2.9 Beats per minute | Standard Deviation 12.78 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 3.9 Beats per minute | Standard Deviation 13.7 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 5.1 Beats per minute | Standard Deviation 13.24 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 5.7 Beats per minute | Standard Deviation 16.89 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 4.8 Beats per minute | Standard Deviation 14.3 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 6.3 Beats per minute | Standard Deviation 13.53 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | 7.5 Beats per minute | Standard Deviation 15.92 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 5.5 Beats per minute | Standard Deviation 11.32 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 7.9 Beats per minute | Standard Deviation 16.31 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 3.9 Beats per minute | Standard Deviation 11.93 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 7.8 Beats per minute | Standard Deviation 10.99 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 9.2 Beats per minute | Standard Deviation 13.89 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 6.4 Beats per minute | Standard Deviation 14.01 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | 5.1 Beats per minute | Standard Deviation 13.76 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 7.2 Beats per minute | Standard Deviation 15.3 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | 7.9 Beats per minute | Standard Deviation 12.52 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | 5.0 Beats per minute | Standard Deviation 11.03 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 6.7 Beats per minute | Standard Deviation 11.27 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -4.0 Beats per minute | Standard Deviation 11.01 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 0.8 Beats per minute | Standard Deviation 14.74 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | -3.0 Beats per minute | Standard Deviation 6.9 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -2.2 Beats per minute | Standard Deviation 9.58 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | -0.2 Beats per minute | Standard Deviation 10.38 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | -1.2 Beats per minute | Standard Deviation 9.43 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 5.7 Beats per minute | Standard Deviation 11.69 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | 6.2 Beats per minute | Standard Deviation 9.15 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 1.2 Beats per minute | Standard Deviation 8.95 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 4.7 Beats per minute | Standard Deviation 7.89 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 2.8 Beats per minute | Standard Deviation 13.04 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | 3.8 Beats per minute | Standard Deviation 9.33 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.2 Beats per minute | Standard Deviation 10.8 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | 5.3 Beats per minute | Standard Deviation 11.38 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 3.5 Beats per minute | Standard Deviation 7.92 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 5.5 Beats per minute | Standard Deviation 10.31 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | 2.8 Beats per minute | Standard Deviation 9.92 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 3.6 Beats per minute | Standard Deviation 10.64 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 3.8 Beats per minute | Standard Deviation 11.57 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 1.2 Beats per minute | Standard Deviation 10.25 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 2.1 Beats per minute | Standard Deviation 7.32 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | 2.8 Beats per minute | Standard Deviation 12.53 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | 2.6 Beats per minute | Standard Deviation 10.89 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 1.1 Beats per minute | Standard Deviation 10.19 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 3.0 Beats per minute | Standard Deviation 10.5 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 4.7 Beats per minute | Standard Deviation 12.01 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 3.6 Beats per minute | Standard Deviation 10.63 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 4.6 Beats per minute | Standard Deviation 10.23 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 4.0 Beats per minute | Standard Deviation 12.09 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | 1.5 Beats per minute | Standard Deviation 9.14 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 3.4 Beats per minute | Standard Deviation 8.32 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 4.3 Beats per minute | Standard Deviation 9.59 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 2.1 Beats per minute | Standard Deviation 8.39 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | 4.6 Beats per minute | Standard Deviation 11.47 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 2.4 Beats per minute | Standard Deviation 6.59 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | 3.0 Beats per minute | Standard Deviation 11.57 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 1.4 Beats per minute | Standard Deviation 8.04 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 4.0 Beats per minute | Standard Deviation 9.97 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 4.3 Beats per minute | Standard Deviation 10.29 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 1.8 Beats per minute | Standard Deviation 8.99 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | 5.7 Beats per minute | Standard Deviation 8.96 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 2.5 Beats per minute | Standard Deviation 8.23 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 2.6 Beats per minute | Standard Deviation 7.78 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | 3.6 Beats per minute | Standard Deviation 6.5 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 2.1 Beats per minute | Standard Deviation 6.92 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 4.7 Beats per minute | Standard Deviation 8.72 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 4.5 Beats per minute | Standard Deviation 11.35 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 5.1 Beats per minute | Standard Deviation 8.77 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 0.6 Beats per minute | Standard Deviation 9.7 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 2.5 Beats per minute | Standard Deviation 9.13 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 4.5 Beats per minute | Standard Deviation 10.59 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 1.6 Beats per minute | Standard Deviation 9.52 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 3.0 Beats per minute | Standard Deviation 7.63 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | 4.8 Beats per minute | Standard Deviation 9.92 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 1.9 Beats per minute | Standard Deviation 7.9 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 4.3 Beats per minute | Standard Deviation 10.22 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 3.1 Beats per minute | Standard Deviation 6.75 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.5 Beats per minute | Standard Deviation 9.56 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 1.5 Beats per minute | Standard Deviation 8.7 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | 1.5 Beats per minute | Standard Deviation 9.85 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | 5.2 Beats per minute | Standard Deviation 8.97 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | 4.8 Beats per minute | Standard Deviation 8.54 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.5 Beats per minute | Standard Deviation 9.23 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 1.3 Beats per minute | Standard Deviation 6.84 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 2.3 Beats per minute | Standard Deviation 9.54 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 1.1 Beats per minute | Standard Deviation 8.33 |
Primary
Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 450-Optional Follow-up)
Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Day 270 and Day 450
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 270, n=1,0,0,0,0 | -26.0 Beats per minute |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 450, n=0,0,1,0,0 | -11.0 Beats per minute |
Primary
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis)
Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 0.5 Breaths per minute | Standard Deviation 3.27 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 0.0 Breaths per minute | Standard Deviation 2.45 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -0.3 Breaths per minute | Standard Deviation 3.09 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | -0.2 Breaths per minute | Standard Deviation 2.44 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | 0.0 Breaths per minute | Standard Deviation 2.36 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | 0.7 Breaths per minute | Standard Deviation 3.09 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 0.2 Breaths per minute | Standard Deviation 2.15 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | -0.2 Breaths per minute | Standard Deviation 2.25 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | 0.00 Breaths per minute | Standard Deviation 1.94 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.4 Breaths per minute | Standard Deviation 2.01 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.4 Breaths per minute | Standard Deviation 2.63 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.2 Breaths per minute | Standard Deviation 2.78 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.1 Breaths per minute | Standard Deviation 2.77 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 0.1 Breaths per minute | Standard Deviation 2.69 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.6 Breaths per minute | Standard Deviation 2.37 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.1 Breaths per minute | Standard Deviation 2.38 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | -0.3 Breaths per minute | Standard Deviation 3.27 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.0 Breaths per minute | Standard Deviation 3.85 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | -0.8 Breaths per minute | Standard Deviation 4.49 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | -1.3 Breaths per minute | Standard Deviation 5.28 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | -1.3 Breaths per minute | Standard Deviation 5.28 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | -0.8 Breaths per minute | Standard Deviation 5 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | -0.8 Breaths per minute | Standard Deviation 5 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | -1.0 Breaths per minute | Standard Deviation 5.51 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | -0.7 Breaths per minute | Standard Deviation 4.89 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.7 Breaths per minute | Standard Deviation 4.89 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.2 Breaths per minute | Standard Deviation 3.71 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | -1.0 Breaths per minute | Standard Deviation 5.51 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | -0.8 Breaths per minute | Standard Deviation 5.19 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | -1.3 Breaths per minute | Standard Deviation 5.5 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -1.0 Breaths per minute | Standard Deviation 4.29 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | -1.0 Breaths per minute | Standard Deviation 4.9 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -1.0 Breaths per minute | Standard Deviation 4.9 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -1.0 Breaths per minute | Standard Deviation 4.9 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.5 Breaths per minute | Standard Deviation 1.64 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 0.6 Breaths per minute | Standard Deviation 1.23 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 0.4 Breaths per minute | Standard Deviation 1.1 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 0.4 Breaths per minute | Standard Deviation 1.19 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.6 Breaths per minute | Standard Deviation 1.36 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 0.2 Breaths per minute | Standard Deviation 1.24 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.5 Breaths per minute | Standard Deviation 1.5 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.3 Breaths per minute | Standard Deviation 1.63 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | -0.1 Breaths per minute | Standard Deviation 0.91 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.7 Breaths per minute | Standard Deviation 2.49 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.1 Breaths per minute | Standard Deviation 1.37 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 0.6 Breaths per minute | Standard Deviation 1.3 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.1 Breaths per minute | Standard Deviation 1.85 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | 0.3 Breaths per minute | Standard Deviation 1.38 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | 0.2 Breaths per minute | Standard Deviation 1.46 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | 0.5 Breaths per minute | Standard Deviation 1.82 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | 0.4 Breaths per minute | Standard Deviation 1.07 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.3 Breaths per minute | Standard Deviation 1.64 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | -0.3 Breaths per minute | Standard Deviation 1.27 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | -0.3 Breaths per minute | Standard Deviation 1.35 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.9 Breaths per minute | Standard Deviation 1.61 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 0.0 Breaths per minute | Standard Deviation 1.36 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | -0.3 Breaths per minute | Standard Deviation 1.27 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | -0.4 Breaths per minute | Standard Deviation 1.79 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | -0.4 Breaths per minute | Standard Deviation 1.28 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.1 Breaths per minute | Standard Deviation 1.49 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | -0.3 Breaths per minute | Standard Deviation 1.64 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | -0.1 Breaths per minute | Standard Deviation 1.44 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.2 Breaths per minute | Standard Deviation 1.42 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.0 Breaths per minute | Standard Deviation 1.04 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.2 Breaths per minute | Standard Deviation 1.31 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | -0.5 Breaths per minute | Standard Deviation 1.34 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 0.1 Breaths per minute | Standard Deviation 1.54 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | -0.7 Breaths per minute | Standard Deviation 1.49 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.1 Breaths per minute | Standard Deviation 2.03 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | -0.7 Breaths per minute | Standard Deviation 2.06 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.7 Breaths per minute | Standard Deviation 2.23 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.0 Breaths per minute | Standard Deviation 1.31 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | -0.1 Breaths per minute | Standard Deviation 1.41 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 0.2 Breaths per minute | Standard Deviation 1.9 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.3 Breaths per minute | Standard Deviation 1.29 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | -0.3 Breaths per minute | Standard Deviation 1.94 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 0.5 Breaths per minute | Standard Deviation 1.46 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.2 Breaths per minute | Standard Deviation 2.54 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 0.1 Breaths per minute | Standard Deviation 2.15 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 0.2 Breaths per minute | Standard Deviation 1.74 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | 0.1 Breaths per minute | Standard Deviation 1.39 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | -0.2 Breaths per minute | Standard Deviation 1.74 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | 0.0 Breaths per minute | Standard Deviation 1.93 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 0.4 Breaths per minute | Standard Deviation 1.5 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | -0.6 Breaths per minute | Standard Deviation 2.53 |
Primary
Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 450-Optional Follow-up)
Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Day 270 and Day 450
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 270, n=1,0,0,0,0 | 0.0 Breaths per minute |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 450, n=0,0,1,0,0 | 2.0 Breaths per minute |
Primary
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis)
SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 15, n=10,6,20,14,15 | 2.1 mmHg | Standard Deviation 8.46 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 43, n=10,6,20,14,15 | 4.2 mmHg | Standard Deviation 12.33 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 36, n=10,6,20,14,15 | 0.2 mmHg | Standard Deviation 11.43 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 113, n=10,6,20,14,15 | 5.9 mmHg | Standard Deviation 9.71 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 50, n=10,6,19,14,15 | 5.2 mmHg | Standard Deviation 14.88 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 29, n=10,6,20,13,15 | 6.1 mmHg | Standard Deviation 13.2 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 50, n=10,6,19,14,15 | 11.0 mmHg | Standard Deviation 17.26 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 8, n=10,6,20,15,15 | 7.7 mmHg | Standard Deviation 11.17 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 169, n=10,6,19,14,15 | 11.8 mmHg | Standard Deviation 12.41 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 99, n=10,6,20,14,15 | 4.3 mmHg | Standard Deviation 10.27 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 113, n=10,6,20,14,15 | 7.3 mmHg | Standard Deviation 13.3 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 57, n=10,6,20,14,15 | 4.0 mmHg | Standard Deviation 9.88 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 22, n=10,6,20,14,15 | 3.4 mmHg | Standard Deviation 9.49 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 78, n=10,6,20,14,15 | 4.6 mmHg | Standard Deviation 5.5 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 85, n=10,6,20,14,15 | 4.9 mmHg | Standard Deviation 7.2 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 99, n=10,6,20,14,15 | 7.1 mmHg | Standard Deviation 16.84 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 64, n=10,6,20,14,15 | 3.2 mmHg | Standard Deviation 9.67 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 71, n=10,6,20,14,15 | 4.6 mmHg | Standard Deviation 11.98 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 8, n=10,6,20,15,15 | 5.8 mmHg | Standard Deviation 8.9 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 71, n=10,6,20,14,15 | 2.9 mmHg | Standard Deviation 9.56 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 57, n=10,6,20,14,15 | 1.7 mmHg | Standard Deviation 13.86 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 22, n=10,6,20,14,15 | 5.7 mmHg | Standard Deviation 13.72 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 169, n=10,6,19,14,15 | 5.8 mmHg | Standard Deviation 10.13 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 29, n=10,6,20,13,15 | 3.9 mmHg | Standard Deviation 8.77 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 15, n=10,6,20,14,15 | 8.0 mmHg | Standard Deviation 11.6 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 64, n=10,6,20,14,15 | 5.1 mmHg | Standard Deviation 11.98 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 43, n=10,6,20,14,15 | 5.6 mmHg | Standard Deviation 9.91 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 141, n=10,6,20,14,15 | 7.5 mmHg | Standard Deviation 10.2 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 78, n=10,6,20,14,15 | 5.2 mmHg | Standard Deviation 12.28 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 141, n=10,6,20,14,15 | 10.9 mmHg | Standard Deviation 11.51 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 36, n=10,6,20,14,15 | 1.8 mmHg | Standard Deviation 8.9 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 85, n=10,6,20,14,15 | 7.2 mmHg | Standard Deviation 15.22 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 92, n=10,6,19,14,15 | 5.0 mmHg | Standard Deviation 12.57 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 92, n=10,6,19,14,15 | 2.9 mmHg | Standard Deviation 7.39 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 78, n=10,6,20,14,15 | 5.0 mmHg | Standard Deviation 6.16 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 29, n=10,6,20,13,15 | 1.7 mmHg | Standard Deviation 4.27 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 22, n=10,6,20,14,15 | -2.0 mmHg | Standard Deviation 6.2 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 36, n=10,6,20,14,15 | -0.5 mmHg | Standard Deviation 12.05 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 43, n=10,6,20,14,15 | 4.7 mmHg | Standard Deviation 13.22 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 71, n=10,6,20,14,15 | 5.0 mmHg | Standard Deviation 10.22 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 50, n=10,6,19,14,15 | 4.7 mmHg | Standard Deviation 9.65 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 141, n=10,6,20,14,15 | 3.5 mmHg | Standard Deviation 9.81 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 57, n=10,6,20,14,15 | 2.5 mmHg | Standard Deviation 13.4 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 64, n=10,6,20,14,15 | 0.2 mmHg | Standard Deviation 9.11 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 29, n=10,6,20,13,15 | 3.3 mmHg | Standard Deviation 2.25 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 92, n=10,6,19,14,15 | 3.8 mmHg | Standard Deviation 7.63 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 36, n=10,6,20,14,15 | -1.7 mmHg | Standard Deviation 9.35 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 169, n=10,6,19,14,15 | 9.7 mmHg | Standard Deviation 12.45 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 43, n=10,6,20,14,15 | 0.0 mmHg | Standard Deviation 6.45 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 99, n=10,6,20,14,15 | 3.0 mmHg | Standard Deviation 9.86 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 113, n=10,6,20,14,15 | 5.7 mmHg | Standard Deviation 9.35 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 50, n=10,6,19,14,15 | 2.8 mmHg | Standard Deviation 8.93 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 57, n=10,6,20,14,15 | -0.2 mmHg | Standard Deviation 8.73 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 64, n=10,6,20,14,15 | 0.3 mmHg | Standard Deviation 9.31 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 71, n=10,6,20,14,15 | 3.8 mmHg | Standard Deviation 7.11 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 99, n=10,6,20,14,15 | 3.3 mmHg | Standard Deviation 15.45 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 8, n=10,6,20,15,15 | 2.3 mmHg | Standard Deviation 8.71 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 85, n=10,6,20,14,15 | 1.0 mmHg | Standard Deviation 9.47 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 92, n=10,6,19,14,15 | 4.3 mmHg | Standard Deviation 8.5 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 113, n=10,6,20,14,15 | 2.7 mmHg | Standard Deviation 8.8 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 141, n=10,6,20,14,15 | 1.2 mmHg | Standard Deviation 8.33 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 15, n=10,6,20,14,15 | -4.0 mmHg | Standard Deviation 13.02 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 169, n=10,6,19,14,15 | 6.3 mmHg | Standard Deviation 11.71 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 85, n=10,6,20,14,15 | 5.2 mmHg | Standard Deviation 9.06 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 8, n=10,6,20,15,15 | 5.0 mmHg | Standard Deviation 7.4 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 78, n=10,6,20,14,15 | 1.2 mmHg | Standard Deviation 6.59 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 15, n=10,6,20,14,15 | 1.7 mmHg | Standard Deviation 14.42 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 22, n=10,6,20,14,15 | 1.5 mmHg | Standard Deviation 6.57 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 64, n=10,6,20,14,15 | -4.1 mmHg | Standard Deviation 9.17 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 99, n=10,6,20,14,15 | 0.3 mmHg | Standard Deviation 10.8 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 50, n=10,6,19,14,15 | 0.1 mmHg | Standard Deviation 9.95 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 71, n=10,6,20,14,15 | -2.2 mmHg | Standard Deviation 11.97 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 43, n=10,6,20,14,15 | -0.3 mmHg | Standard Deviation 12.38 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 36, n=10,6,20,14,15 | -5.6 mmHg | Standard Deviation 10.54 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 113, n=10,6,20,14,15 | -1.2 mmHg | Standard Deviation 10.96 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 113, n=10,6,20,14,15 | -3.2 mmHg | Standard Deviation 11.64 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 36, n=10,6,20,14,15 | -0.8 mmHg | Standard Deviation 8.84 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 29, n=10,6,20,13,15 | -1.7 mmHg | Standard Deviation 8.55 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 15, n=10,6,20,14,15 | -0.4 mmHg | Standard Deviation 10.02 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 141, n=10,6,20,14,15 | 0.7 mmHg | Standard Deviation 12.37 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 141, n=10,6,20,14,15 | -0.9 mmHg | Standard Deviation 12.77 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 85, n=10,6,20,14,15 | -5.0 mmHg | Standard Deviation 12.73 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 57, n=10,6,20,14,15 | -4.2 mmHg | Standard Deviation 10.21 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 78, n=10,6,20,14,15 | -4.4 mmHg | Standard Deviation 10.09 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 169, n=10,6,19,14,15 | 0.5 mmHg | Standard Deviation 11.14 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 15, n=10,6,20,14,15 | -0.3 mmHg | Standard Deviation 9.09 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 22, n=10,6,20,14,15 | 0.3 mmHg | Standard Deviation 8.77 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 50, n=10,6,19,14,15 | -3.4 mmHg | Standard Deviation 11.93 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 29, n=10,6,20,13,15 | -3.1 mmHg | Standard Deviation 11.83 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 71, n=10,6,20,14,15 | -0.6 mmHg | Standard Deviation 9.83 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 64, n=10,6,20,14,15 | -1.9 mmHg | Standard Deviation 10.27 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 8, n=10,6,20,15,15 | -2.6 mmHg | Standard Deviation 10.45 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 78, n=10,6,20,14,15 | -0.8 mmHg | Standard Deviation 8.8 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 22, n=10,6,20,14,15 | -2.2 mmHg | Standard Deviation 8.66 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 99, n=10,6,20,14,15 | -0.5 mmHg | Standard Deviation 14.05 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 169, n=10,6,19,14,15 | 0.8 mmHg | Standard Deviation 11.61 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 43, n=10,6,20,14,15 | -0.6 mmHg | Standard Deviation 11.89 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 85, n=10,6,20,14,15 | -1.2 mmHg | Standard Deviation 12.35 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 8, n=10,6,20,15,15 | -1.9 mmHg | Standard Deviation 7.13 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 92, n=10,6,19,14,15 | -4.1 mmHg | Standard Deviation 12.6 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 92, n=10,6,19,14,15 | -2.2 mmHg | Standard Deviation 9.52 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 57, n=10,6,20,14,15 | -0.5 mmHg | Standard Deviation 9.1 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 92, n=10,6,19,14,15 | 4.6 mmHg | Standard Deviation 13.87 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 64, n=10,6,20,14,15 | 1.4 mmHg | Standard Deviation 16.29 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 8, n=10,6,20,15,15 | 1.0 mmHg | Standard Deviation 8.86 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 15, n=10,6,20,14,15 | -0.3 mmHg | Standard Deviation 7.09 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 22, n=10,6,20,14,15 | 1.6 mmHg | Standard Deviation 9.8 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 29, n=10,6,20,13,15 | 2.1 mmHg | Standard Deviation 9.71 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 36, n=10,6,20,14,15 | 1.9 mmHg | Standard Deviation 8.46 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 43, n=10,6,20,14,15 | 0.9 mmHg | Standard Deviation 10.99 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 50, n=10,6,19,14,15 | 1.3 mmHg | Standard Deviation 10.25 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 57, n=10,6,20,14,15 | 1.6 mmHg | Standard Deviation 8.34 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 71, n=10,6,20,14,15 | 3.1 mmHg | Standard Deviation 9.92 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 78, n=10,6,20,14,15 | 5.0 mmHg | Standard Deviation 8.71 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 85, n=10,6,20,14,15 | 6.4 mmHg | Standard Deviation 11.21 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 92, n=10,6,19,14,15 | 3.9 mmHg | Standard Deviation 9.08 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 99, n=10,6,20,14,15 | 1.3 mmHg | Standard Deviation 10.38 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 113, n=10,6,20,14,15 | 4.9 mmHg | Standard Deviation 8.28 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 141, n=10,6,20,14,15 | 0.8 mmHg | Standard Deviation 8.51 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 169, n=10,6,19,14,15 | 3.4 mmHg | Standard Deviation 12.07 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 8, n=10,6,20,15,15 | 0.8 mmHg | Standard Deviation 14.35 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 15, n=10,6,20,14,15 | 2.1 mmHg | Standard Deviation 12.77 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 22, n=10,6,20,14,15 | 2.4 mmHg | Standard Deviation 11.54 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 29, n=10,6,20,13,15 | 2.9 mmHg | Standard Deviation 16.89 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 36, n=10,6,20,14,15 | 0.4 mmHg | Standard Deviation 16.21 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 43, n=10,6,20,14,15 | 1.7 mmHg | Standard Deviation 16.11 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 50, n=10,6,19,14,15 | 1.6 mmHg | Standard Deviation 12.74 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 57, n=10,6,20,14,15 | 0.1 mmHg | Standard Deviation 14.91 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 71, n=10,6,20,14,15 | 4.8 mmHg | Standard Deviation 17.68 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 78, n=10,6,20,14,15 | 4.1 mmHg | Standard Deviation 13.95 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 85, n=10,6,20,14,15 | 6.2 mmHg | Standard Deviation 15.62 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 64, n=10,6,20,14,15 | 2.1 mmHg | Standard Deviation 9.71 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 99, n=10,6,20,14,15 | 1.6 mmHg | Standard Deviation 16.46 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 113, n=10,6,20,14,15 | 4.9 mmHg | Standard Deviation 12.07 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 141, n=10,6,20,14,15 | 2.9 mmHg | Standard Deviation 15.93 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 169, n=10,6,19,14,15 | 5.1 mmHg | Standard Deviation 17.41 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 22, n=10,6,20,14,15 | -2.1 mmHg | Standard Deviation 14.36 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 15, n=10,6,20,14,15 | 0.1 mmHg | Standard Deviation 11.03 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 169, n=10,6,19,14,15 | 4.9 mmHg | Standard Deviation 12.85 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 78, n=10,6,20,14,15 | -0.1 mmHg | Standard Deviation 12.99 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 8, n=10,6,20,15,15 | 2.1 mmHg | Standard Deviation 9.59 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 169, n=10,6,19,14,15 | -0.3 mmHg | Standard Deviation 8.83 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 141, n=10,6,20,14,15 | 1.1 mmHg | Standard Deviation 11.28 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 141, n=10,6,20,14,15 | 4.6 mmHg | Standard Deviation 16.85 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 85, n=10,6,20,14,15 | -3.5 mmHg | Standard Deviation 14.3 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 113, n=10,6,20,14,15 | 2.9 mmHg | Standard Deviation 8.17 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 99, n=10,6,20,14,15 | 0.1 mmHg | Standard Deviation 10.8 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 85, n=10,6,20,14,15 | -2.3 mmHg | Standard Deviation 10.69 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 8, n=10,6,20,15,15 | -0.7 mmHg | Standard Deviation 8.61 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 92, n=10,6,19,14,15 | -0.1 mmHg | Standard Deviation 12.14 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 78, n=10,6,20,14,15 | -4.2 mmHg | Standard Deviation 9.85 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 71, n=10,6,20,14,15 | 1.4 mmHg | Standard Deviation 9.74 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 57, n=10,6,20,14,15 | -0.8 mmHg | Standard Deviation 8.16 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 92, n=10,6,19,14,15 | -1.1 mmHg | Standard Deviation 10 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 99, n=10,6,20,14,15 | 2.2 mmHg | Standard Deviation 16.34 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 50, n=10,6,19,14,15 | -3.2 mmHg | Standard Deviation 7.74 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 43, n=10,6,20,14,15 | -0.8 mmHg | Standard Deviation 6.12 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 36, n=10,6,20,14,15 | -0.1 mmHg | Standard Deviation 6.38 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 64, n=10,6,20,14,15 | -1.8 mmHg | Standard Deviation 9.93 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 113, n=10,6,20,14,15 | 6.6 mmHg | Standard Deviation 10.72 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 29, n=10,6,20,13,15 | -0.7 mmHg | Standard Deviation 7.35 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 22, n=10,6,20,14,15 | -3.0 mmHg | Standard Deviation 9.13 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 57, n=10,6,20,14,15 | 0.9 mmHg | Standard Deviation 17.26 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 64, n=10,6,20,14,15 | 0.5 mmHg | Standard Deviation 15.5 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 50, n=10,6,19,14,15 | -2.2 mmHg | Standard Deviation 11.36 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 43, n=10,6,20,14,15 | 0.0 mmHg | Standard Deviation 12.53 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 36, n=10,6,20,14,15 | 2.1 mmHg | Standard Deviation 12.9 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | DBP, Day 15, n=10,6,20,14,15 | -2.7 mmHg | Standard Deviation 7.32 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 71, n=10,6,20,14,15 | 4.2 mmHg | Standard Deviation 12.46 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP, Day 29, n=10,6,20,13,15 | 1.5 mmHg | Standard Deviation 10.29 |
Primary
Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 450-Optional Follow-up)
SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Day 270 and Day 450
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 450-Optional Follow-up) | DBP, Day 270, n=1,0,0,0,0 | -9.0 mmHg |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 450-Optional Follow-up) | SBP, Day 270, n=1,0,0,0,0 | -18.0 mmHg |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 450-Optional Follow-up) | DBP, Day 450, n=0,0,1,0,0 | 7.0 mmHg |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 450-Optional Follow-up) | SBP, Day 450, n=0,0,1,0,0 | 3.0 mmHg |
Primary
Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis)
Urine samples were collected from participants to assess urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 15, 29, 43, 57, 71, 85, 92, 99, 113, 141 and 169
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.386 Milligram per deciliter | Standard Deviation 1.4751 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | -0.076 Milligram per deciliter | Standard Deviation 0.2267 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.068 Milligram per deciliter | Standard Deviation 0.215 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,14 | 0.484 Milligram per deciliter | Standard Deviation 1.5305 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.038 Milligram per deciliter | Standard Deviation 0.1202 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -0.068 Milligram per deciliter | Standard Deviation 0.215 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -0.068 Milligram per deciliter | Standard Deviation 0.215 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.068 Milligram per deciliter | Standard Deviation 0.215 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.068 Milligram per deciliter | Standard Deviation 0.215 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | -0.068 Milligram per deciliter | Standard Deviation 0.215 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,19,13,15 | -0.020 Milligram per deciliter | Standard Deviation 0.2766 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 0.223 Milligram per deciliter | Standard Deviation 0.5471 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.088 Milligram per deciliter | Standard Deviation 0.1613 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,19,13,15 | 0.057 Milligram per deciliter | Standard Deviation 0.1388 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 0.147 Milligram per deciliter | Standard Deviation 0.3593 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | 0.027 Milligram per deciliter | Standard Deviation 0.0653 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.260 Milligram per deciliter | Standard Deviation 0.6369 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.252 Milligram per deciliter | Standard Deviation 0.6165 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,14 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | 0.047 Milligram per deciliter | Standard Deviation 0.2247 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.157 Milligram per deciliter | Standard Deviation 0.6699 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 0.067 Milligram per deciliter | Standard Deviation 0.2858 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.105 Milligram per deciliter | Standard Deviation 0.3408 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.031 Milligram per deciliter | Standard Deviation 0.1811 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 0.287 Milligram per deciliter | Standard Deviation 1.1198 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,19,13,15 | 0.376 Milligram per deciliter | Standard Deviation 1.1353 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 0.436 Milligram per deciliter | Standard Deviation 1.3939 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,14 | 0.004 Milligram per deciliter | Standard Deviation 0.0157 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.102 Milligram per deciliter | Standard Deviation 0.4265 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 0.061 Milligram per deciliter | Standard Deviation 0.235 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.108 Milligram per deciliter | Standard Deviation 0.4036 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,14 | -0.044 Milligram per deciliter | Standard Deviation 0.3593 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | 1.356 Milligram per deciliter | Standard Deviation 5.1498 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 7.142 Milligram per deciliter | Standard Deviation 27.161 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.100 Milligram per deciliter | Standard Deviation 0.4276 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -0.095 Milligram per deciliter | Standard Deviation 0.3555 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | -0.034 Milligram per deciliter | Standard Deviation 0.1256 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 0.014 Milligram per deciliter | Standard Deviation 0.3879 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.028 Milligram per deciliter | Standard Deviation 0.4733 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,19,13,15 | -0.060 Milligram per deciliter | Standard Deviation 0.4801 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | -0.028 Milligram per deciliter | Standard Deviation 0.5206 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | -0.249 Milligram per deciliter | Standard Deviation 1.2805 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,19,13,15 | -0.342 Milligram per deciliter | Standard Deviation 1.2507 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.276 Milligram per deciliter | Standard Deviation 1.2739 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -0.345 Milligram per deciliter | Standard Deviation 1.2457 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -0.317 Milligram per deciliter | Standard Deviation 1.2678 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.317 Milligram per deciliter | Standard Deviation 1.2571 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,14 | 0.054 Milligram per deciliter | Standard Deviation 2.1129 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | -0.263 Milligram per deciliter | Standard Deviation 1.2876 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.293 Milligram per deciliter | Standard Deviation 1.271 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | -0.113 Milligram per deciliter | Standard Deviation 1.6274 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.307 Milligram per deciliter | Standard Deviation 1.2558 |
Primary
Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 450-Optional Follow-up)
Urine samples were planned to be collected from participants to evaluate change from Baseline in urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 450
Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
Primary
Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis)
Urine samples were collected from participants to assess urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 15, 29, 43, 57, 71, 85, 92, 99, 113, 141 and 169
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | -0.380 Millimoles per liter | Standard Deviation 5.2742 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.730 Millimoles per liter | Standard Deviation 6.3381 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.420 Millimoles per liter | Standard Deviation 8.0098 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 1.900 Millimoles per liter | Standard Deviation 6.0566 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -3.440 Millimoles per liter | Standard Deviation 8.1759 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -1.520 Millimoles per liter | Standard Deviation 6.5367 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,14 | 1.250 Millimoles per liter | Standard Deviation 3.9769 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.250 Millimoles per liter | Standard Deviation 8.1437 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | -1.989 Millimoles per liter | Standard Deviation 7.6522 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 1.180 Millimoles per liter | Standard Deviation 6.5445 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,19,13,15 | 1.640 Millimoles per liter | Standard Deviation 12.4484 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 2.150 Millimoles per liter | Standard Deviation 2.6251 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 4.283 Millimoles per liter | Standard Deviation 6.9975 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | 1.933 Millimoles per liter | Standard Deviation 3.4518 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -1.183 Millimoles per liter | Standard Deviation 2.2516 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 3.367 Millimoles per liter | Standard Deviation 4.6224 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,14 | 3.100 Millimoles per liter | Standard Deviation 7.2812 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,19,13,15 | -0.200 Millimoles per liter | Standard Deviation 1.9819 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.150 Millimoles per liter | Standard Deviation 4.7218 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | -0.350 Millimoles per liter | Standard Deviation 3.1507 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 3.383 Millimoles per liter | Standard Deviation 4.1427 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.833 Millimoles per liter | Standard Deviation 2.75 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 1.335 Millimoles per liter | Standard Deviation 6.3596 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 1.353 Millimoles per liter | Standard Deviation 5.67 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,19,13,15 | 0.395 Millimoles per liter | Standard Deviation 4.2339 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 1.090 Millimoles per liter | Standard Deviation 4.9374 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 2.484 Millimoles per liter | Standard Deviation 5.4097 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 1.775 Millimoles per liter | Standard Deviation 4.6852 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 1.645 Millimoles per liter | Standard Deviation 4.254 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | -0.615 Millimoles per liter | Standard Deviation 3.4238 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 1.625 Millimoles per liter | Standard Deviation 7.437 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,14 | 1.620 Millimoles per liter | Standard Deviation 5.9265 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -0.005 Millimoles per liter | Standard Deviation 4.1111 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | -0.679 Millimoles per liter | Standard Deviation 8.1936 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,14 | 0.621 Millimoles per liter | Standard Deviation 6.6401 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -2.571 Millimoles per liter | Standard Deviation 5.5116 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | -1.500 Millimoles per liter | Standard Deviation 7.3661 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,19,13,15 | -0.515 Millimoles per liter | Standard Deviation 8.9447 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 0.386 Millimoles per liter | Standard Deviation 7.7418 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -1.593 Millimoles per liter | Standard Deviation 7.3409 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | -1.614 Millimoles per liter | Standard Deviation 8.1636 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -2.336 Millimoles per liter | Standard Deviation 7.3438 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.185 Millimoles per liter | Standard Deviation 6.7815 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 0.464 Millimoles per liter | Standard Deviation 7.7548 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.307 Millimoles per liter | Standard Deviation 6.2369 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -0.707 Millimoles per liter | Standard Deviation 5.137 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | -0.160 Millimoles per liter | Standard Deviation 5.5418 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.713 Millimoles per liter | Standard Deviation 5.9545 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.560 Millimoles per liter | Standard Deviation 4.855 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.127 Millimoles per liter | Standard Deviation 5.1497 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,19,13,15 | -1.273 Millimoles per liter | Standard Deviation 4.9312 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,14 | 1.129 Millimoles per liter | Standard Deviation 7.8266 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | -1.013 Millimoles per liter | Standard Deviation 5.4487 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -2.980 Millimoles per liter | Standard Deviation 5.0428 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 0.020 Millimoles per liter | Standard Deviation 5.187 |
Primary
Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 450-Optional Follow-up)
Urine samples were planned to be collected from participants to evaluate change from Baseline in urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 450
Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
Primary
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis)
Urine samples were collected from participants to assess urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,19,13,14 | 0.100 pH | Standard Deviation 0.5676 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,19,13,14 | 0.111 pH | Standard Deviation 0.7817 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,19,13,14 | 0.200 pH | Standard Deviation 0.6325 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,19,13,14 | 0.200 pH | Standard Deviation 0.6325 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,19,13,14 | 0.100 pH | Standard Deviation 0.9944 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,18,13,14 | 0.000 pH | Standard Deviation 0.7071 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,19,13,14 | 0.300 pH | Standard Deviation 0.6749 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,18,13,14 | -0.200 pH | Standard Deviation 0.7888 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,14,13 | 0.300 pH | Standard Deviation 0.9487 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,17,12,14 | 0.000 pH | Standard Deviation 0.8165 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=9,6,19,13,14 | 0.333 pH | Standard Deviation 0.7071 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,19,13,14 | 0.200 pH | Standard Deviation 0.7888 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,19,13,14 | 0.100 pH | Standard Deviation 0.5676 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,19,13,14 | 0.050 pH | Standard Deviation 0.896 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,19,12,14 | 0.200 pH | Standard Deviation 0.6325 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,18,13,14 | 0.000 pH | Standard Deviation 0.8165 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,19,13,14 | 0.000 pH | Standard Deviation 1.0541 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,17,12,14 | 0.000 pH | Standard Deviation 0.6325 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,14,13 | -0.333 pH | Standard Deviation 0.8165 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,19,13,14 | -0.500 pH | Standard Deviation 1.0488 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=9,6,19,13,14 | -0.667 pH | Standard Deviation 0.5164 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,19,13,14 | -0.333 pH | Standard Deviation 1.0328 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,19,13,14 | -0.167 pH | Standard Deviation 0.7528 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,18,13,14 | -0.167 pH | Standard Deviation 1.169 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,19,13,14 | -0.167 pH | Standard Deviation 0.7528 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,19,13,14 | 0.000 pH | Standard Deviation 0.6325 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,18,13,14 | 0.167 pH | Standard Deviation 0.4082 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,19,13,14 | 0.167 pH | Standard Deviation 0.9832 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,18,13,14 | 0.000 pH | Standard Deviation 0.6325 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,19,12,14 | -0.167 pH | Standard Deviation 0.7528 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,19,13,14 | -0.167 pH | Standard Deviation 0.7528 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,19,13,14 | -0.167 pH | Standard Deviation 0.7528 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,19,13,14 | 0.000 pH | Standard Deviation 0.8944 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,19,13,14 | 0.167 pH | Standard Deviation 0.7528 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,19,13,14 | 0.000 pH | Standard Deviation 0.4714 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,19,13,14 | 0.000 pH | Standard Deviation 0.5774 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,19,13,14 | 0.053 pH | Standard Deviation 0.6213 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,19,12,14 | 0.000 pH | Standard Deviation 0.4714 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,19,13,14 | -0.026 pH | Standard Deviation 0.6341 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,17,12,14 | -0.176 pH | Standard Deviation 0.5286 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,18,13,14 | -0.278 pH | Standard Deviation 0.4609 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,19,13,14 | -0.105 pH | Standard Deviation 0.4588 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,19,13,14 | -0.105 pH | Standard Deviation 0.6578 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,18,13,14 | 0.056 pH | Standard Deviation 0.5393 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,19,13,14 | -0.053 pH | Standard Deviation 0.5243 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,18,13,14 | 0.000 pH | Standard Deviation 0.5941 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=9,6,19,13,14 | -0.211 pH | Standard Deviation 0.7133 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,14,13 | -0.132 pH | Standard Deviation 0.704 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,19,13,14 | -0.158 pH | Standard Deviation 0.5015 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,19,13,14 | 0.000 pH | Standard Deviation 0.4714 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,19,13,14 | -0.105 pH | Standard Deviation 0.6578 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,19,13,14 | -0.077 pH | Standard Deviation 0.6405 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,19,13,14 | 0.000 pH | Standard Deviation 0.7071 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,19,13,14 | 0.000 pH | Standard Deviation 0.5774 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,18,13,14 | 0.000 pH | Standard Deviation 0.7071 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,19,13,14 | -0.154 pH | Standard Deviation 0.9871 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,19,13,14 | -0.154 pH | Standard Deviation 0.6887 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,19,13,14 | -0.077 pH | Standard Deviation 0.6405 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,18,13,14 | 0.077 pH | Standard Deviation 0.6405 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=9,6,19,13,14 | -0.308 pH | Standard Deviation 0.6304 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,17,12,14 | 0.000 pH | Standard Deviation 0.9535 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,19,12,14 | 0.000 pH | Standard Deviation 0.7385 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,19,13,14 | 0.077 pH | Standard Deviation 0.7596 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,19,13,14 | 0.000 pH | Standard Deviation 0.5774 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,14,13 | -0.071 pH | Standard Deviation 0.4746 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,18,13,14 | -0.231 pH | Standard Deviation 0.725 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,19,13,14 | 0.077 pH | Standard Deviation 0.8623 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,19,13,14 | 0.077 pH | Standard Deviation 0.6405 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,19,13,14 | -0.107 pH | Standard Deviation 0.7888 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,17,12,14 | -0.143 pH | Standard Deviation 0.9493 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,19,13,14 | -0.214 pH | Standard Deviation 0.5789 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,19,13,14 | -0.071 pH | Standard Deviation 0.73 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,19,13,14 | -0.214 pH | Standard Deviation 0.5789 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,19,13,14 | -0.071 pH | Standard Deviation 0.4746 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,19,13,14 | -0.214 pH | Standard Deviation 0.6993 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,19,13,14 | -0.214 pH | Standard Deviation 0.5789 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,18,13,14 | -0.071 pH | Standard Deviation 0.4746 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,18,13,14 | -0.214 pH | Standard Deviation 0.6993 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=9,6,19,13,14 | -0.143 pH | Standard Deviation 1.0271 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,14,13 | -0.077 pH | Standard Deviation 0.6405 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,19,13,14 | 0.143 pH | Standard Deviation 0.7703 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,19,13,14 | -0.143 pH | Standard Deviation 0.7703 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,18,13,14 | 0.036 pH | Standard Deviation 0.8872 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,19,12,14 | -0.286 pH | Standard Deviation 0.6112 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,19,13,14 | 0.000 pH | Standard Deviation 0.5547 |
Primary
Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 450-Optional Follow-up)
Urine samples were planned to be collected from participants to evaluate change from Baseline in urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 450
Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
Primary
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis)
Urine samples were collected from participants to assess urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,15,14 | -0.001 Ratio | Standard Deviation 0.008 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | -0.001 Ratio | Standard Deviation 0.0082 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 0.004 Ratio | Standard Deviation 0.01 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -0.001 Ratio | Standard Deviation 0.0072 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.0082 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.001 Ratio | Standard Deviation 0.01 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.001 Ratio | Standard Deviation 0.0098 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | -0.002 Ratio | Standard Deviation 0.0103 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 0.002 Ratio | Standard Deviation 0.0054 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 0.002 Ratio | Standard Deviation 0.0081 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | -0.002 Ratio | Standard Deviation 0.0069 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.001 Ratio | Standard Deviation 0.0074 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,18,13,15 | 0.000 Ratio | Standard Deviation 0.0101 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | -0.003 Ratio | Standard Deviation 0.0098 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,19,14,15 | -0.003 Ratio | Standard Deviation 0.0081 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.001 Ratio | Standard Deviation 0.007 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.003 Ratio | Standard Deviation 0.0107 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.002 Ratio | Standard Deviation 0.0051 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.001 Ratio | Standard Deviation 0.0068 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,19,14,15 | 0.002 Ratio | Standard Deviation 0.0079 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | 0.002 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 0.002 Ratio | Standard Deviation 0.0053 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.001 Ratio | Standard Deviation 0.006 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.002 Ratio | Standard Deviation 0.0022 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,15,14 | 0.004 Ratio | Standard Deviation 0.0049 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 0.003 Ratio | Standard Deviation 0.0093 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 0.004 Ratio | Standard Deviation 0.0085 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.005 Ratio | Standard Deviation 0.0078 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 0.002 Ratio | Standard Deviation 0.0067 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.001 Ratio | Standard Deviation 0.0039 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 0.003 Ratio | Standard Deviation 0.0052 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.003 Ratio | Standard Deviation 0.0045 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,18,13,15 | 0.000 Ratio | Standard Deviation 0.0043 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | -0.002 Ratio | Standard Deviation 0.0023 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.001 Ratio | Standard Deviation 0.0063 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | -0.001 Ratio | Standard Deviation 0.0073 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.001 Ratio | Standard Deviation 0.0052 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -0.001 Ratio | Standard Deviation 0.0044 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | -0.002 Ratio | Standard Deviation 0.0065 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,19,14,15 | -0.002 Ratio | Standard Deviation 0.0065 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 0.001 Ratio | Standard Deviation 0.005 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.0057 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.0055 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,18,13,15 | 0.000 Ratio | Standard Deviation 0.0054 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 0.001 Ratio | Standard Deviation 0.0072 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 0.001 Ratio | Standard Deviation 0.0058 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 0.001 Ratio | Standard Deviation 0.0056 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.0078 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 0.001 Ratio | Standard Deviation 0.0047 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.005 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,15,14 | -0.001 Ratio | Standard Deviation 0.006 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.001 Ratio | Standard Deviation 0.0063 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.000 Ratio | Standard Deviation 0.0051 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | -0.001 Ratio | Standard Deviation 0.007 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,19,14,15 | -0.001 Ratio | Standard Deviation 0.0095 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | -0.001 Ratio | Standard Deviation 0.0059 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.003 Ratio | Standard Deviation 0.0059 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | -0.003 Ratio | Standard Deviation 0.0074 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.0086 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | 0.000 Ratio | Standard Deviation 0.0077 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,15,14 | 0.000 Ratio | Standard Deviation 0.0055 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.0083 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | -0.001 Ratio | Standard Deviation 0.0067 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -0.003 Ratio | Standard Deviation 0.0073 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | -0.004 Ratio | Standard Deviation 0.0085 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | -0.002 Ratio | Standard Deviation 0.0079 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.002 Ratio | Standard Deviation 0.0061 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,18,13,15 | -0.001 Ratio | Standard Deviation 0.009 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -0.003 Ratio | Standard Deviation 0.0052 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.0066 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | -0.003 Ratio | Standard Deviation 0.0082 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | -0.001 Ratio | Standard Deviation 0.0081 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.0058 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.007 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.000 Ratio | Standard Deviation 0.0058 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | 0.001 Ratio | Standard Deviation 0.0053 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 0.001 Ratio | Standard Deviation 0.0052 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,19,14,15 | 0.000 Ratio | Standard Deviation 0.0076 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,18,13,15 | -0.001 Ratio | Standard Deviation 0.0047 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.0048 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.001 Ratio | Standard Deviation 0.0064 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.0064 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.0069 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 0.000 Ratio | Standard Deviation 0.0088 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,15,14 | 0.000 Ratio | Standard Deviation 0.0063 |
Primary
Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 450-Optional Follow-up)
Urine samples were planned to be collected from participants to evaluate change from Baseline in urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 450
Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
Primary
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis)
Urine samples were collected from participants to assess urobilinogen levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,17,13,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,19,14,15 | 0.180 Milligram per deciliter | Standard Deviation 0.5692 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 0.180 Milligram per deciliter | Standard Deviation 0.5692 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,14 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,15,14 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,14 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,14 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,17,13,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,14 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,15,14 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | 0.180 Milligram per deciliter | Standard Deviation 0.554 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 0.180 Milligram per deciliter | Standard Deviation 0.554 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.189 Milligram per deciliter | Standard Deviation 0.5675 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,17,13,15 | 0.106 Milligram per deciliter | Standard Deviation 0.4366 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,19,14,15 | 0.095 Milligram per deciliter | Standard Deviation 0.4129 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,14 | 0.095 Milligram per deciliter | Standard Deviation 0.4129 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,15,14 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 0.090 Milligram per deciliter | Standard Deviation 0.4025 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.090 Milligram per deciliter | Standard Deviation 0.4025 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.180 Milligram per deciliter | Standard Deviation 0.554 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,14 | 0.090 Milligram per deciliter | Standard Deviation 0.4025 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,15,14 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,14 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,17,13,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,14 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,14 | 0.129 Milligram per deciliter | Standard Deviation 0.4811 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=10,6,20,14,14 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,19,14,15 | 0.240 Milligram per deciliter | Standard Deviation 0.6334 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | 0.120 Milligram per deciliter | Standard Deviation 0.4648 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,19,14,15 | 0.120 Milligram per deciliter | Standard Deviation 0.4648 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=9,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,19,15,14 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | 0.240 Milligram per deciliter | Standard Deviation 0.6334 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=9,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | 0.120 Milligram per deciliter | Standard Deviation 0.4648 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,17,13,15 | 0.000 Milligram per deciliter | Standard Deviation 0 |
Primary
Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 450-Optional Follow-up)
Urine samples were planned to be collected from participants to evaluate change from Baseline in urobilinogen. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 pre-dose) and Up to Day 450
Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
Primary
Part 2: CL/F of GSK3389404
Blood samples were collected to measure CL/F at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: CL/F of GSK3389404 | 14.8 Liters per hour |
| Part 1: GSK3389404 120 mg | Part 2: CL/F of GSK3389404 | 10.0 Liters per hour |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: CL/F of GSK3389404 | 9.75 Liters per hour |
| Part 2: GSK3389404 120 mg Weekly | Part 2: CL/F of GSK3389404 | 8.23 Liters per hour |
Primary
Part 2: Cmax of GSK3389404
Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Cmax of GSK3389404 | 214 Nanogram per milliliter | Geometric Coefficient of Variation 54.3 |
| Part 1: GSK3389404 120 mg | Part 2: Cmax of GSK3389404 | 865 Nanogram per milliliter | Geometric Coefficient of Variation 41.3 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Cmax of GSK3389404 | 1660 Nanogram per milliliter | Geometric Coefficient of Variation 34.4 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Cmax of GSK3389404 | 1940 Nanogram per milliliter | Geometric Coefficient of Variation 78.2 |
Primary
Part 2: Number of Participants Achieving RR Based on Reduction of HBsAg Level From Baseline
The RR was based on the proportion of participants with at least a 1.5 log10 IU/mL reduction of HBsAg levels from Baseline at any time up to Day 85. Number of participants who achieved \>1.5 log10 IU/mL decrease in HBsAg levels at any time up to Day 85 are presented.
Time frame: Up to Day 85
Population: ITT Population. Data is presented only for interim analysis; since this analysis was not planned for optional follow-up period (up to Day 450).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants Achieving RR Based on Reduction of HBsAg Level From Baseline | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants Achieving RR Based on Reduction of HBsAg Level From Baseline | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants Achieving RR Based on Reduction of HBsAg Level From Baseline | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants Achieving RR Based on Reduction of HBsAg Level From Baseline | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants Achieving RR Based on Reduction of HBsAg Level From Baseline | 1 Participants |
Primary
Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis)
Electrocardiogram were obtained after 5 minutes of rest in the semi-supine or supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF intervals. CS and NCS abnormal ECG findings have been presented. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.
Time frame: Days 29, 57, 85 and 169
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 169, NCS, n=10,6,19,14,15 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 57, NCS, n=10,6,20,14,15 | 5 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 29, CS, n=10,6,20,13,15 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 85, CS, n=10,6,20,14,15 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 85, NCS, n=10,6,20,14,15 | 3 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 169, CS, n=10,6,19,14,15 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 57, CS, n=10,6,20,14,15 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 29, NCS, n=10,6,20,13,15 | 2 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 169, CS, n=10,6,19,14,15 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 57, NCS, n=10,6,20,14,15 | 3 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 29, CS, n=10,6,20,13,15 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 85, CS, n=10,6,20,14,15 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 29, NCS, n=10,6,20,13,15 | 2 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 85, NCS, n=10,6,20,14,15 | 3 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 169, NCS, n=10,6,19,14,15 | 2 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 57, CS, n=10,6,20,14,15 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 57, CS, n=10,6,20,14,15 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 29, NCS, n=10,6,20,13,15 | 6 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 57, NCS, n=10,6,20,14,15 | 6 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 169, NCS, n=10,6,19,14,15 | 4 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 29, CS, n=10,6,20,13,15 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 169, CS, n=10,6,19,14,15 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 85, NCS, n=10,6,20,14,15 | 4 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 85, CS, n=10,6,20,14,15 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 169, NCS, n=10,6,19,14,15 | 5 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 29, NCS, n=10,6,20,13,15 | 6 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 29, CS, n=10,6,20,13,15 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 57, CS, n=10,6,20,14,15 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 85, NCS, n=10,6,20,14,15 | 4 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 169, CS, n=10,6,19,14,15 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 57, NCS, n=10,6,20,14,15 | 3 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 85, CS, n=10,6,20,14,15 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 169, CS, n=10,6,19,14,15 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 169, NCS, n=10,6,19,14,15 | 5 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 85, NCS, n=10,6,20,14,15 | 4 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 57, CS, n=10,6,20,14,15 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 29, CS, n=10,6,20,13,15 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 29, NCS, n=10,6,20,13,15 | 5 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 85, CS, n=10,6,20,14,15 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Day 57, NCS, n=10,6,20,14,15 | 6 Participants |
Primary
Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 450-Optional Follow-up)
ECGs were planned to be obtained after 5 minutes of rest in the semi-supine or supine position using ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTcF intervals.
Time frame: Days 270, 360 and 450
Population: Safety Population. Data was not collected for this outcome measure during optional follow-up period.
Primary
Part 2: Number of Participants With Abnormal Findings in Physical Examination (Up to Day 169-Interim Analysis)
Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. Data was not collected and not captured in the database.
Time frame: Up to Day 169
Population: Safety Population. Data was not collected and not captured in the database.
Primary
Part 2: Number of Participants With Abnormal Findings in Physical Examination (Up to Day 450-Optional Follow-up)
Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. Data was not collected and not captured in the database.
Time frame: Up to Day 450
Population: Safety Population. Data was not collected and not captured in the database.
Primary
Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE.
Time frame: Up to Day 169
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis) | SAEs | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis) | AEs | 9 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis) | SAEs | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis) | AEs | 4 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis) | AEs | 16 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis) | SAEs | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis) | SAEs | 2 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis) | AEs | 11 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis) | AEs | 12 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis) | SAEs | 0 Participants |
Primary
Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE.
Time frame: Up to Day 450
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up) | AEs | 9 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up) | SAEs | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up) | SAEs | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up) | AEs | 4 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up) | SAEs | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up) | AEs | 18 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up) | AEs | 11 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up) | SAEs | 2 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up) | SAEs | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up) | AEs | 12 Participants |
Primary
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis)
Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low), Urate and glomerular filtration rate (GFR). Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.
Time frame: Up to Day 169
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 2 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 1 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 2 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 2 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 1 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 1 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 4 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 1 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 3 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 1 | 3 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 1 | 6 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 2 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 1 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 3 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 1 | 5 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 2 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 1 | 10 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 3 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 3 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 1 | 6 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 2 | 3 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 3 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 1 | 8 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 3 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 1 | 7 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 1 | 5 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 3 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatinine, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Sodium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 1 | 3 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Bilirubin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Urate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 1 | 4 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alanine aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Creatine kinase, Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Albumin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Potassium (high), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Alkaline phosphatase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | GFR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Magnesium, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Calcium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 1 | 4 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 3 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Aspartate aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Phosphate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Glucose (high), Grade 2 | 3 Participants |
Primary
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up)
Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low), Urate and glomerular filtration rate (GFR). Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.
Time frame: Up to Day 450
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 1 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 2 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 1 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 4 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 2 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 1 | 3 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 2 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 1 | 6 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 1 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 1 | 2 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 1 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 2 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 3 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 2 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 1 | 5 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 3 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 1 | 3 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 3 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 1 | 11 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 3 | 2 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 1 | 8 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 3 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 1 | 6 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 2 | 3 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 3 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | GFR, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Bilirubin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 1 | 3 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 3 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 1 | 7 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 2 | 3 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 3 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (high), Grade 1 | 6 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Magnesium, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Sodium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Urate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Glucose (low), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatine kinase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Albumin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Creatinine, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Potassium (high), Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alkaline phosphatase, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Calcium (low), Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Alanine aminotransferase, Grade 1 | 4 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Phosphate, Grade 1 | 4 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Aspartate aminotransferase, Grade 3 | 0 Participants |
Primary
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis)
Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, aPTT, Prothrombin INR and PT. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.
Time frame: Up to Day 169
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 1 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 1 | 2 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 1 | 6 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 1 | 5 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 1 | 3 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 1 | 4 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 1 | 5 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Leukocyte, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Hemoglobin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 3 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | PT, Grade 1 | 5 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | aPTT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Platelet, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 1 | 3 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Prothrombin INR, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Neutrophil, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Lymphocyte, Grade 2 | 0 Participants |
Primary
Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up)
Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, aPTT, Prothrombin INR and PT. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.
Time frame: Up to Day 450
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 1 | 1 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 3 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 2 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 1 | 2 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 1 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 4 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 1 | 1 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 2 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 3 | 0 Participants |
| Part 1: GSK3389404 120 mg | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 1 | 5 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 1 | 6 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 1 | 3 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 1 | 4 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 3 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 1 | 2 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 1 | 5 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 1 | 5 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Leukocyte, Grade 1 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Prothrombin INR, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 2 | 1 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 2 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Hemoglobin, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | PT, Grade 4 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Lymphocyte, Grade 1 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Platelet, Grade 3 | 0 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Neutrophil, Grade 1 | 3 Participants |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | aPTT, Grade 4 | 0 Participants |
Primary
Part 2: t1/2 of GSK3389404
Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: t1/2 of GSK3389404 | 3.90 Hours | Geometric Coefficient of Variation 55 |
| Part 1: GSK3389404 120 mg | Part 2: t1/2 of GSK3389404 | 3.24 Hours | Geometric Coefficient of Variation 26 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: t1/2 of GSK3389404 | 4.24 Hours | Geometric Coefficient of Variation 29.5 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: t1/2 of GSK3389404 | 2.89 Hours | Geometric Coefficient of Variation 48.4 |
Primary
Part 2: Tmax of GSK3389404
Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Tmax of GSK3389404 | 2.04 Hours |
| Part 1: GSK3389404 120 mg | Part 2: Tmax of GSK3389404 | 3.46 Hours |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Tmax of GSK3389404 | 4.05 Hours |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Tmax of GSK3389404 | 4.02 Hours |
Secondary
Part 1: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358)
Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358) | NA Hours*nanogram per milliliter | — |
| Part 1: GSK3389404 120 mg | Part 1: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358) | 44.2 Hours*nanogram per milliliter | Geometric Coefficient of Variation 419.1 |
Secondary
Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points
Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Time frame: Baseline (Day 1 pre-dose) and Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60
Population: Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 3, n=3,3,4 | -0.01 Log10 (IU/mL) | Standard Deviation 0.02 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 22, n=3,3,4 | 0.03 Log10 (IU/mL) | Standard Deviation 0.052 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 15, n=3,3,4 | 0.02 Log10 (IU/mL) | Standard Deviation 0.036 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 1: 8 hour, n=3,3,5 | 0.15 Log10 (IU/mL) | Standard Deviation 0.237 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 60, n=3,3,4 | 0.00 Log10 (IU/mL) | Standard Deviation 0 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 30, n=3,3,4 | 0.22 Log10 (IU/mL) | Standard Deviation 0.331 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 8, n=3,3,4 | 0.02 Log10 (IU/mL) | Standard Deviation 0.036 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 15, n=3,3,4 | -0.01 Log10 (IU/mL) | Standard Deviation 0.025 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 1: 8 hour, n=3,3,5 | -0.03 Log10 (IU/mL) | Standard Deviation 0.053 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 3, n=3,3,4 | -0.02 Log10 (IU/mL) | Standard Deviation 0.039 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 8, n=3,3,4 | 0.03 Log10 (IU/mL) | Standard Deviation 0.044 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 22, n=3,3,4 | 0.01 Log10 (IU/mL) | Standard Deviation 0.012 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 30, n=3,3,4 | -0.02 Log10 (IU/mL) | Standard Deviation 0.039 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 60, n=3,3,4 | 0.00 Log10 (IU/mL) | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 22, n=3,3,4 | 0.08 Log10 (IU/mL) | Standard Deviation 0.151 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 3, n=3,3,4 | 0.00 Log10 (IU/mL) | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 60, n=3,3,4 | 0.00 Log10 (IU/mL) | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 30, n=3,3,4 | 0.17 Log10 (IU/mL) | Standard Deviation 0.342 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 15, n=3,3,4 | 0.00 Log10 (IU/mL) | Standard Deviation 0 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 8, n=3,3,4 | 0.94 Log10 (IU/mL) | Standard Deviation 1.885 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Day 1: 8 hour, n=3,3,5 | 0.00 Log10 (IU/mL) | Standard Deviation 0 |
Secondary
Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points
Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Time frame: Baseline (Day 1 pre-dose), Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60
Population: Pharmacodynamic Population comprised of all participants in the Safety Population who provided evaluable pharmacodynamic data. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 1: 8 hour, n=2,3,5 | -0.19 Log10 (IU/mL) | Standard Deviation 0.202 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 60, n=2,3,6 | -0.30 Log10 (IU/mL) | Standard Deviation 0.292 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 15, n=2,3,6 | 0.17 Log10 (IU/mL) | Standard Deviation 0.173 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 30, n=2,3,6 | -0.12 Log10 (IU/mL) | Standard Deviation 0.077 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 3, n=2,3,6 | -0.06 Log10 (IU/mL) | Standard Deviation 0.065 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 22, n=2,3,6 | 0.16 Log10 (IU/mL) | Standard Deviation 0.224 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 8, n=2,3,6 | 0.06 Log10 (IU/mL) | Standard Deviation 0.265 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 22, n=2,3,6 | -0.07 Log10 (IU/mL) | Standard Deviation 0.114 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 30, n=2,3,6 | 0.34 Log10 (IU/mL) | Standard Deviation 0.821 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 60, n=2,3,6 | -0.04 Log10 (IU/mL) | Standard Deviation 0.075 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 8, n=2,3,6 | 0.37 Log10 (IU/mL) | Standard Deviation 0.788 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 1: 8 hour, n=2,3,5 | -0.03 Log10 (IU/mL) | Standard Deviation 0.055 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 15, n=2,3,6 | -0.05 Log10 (IU/mL) | Standard Deviation 0.086 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 3, n=2,3,6 | 0.41 Log10 (IU/mL) | Standard Deviation 0.754 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 60, n=2,3,6 | 0.12 Log10 (IU/mL) | Standard Deviation 0.199 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 3, n=2,3,6 | 0.20 Log10 (IU/mL) | Standard Deviation 0.539 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 8, n=2,3,6 | -0.02 Log10 (IU/mL) | Standard Deviation 0.075 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 15, n=2,3,6 | -0.17 Log10 (IU/mL) | Standard Deviation 0.317 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 22, n=2,3,6 | -0.09 Log10 (IU/mL) | Standard Deviation 0.165 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 30, n=2,3,6 | 0.13 Log10 (IU/mL) | Standard Deviation 0.573 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Day 1: 8 hour, n=2,3,5 | 0.50 Log10 (IU/mL) | Standard Deviation 0.716 |
Secondary
Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points
Blood samples were collected from participants to assess HBsAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Time frame: Baseline (Day 1 pre-dose) and Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60
Population: Pharmacodynamic Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 60 | -0.00 Log10 (IU/mL) | Standard Deviation 0.064 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 8 | -0.01 Log10 (IU/mL) | Standard Deviation 0.078 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 30 | -0.01 Log10 (IU/mL) | Standard Deviation 0.038 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 1: 8 hour | -0.03 Log10 (IU/mL) | Standard Deviation 0.027 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 15 | 0.00 Log10 (IU/mL) | Standard Deviation 0.066 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 3 | 0.01 Log10 (IU/mL) | Standard Deviation 0.016 |
| Part 2: GSK3389404 30 mg Weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 22 | 0.03 Log10 (IU/mL) | Standard Deviation 0.052 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 1: 8 hour | 0.02 Log10 (IU/mL) | Standard Deviation 0.023 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 22 | -0.04 Log10 (IU/mL) | Standard Deviation 0.066 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 30 | -0.02 Log10 (IU/mL) | Standard Deviation 0.021 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 60 | 0.01 Log10 (IU/mL) | Standard Deviation 0.057 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 3 | 0.00 Log10 (IU/mL) | Standard Deviation 0.014 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 8 | 0.01 Log10 (IU/mL) | Standard Deviation 0.051 |
| Part 1: GSK3389404 120 mg | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 15 | -0.02 Log10 (IU/mL) | Standard Deviation 0.043 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 60 | -0.05 Log10 (IU/mL) | Standard Deviation 0.038 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 22 | -0.14 Log10 (IU/mL) | Standard Deviation 0.114 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 1: 8 hour | -0.02 Log10 (IU/mL) | Standard Deviation 0.032 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 8 | -0.09 Log10 (IU/mL) | Standard Deviation 0.079 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 15 | -0.10 Log10 (IU/mL) | Standard Deviation 0.075 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 30 | -0.12 Log10 (IU/mL) | Standard Deviation 0.139 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Day 3 | -0.05 Log10 (IU/mL) | Standard Deviation 0.038 |
Secondary
Part 1: Cmax of GSK3389404 Metabolite (ISIS 505358)
Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3389404 120 mg | Part 1: Cmax of GSK3389404 Metabolite (ISIS 505358) | 2.93 Nanogram per milliliter | Geometric Coefficient of Variation 60.1 |
Secondary
Part 1: t1/2 of GSK3389404 Metabolite (ISIS 505358)
Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1: GSK3389404 120 mg | Part 1: t1/2 of GSK3389404 Metabolite (ISIS 505358) | 18.75 Hours |
Secondary
Part 1: Tmax of GSK3389404 Metabolite (ISIS 505358)
Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3389404 120 mg | Part 1: Tmax of GSK3389404 Metabolite (ISIS 505358) | 7.88 Hours |
Secondary
Part 2: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358)
Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3389404 120 mg | Part 2: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358) | NA Hours*nanogram per milliliter | — |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358) | NA Hours*nanogram per milliliter | — |
| Part 2: GSK3389404 120 mg Weekly | Part 2: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358) | 17.1 Hours*nanogram per milliliter | Geometric Coefficient of Variation 169.7 |
Secondary
Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up)
Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Time frame: Baseline (Day 1 pre-dose), Day 270, Day 360 and Day 450
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 360, n=7,5,11,9,9 | -0.153 Log10 (IU/mL) | Standard Deviation 0.3744 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 270, n=7,5,11,10,9 | 0.050 Log10 (IU/mL) | Standard Deviation 0.1771 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 450, n=6,5,12,8,9 | 0.000 Log10 (IU/mL) | Standard Deviation 0 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 360, n=7,5,11,9,9 | -0.122 Log10 (IU/mL) | Standard Deviation 0.2189 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 270, n=7,5,11,10,9 | -0.028 Log10 (IU/mL) | Standard Deviation 0.3263 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 450, n=6,5,12,8,9 | -0.119 Log10 (IU/mL) | Standard Deviation 0.1866 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 450, n=6,5,12,8,9 | -0.088 Log10 (IU/mL) | Standard Deviation 0.2225 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 270, n=7,5,11,10,9 | -0.120 Log10 (IU/mL) | Standard Deviation 0.3325 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 360, n=7,5,11,9,9 | -0.084 Log10 (IU/mL) | Standard Deviation 0.2531 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 450, n=6,5,12,8,9 | -0.155 Log10 (IU/mL) | Standard Deviation 0.2663 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 360, n=7,5,11,9,9 | -0.035 Log10 (IU/mL) | Standard Deviation 0.0689 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 270, n=7,5,11,10,9 | -0.041 Log10 (IU/mL) | Standard Deviation 0.067 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 360, n=7,5,11,9,9 | -0.003 Log10 (IU/mL) | Standard Deviation 0.1408 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 450, n=6,5,12,8,9 | -0.035 Log10 (IU/mL) | Standard Deviation 0.0627 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 270, n=7,5,11,10,9 | 0.014 Log10 (IU/mL) | Standard Deviation 0.0877 |
Secondary
Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Time frame: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=7,6,13,10,9 | 0.002 Log10 (IU/mL) | Standard Deviation 0.0111 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=7,6,12,10,9 | 0.007 Log10 (IU/mL) | Standard Deviation 0.0186 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=7,6,13,10,9 | 0.101 Log10 (IU/mL) | Standard Deviation 0.2223 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=7,6,13,10,9 | 0.050 Log10 (IU/mL) | Standard Deviation 0.0937 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=7,6,12,10,9 | 0.120 Log10 (IU/mL) | Standard Deviation 0.2791 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=7,6,13,11,9 | 0.008 Log10 (IU/mL) | Standard Deviation 0.0215 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=7,6,13,10,9 | -0.025 Log10 (IU/mL) | Standard Deviation 0.1243 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=7,6,13,10,9 | 0.061 Log10 (IU/mL) | Standard Deviation 0.1113 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=7,6,13,10,9 | 0.008 Log10 (IU/mL) | Standard Deviation 0.0397 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=6,6,13,10,8 | 0.018 Log10 (IU/mL) | Standard Deviation 0.0438 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=7,6,12,10,9 | -0.027 Log10 (IU/mL) | Standard Deviation 0.1334 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=7,6,12,10,9 | -0.019 Log10 (IU/mL) | Standard Deviation 0.1253 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=7,6,13,10,9 | 0.015 Log10 (IU/mL) | Standard Deviation 0.0628 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=7,6,12,9,9 | 0.093 Log10 (IU/mL) | Standard Deviation 0.1966 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=7,6,15,11,10 | 0.039 Log10 (IU/mL) | Standard Deviation 0.075 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=7,6,13,10,9 | 0.209 Log10 (IU/mL) | Standard Deviation 0.4253 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=7,6,13,10,9 | 0.008 Log10 (IU/mL) | Standard Deviation 0.0139 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=7,6,13,10,9 | -0.030 Log10 (IU/mL) | Standard Deviation 0.0516 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=7,6,13,10,9 | 0.003 Log10 (IU/mL) | Standard Deviation 0.0552 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=7,6,13,10,9 | -0.006 Log10 (IU/mL) | Standard Deviation 0.0603 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=7,6,12,10,9 | 0.086 Log10 (IU/mL) | Standard Deviation 0.2363 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=7,6,13,10,9 | -0.003 Log10 (IU/mL) | Standard Deviation 0.0666 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=7,6,15,11,10 | 0.023 Log10 (IU/mL) | Standard Deviation 0.0565 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=7,6,13,11,9 | -0.008 Log10 (IU/mL) | Standard Deviation 0.0203 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=7,6,12,10,9 | -0.028 Log10 (IU/mL) | Standard Deviation 0.0695 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=7,6,12,10,9 | -0.012 Log10 (IU/mL) | Standard Deviation 0.0574 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=7,6,13,10,9 | -0.024 Log10 (IU/mL) | Standard Deviation 0.0592 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=7,6,13,10,9 | 0.018 Log10 (IU/mL) | Standard Deviation 0.1297 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=7,6,13,10,9 | 0.001 Log10 (IU/mL) | Standard Deviation 0.0457 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=6,6,13,10,8 | 0.059 Log10 (IU/mL) | Standard Deviation 0.1518 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=7,6,12,10,9 | -0.004 Log10 (IU/mL) | Standard Deviation 0.0551 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=7,6,13,10,9 | 0.010 Log10 (IU/mL) | Standard Deviation 0.0624 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=7,6,13,10,9 | 0.017 Log10 (IU/mL) | Standard Deviation 0.1427 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=7,6,12,9,9 | 0.004 Log10 (IU/mL) | Standard Deviation 0.0398 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=7,6,13,10,9 | -0.040 Log10 (IU/mL) | Standard Deviation 0.0773 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=7,6,13,10,9 | -0.040 Log10 (IU/mL) | Standard Deviation 0.1006 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=7,6,13,10,9 | -0.110 Log10 (IU/mL) | Standard Deviation 0.1288 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=7,6,15,11,10 | 0.010 Log10 (IU/mL) | Standard Deviation 0.0555 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=7,6,13,10,9 | -0.120 Log10 (IU/mL) | Standard Deviation 0.1296 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=7,6,13,10,9 | -0.111 Log10 (IU/mL) | Standard Deviation 0.1141 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=7,6,12,10,9 | -0.100 Log10 (IU/mL) | Standard Deviation 0.1224 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=7,6,13,10,9 | -0.113 Log10 (IU/mL) | Standard Deviation 0.1285 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=6,6,13,10,8 | -0.101 Log10 (IU/mL) | Standard Deviation 0.1161 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=7,6,12,10,9 | -0.089 Log10 (IU/mL) | Standard Deviation 0.0944 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=7,6,12,9,9 | -0.099 Log10 (IU/mL) | Standard Deviation 0.2382 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=7,6,13,10,9 | -0.080 Log10 (IU/mL) | Standard Deviation 0.0946 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=7,6,12,10,9 | -0.129 Log10 (IU/mL) | Standard Deviation 0.204 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=7,6,13,11,9 | -0.054 Log10 (IU/mL) | Standard Deviation 0.0732 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=7,6,13,10,9 | -0.049 Log10 (IU/mL) | Standard Deviation 0.1086 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=7,6,13,10,9 | -0.020 Log10 (IU/mL) | Standard Deviation 0.0519 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=7,6,12,10,9 | -0.091 Log10 (IU/mL) | Standard Deviation 0.1283 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=7,6,13,10,9 | -0.073 Log10 (IU/mL) | Standard Deviation 0.1216 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=7,6,13,10,9 | -0.022 Log10 (IU/mL) | Standard Deviation 0.0543 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=7,6,13,10,9 | -0.060 Log10 (IU/mL) | Standard Deviation 0.1002 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=7,6,12,10,9 | -0.071 Log10 (IU/mL) | Standard Deviation 0.1232 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=7,6,13,10,9 | -0.044 Log10 (IU/mL) | Standard Deviation 0.0728 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=6,6,13,10,8 | -0.017 Log10 (IU/mL) | Standard Deviation 0.1918 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=7,6,13,10,9 | -0.059 Log10 (IU/mL) | Standard Deviation 0.0959 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=7,6,12,10,9 | -0.042 Log10 (IU/mL) | Standard Deviation 0.0926 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=7,6,13,11,9 | -0.068 Log10 (IU/mL) | Standard Deviation 0.1008 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=7,6,12,10,9 | -0.062 Log10 (IU/mL) | Standard Deviation 0.1232 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=7,6,13,10,9 | -0.067 Log10 (IU/mL) | Standard Deviation 0.1146 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=7,6,12,9,9 | -0.028 Log10 (IU/mL) | Standard Deviation 0.0556 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=7,6,12,10,9 | 0.017 Log10 (IU/mL) | Standard Deviation 0.3365 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=7,6,15,11,10 | -0.051 Log10 (IU/mL) | Standard Deviation 0.0802 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=7,6,13,10,9 | -0.002 Log10 (IU/mL) | Standard Deviation 0.1413 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=7,6,13,10,9 | -0.040 Log10 (IU/mL) | Standard Deviation 0.1506 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=7,6,13,10,9 | -0.020 Log10 (IU/mL) | Standard Deviation 0.0405 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=7,6,12,10,9 | -0.122 Log10 (IU/mL) | Standard Deviation 0.1563 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=7,6,13,10,9 | 0.015 Log10 (IU/mL) | Standard Deviation 0.0858 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=7,6,13,10,9 | -0.068 Log10 (IU/mL) | Standard Deviation 0.2413 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=7,6,12,10,9 | -0.057 Log10 (IU/mL) | Standard Deviation 0.138 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=7,6,13,10,9 | -0.101 Log10 (IU/mL) | Standard Deviation 0.1618 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=6,6,13,10,8 | -0.117 Log10 (IU/mL) | Standard Deviation 0.1544 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=7,6,13,11,9 | -0.081 Log10 (IU/mL) | Standard Deviation 0.1414 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=7,6,12,10,9 | -0.118 Log10 (IU/mL) | Standard Deviation 0.1636 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=7,6,13,10,9 | -0.009 Log10 (IU/mL) | Standard Deviation 0.0976 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=7,6,13,10,9 | 0.013 Log10 (IU/mL) | Standard Deviation 0.5325 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=7,6,13,10,9 | -0.011 Log10 (IU/mL) | Standard Deviation 0.1237 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=7,6,15,11,10 | 0.012 Log10 (IU/mL) | Standard Deviation 0.0586 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=7,6,12,9,9 | 0.022 Log10 (IU/mL) | Standard Deviation 0.0883 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=7,6,13,10,9 | -0.085 Log10 (IU/mL) | Standard Deviation 0.1189 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=7,6,13,10,9 | -0.039 Log10 (IU/mL) | Standard Deviation 0.2732 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=7,6,12,10,9 | -0.085 Log10 (IU/mL) | Standard Deviation 0.12 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=7,6,13,10,9 | -0.109 Log10 (IU/mL) | Standard Deviation 0.1562 |
Secondary
Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up)
Blood samples were collected from participants to assess HBsAg level. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Time frame: Baseline (Day 1 pre-dose), Day 270, Day 360 and Day 450
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 270, n=10,5,17,13,15 | -0.0177 Log10 (IU/mL) | Standard Deviation 0.08736 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 450, n=9,5,17,11,15 | -0.1282 Log10 (IU/mL) | Standard Deviation 0.09933 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 360, n=10,5,17,12,14 | -0.0723 Log10 (IU/mL) | Standard Deviation 0.11352 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 270, n=10,5,17,13,15 | 0.0308 Log10 (IU/mL) | Standard Deviation 0.07338 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 450, n=9,5,17,11,15 | -0.0551 Log10 (IU/mL) | Standard Deviation 0.11173 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 360, n=10,5,17,12,14 | -0.0397 Log10 (IU/mL) | Standard Deviation 0.06918 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 270, n=10,5,17,13,15 | 0.0627 Log10 (IU/mL) | Standard Deviation 0.21462 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 450, n=9,5,17,11,15 | -0.0615 Log10 (IU/mL) | Standard Deviation 0.08487 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 360, n=10,5,17,12,14 | -0.0265 Log10 (IU/mL) | Standard Deviation 0.08988 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 360, n=10,5,17,12,14 | -0.0239 Log10 (IU/mL) | Standard Deviation 0.07252 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 450, n=9,5,17,11,15 | -0.0350 Log10 (IU/mL) | Standard Deviation 0.08041 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 270, n=10,5,17,13,15 | 0.0400 Log10 (IU/mL) | Standard Deviation 0.05783 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 270, n=10,5,17,13,15 | -0.0047 Log10 (IU/mL) | Standard Deviation 0.35902 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 360, n=10,5,17,12,14 | -0.1175 Log10 (IU/mL) | Standard Deviation 0.21454 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Day 450, n=9,5,17,11,15 | -0.1557 Log10 (IU/mL) | Standard Deviation 0.1872 |
Secondary
Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Blood samples were collected from participants to assess HBsAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Time frame: Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -0.0046 Log10 (IU/mL) | Standard Deviation 0.09142 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | -0.0149 Log10 (IU/mL) | Standard Deviation 0.07545 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=9,6,20,14,14 | -0.0212 Log10 (IU/mL) | Standard Deviation 0.08048 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,15,15 | -0.0248 Log10 (IU/mL) | Standard Deviation 0.06304 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -0.0307 Log10 (IU/mL) | Standard Deviation 0.05677 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.0252 Log10 (IU/mL) | Standard Deviation 0.0633 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | -0.0178 Log10 (IU/mL) | Standard Deviation 0.07303 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.0502 Log10 (IU/mL) | Standard Deviation 0.10885 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.0124 Log10 (IU/mL) | Standard Deviation 0.06586 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.0132 Log10 (IU/mL) | Standard Deviation 0.09127 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | -0.0280 Log10 (IU/mL) | Standard Deviation 0.06764 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | -0.0118 Log10 (IU/mL) | Standard Deviation 0.0617 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | -0.0395 Log10 (IU/mL) | Standard Deviation 0.08067 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | -0.0175 Log10 (IU/mL) | Standard Deviation 0.07296 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,13 | -0.0462 Log10 (IU/mL) | Standard Deviation 0.12954 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | -0.0334 Log10 (IU/mL) | Standard Deviation 0.08425 |
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,19,14,15 | -0.0130 Log10 (IU/mL) | Standard Deviation 0.08312 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | -0.1010 Log10 (IU/mL) | Standard Deviation 0.06003 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | -0.0874 Log10 (IU/mL) | Standard Deviation 0.05607 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | -0.0959 Log10 (IU/mL) | Standard Deviation 0.06731 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | -0.1388 Log10 (IU/mL) | Standard Deviation 0.0862 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | -0.0057 Log10 (IU/mL) | Standard Deviation 0.05207 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -0.1250 Log10 (IU/mL) | Standard Deviation 0.08371 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | -0.0296 Log10 (IU/mL) | Standard Deviation 0.03871 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.1084 Log10 (IU/mL) | Standard Deviation 0.06213 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.1689 Log10 (IU/mL) | Standard Deviation 0.1305 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,13 | -0.1431 Log10 (IU/mL) | Standard Deviation 0.08963 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,15,15 | -0.0302 Log10 (IU/mL) | Standard Deviation 0.03943 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.0417 Log10 (IU/mL) | Standard Deviation 0.04609 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.0416 Log10 (IU/mL) | Standard Deviation 0.07503 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=9,6,20,14,14 | -0.1312 Log10 (IU/mL) | Standard Deviation 0.06855 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,19,14,15 | -0.1065 Log10 (IU/mL) | Standard Deviation 0.09399 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | -0.0895 Log10 (IU/mL) | Standard Deviation 0.06557 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -0.0295 Log10 (IU/mL) | Standard Deviation 0.03644 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.3249 Log10 (IU/mL) | Standard Deviation 0.24978 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,13 | -0.3411 Log10 (IU/mL) | Standard Deviation 0.22578 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,19,14,15 | -0.3438 Log10 (IU/mL) | Standard Deviation 0.29089 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=9,6,20,14,14 | -0.3374 Log10 (IU/mL) | Standard Deviation 0.31804 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -0.0975 Log10 (IU/mL) | Standard Deviation 0.08478 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | -0.0376 Log10 (IU/mL) | Standard Deviation 0.08685 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | -0.0872 Log10 (IU/mL) | Standard Deviation 0.12991 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.1420 Log10 (IU/mL) | Standard Deviation 0.10442 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.2197 Log10 (IU/mL) | Standard Deviation 0.25896 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,15,15 | -0.1543 Log10 (IU/mL) | Standard Deviation 0.16457 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | -0.2650 Log10 (IU/mL) | Standard Deviation 0.28541 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | -0.2389 Log10 (IU/mL) | Standard Deviation 0.12015 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | -0.2671 Log10 (IU/mL) | Standard Deviation 0.31301 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | -0.3131 Log10 (IU/mL) | Standard Deviation 0.28058 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.3018 Log10 (IU/mL) | Standard Deviation 0.20862 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -0.3171 Log10 (IU/mL) | Standard Deviation 0.27547 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | -0.3307 Log10 (IU/mL) | Standard Deviation 0.25414 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | -0.3612 Log10 (IU/mL) | Standard Deviation 0.55395 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,15,15 | -0.1200 Log10 (IU/mL) | Standard Deviation 0.09169 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | -0.3628 Log10 (IU/mL) | Standard Deviation 0.20369 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | -0.0690 Log10 (IU/mL) | Standard Deviation 0.06427 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.1793 Log10 (IU/mL) | Standard Deviation 0.08003 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | -0.2105 Log10 (IU/mL) | Standard Deviation 0.08617 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | -0.2370 Log10 (IU/mL) | Standard Deviation 0.12134 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | -0.2603 Log10 (IU/mL) | Standard Deviation 0.10027 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -0.2925 Log10 (IU/mL) | Standard Deviation 0.09666 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.3722 Log10 (IU/mL) | Standard Deviation 0.28298 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,19,14,15 | -0.4532 Log10 (IU/mL) | Standard Deviation 0.46786 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=9,6,20,14,14 | -0.4429 Log10 (IU/mL) | Standard Deviation 0.50368 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,13 | -0.4291 Log10 (IU/mL) | Standard Deviation 0.56931 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.4327 Log10 (IU/mL) | Standard Deviation 0.55294 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | -0.0573 Log10 (IU/mL) | Standard Deviation 0.03889 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.2246 Log10 (IU/mL) | Standard Deviation 0.38875 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -0.1038 Log10 (IU/mL) | Standard Deviation 0.22824 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 64, n=10,6,20,14,15 | -0.6261 Log10 (IU/mL) | Standard Deviation 0.40132 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 57, n=10,6,20,14,15 | -0.5962 Log10 (IU/mL) | Standard Deviation 0.34848 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 50, n=10,6,19,14,15 | -0.5600 Log10 (IU/mL) | Standard Deviation 0.3175 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 99, n=10,6,20,14,15 | -0.5981 Log10 (IU/mL) | Standard Deviation 0.48977 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 43, n=10,6,20,14,15 | -0.4923 Log10 (IU/mL) | Standard Deviation 0.23961 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 36, n=10,6,20,14,15 | -0.4798 Log10 (IU/mL) | Standard Deviation 0.21487 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 8, n=10,6,20,15,15 | -0.0944 Log10 (IU/mL) | Standard Deviation 0.08417 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 113, n=10,6,20,14,15 | -0.4228 Log10 (IU/mL) | Standard Deviation 0.36072 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 29, n=10,6,20,13,15 | -0.4512 Log10 (IU/mL) | Standard Deviation 0.22095 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 22, n=10,6,20,15,15 | -0.3345 Log10 (IU/mL) | Standard Deviation 0.17978 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 15, n=10,6,20,14,15 | -0.2103 Log10 (IU/mL) | Standard Deviation 0.13356 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 169, n=10,6,19,14,15 | -0.1822 Log10 (IU/mL) | Standard Deviation 0.21674 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 85, n=9,6,20,14,14 | -0.7531 Log10 (IU/mL) | Standard Deviation 0.64776 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 78, n=10,6,19,14,15 | -0.7088 Log10 (IU/mL) | Standard Deviation 0.57034 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 71, n=10,6,20,14,15 | -0.6357 Log10 (IU/mL) | Standard Deviation 0.42715 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 141, n=10,6,20,14,15 | -0.2729 Log10 (IU/mL) | Standard Deviation 0.23994 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Day 92, n=10,6,19,14,13 | -0.6794 Log10 (IU/mL) | Standard Deviation 0.62942 |
Secondary
Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis)
Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Time frame: Baseline (Day 1 pre-dose) and Up to Day 169
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | -0.128 Log10 (IU/mL) | Standard Deviation 0.4044 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | -0.426 Log10 (IU/mL) | Standard Deviation 0.6603 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | -0.643 Log10 (IU/mL) | Standard Deviation 0.6594 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | -0.341 Log10 (IU/mL) | Standard Deviation 0.7591 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | -0.256 Log10 (IU/mL) | Standard Deviation 0.5295 |
Secondary
Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up)
Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).
Time frame: Baseline (Day 1 pre-dose) and Up to Day 450
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 2: GSK3389404 30 mg Weekly | Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | -0.128 Log10 (IU/mL) | Standard Deviation 0.4044 |
| Part 1: GSK3389404 120 mg | Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | -0.426 Log10 (IU/mL) | Standard Deviation 0.6603 |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | -0.643 Log10 (IU/mL) | Standard Deviation 0.6594 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | -0.426 Log10 (IU/mL) | Standard Deviation 0.7893 |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | -0.256 Log10 (IU/mL) | Standard Deviation 0.5295 |
Secondary
Part 2: Cmax of GSK3389404 Metabolite (ISIS 505358)
Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: GSK3389404 120 mg | Part 2: Cmax of GSK3389404 Metabolite (ISIS 505358) | NA Nanogram per milliliter | — |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Cmax of GSK3389404 Metabolite (ISIS 505358) | NA Nanogram per milliliter | — |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Cmax of GSK3389404 Metabolite (ISIS 505358) | 2.91 Nanogram per milliliter | Geometric Coefficient of Variation 77.5 |
Secondary
Part 2: t1/2 of GSK3389404 Metabolite (ISIS 505358)
Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 2: GSK3389404 120 mg Weekly | Part 2: t1/2 of GSK3389404 Metabolite (ISIS 505358) | 10.66 Hours |
Secondary
Part 2: Tmax of GSK3389404 Metabolite (ISIS 505358)
Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Time frame: Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169
Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: GSK3389404 120 mg | Part 2: Tmax of GSK3389404 Metabolite (ISIS 505358) | 7.93 Hours |
| Part 2: GSK3389404 120 mg Bi-weekly | Part 2: Tmax of GSK3389404 Metabolite (ISIS 505358) | 7.93 Hours |
| Part 2: GSK3389404 120 mg Weekly | Part 2: Tmax of GSK3389404 Metabolite (ISIS 505358) | 8.00 Hours |