Neoplasms
Conditions
Keywords
pembrolizumab, GSK1795091, Dose-escalation, 204686, Immunotherapies, GSK3359609, Phase I, anticancer agent, OX40, 201212, 204691, ICOS, TLR4, GSK3174998, Advanced Solid Tumors
Brief summary
GSK1795091 is being developed for administration in combination with other immune system modulators for the treatment of cancers. The study will be conducted in two parts. In Part 1, dose escalation will be performed to identify combination dose levels comprising GSK1795091 with either 24 milligrams (mg) GSK3174998 (Part 1a), 80 mg GSK3359609 (Part 1b), or 200 mg pembrolizumab (Part 1c). One dose level of GSK3174998, GSK3359609, or pembrolizumab with up to 5 dose levels of GSK1795091 are planned for evaluation. In Part 2 (dose-expansion), subjects will receive a single dose level of GSK1795091 as identified based on data from Part 1, in combination with either GSK3174998, GSK3359609, or pembrolizumab.
Interventions
GSK1795091 will be available as solution for injection
GSK3174998 will be available as lyophilized powder to be reconstituted for infusion.
GSK3359609 will be available as solution for infusion.
Pembrolizumab will be available as solution for infusion or lyophilized powder for reconstitution.
Sponsors
Study design
Intervention model description
In Part 1, one dose level of GSK3174998, GSK3359609, or pembrolizumab with up to 5 dose levels of GSK1795091 are planned for evaluation. Sequential cohorts will be enrolled and dose escalation (or de-escalation) will proceed according to Neuenschwander-Continual Reassessment Method (N-CRM design). In Part 2, subjects will be administered GSK1795091 in combination with either 24 mg GSK3174998, 80 mg GSK3359609, or 200 mg pembrolizumab at a dose identified in Part 1.
Eligibility
Inclusion criteria
* Subject must be \>=18 years of at the time of signing the informed consent. * Histological documentation of advanced solid tumor. * Archival tumor tissue obtained at any time from the initial diagnosis to study entry. Although a fresh biopsy obtained during screening is preferred, archival tumor specimen is acceptable if it is not feasible to obtain a fresh biopsy. Subjects enrolled in a PK/Pharmacodynamic Cohort must provide a fresh biopsy of a tumor lesion not previously irradiated during the screening period and must agree to provide at least one additional on-treatment biopsy. * Disease that has progressed after standard therapies or for which standard therapy is otherwise unsuitable (example, intolerance). * Measurable disease, that is, presenting with at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * Life expectancy of at least 12 weeks. * Adequate organ function. * In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. * Male or female subjects will be included. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a) Not a woman of childbearing potential (WOCBP) OR b). A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions specified. Additional Inclusion criteria for Subjects in Part 2a (GSK3174998 expansion) and Part 2b (GSK3359609 expansion): * Histological or cytological documentation of squamous cell carcinoma of the head and neck (SCCHN) (oral cavity, oropharynx, hypopharynx, or larynx) that is recurrent, locally advanced, or metastatic and is not amenable to curative treatment options, surgery or definitive chemoradiation therapy. * Received, ineligible for, or otherwise unsuitable for platinum-based therapy and anti-Programmed death receptor-1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy * Received no more than 3 prior lines of systemic therapy for metastatic disease. Additional Inclusion Criteria for Subjects in Part 2c (pembrolizumab expansion): * Histological or cytological documentation of SCCHN (oral cavity, oropharynx, hypopharynx, or larynx) that is recurrent, locally advanced, or metastatic and is not amenable to curative treatment options, surgery or definitive chemoradiation therapy. * Received no more than 2 prior lines of systemic therapy for metastatic disease.
Exclusion criteria
* Malignancy other than disease under study with the exception of those from which the subject has been disease-free for more than 2 years and not expected to affect the safety of the subject or the endpoints of the trial. * Symptomatic central nervous system (CNS) metastases or asymptomatic CNS metastases that have required steroids within 2 weeks prior to first dose of study treatment. * Active autoimmune disease that has required systemic disease modifying or immunosuppressive treatment within the last 2 years. Replacement therapy (example, thyroxine or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted. * Concurrent medical condition requiring the use of systemic immunosuppressive treatment within 28 days before the first dose of study treatment. * Known human immunodeficiency virus infection. * Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. * Presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study treatment. * Positive Hepatitis C test result at screening or within 3 months prior to first dose of study treatment. * QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 milliseconds (msec) or QTcF \>480 msec for subjects with bundle branch block * Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction. * Recent history of allergen desensitization therapy within 4 weeks of starting study treatment. * History of severe hypersensitivity to monoclonal antibodies (mAbs). * History or evidence of cardiovascular (CV) risk including any of the following: a) Recent (within the past 6 months) history of serious uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second degree (Type II) or third degree atrioventricular block. b) Cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting within the past 6 months before enrollment. c) Congestive heart failure (Class II, III, or IV) as defined by the New York Heart Association (NYHA) functional classification system. d) Recent (within the past 6 months) history of symptomatic pericarditis. * History of idiopathic pulmonary fibrosis, pneumonitis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis. * Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions. * Any serious and/or unstable pre-existing medical, psychiatric disorder, or other condition that could interfere with the subject's safety, obtaining informed consent, or compliance to the study procedures. * Is or has an immediate family member (example, spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective Institutional Review Board (IRB) approval (by chair or designee) is given allowing exception to this criterion for a specific subject. * Prior treatment with the following agents: a) OX40, inducible T-cell co-stimulator (ICOS) agonist at any time. b) Prior systemic or intratumoral therapy with TLR agonist. c) Anticancer therapy or investigational therapy within 30 days or 5 half-lives of the drug, whichever is shorter. d) Prior radiation therapy: permissible if at least 1 non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 14 days before start of study treatment for radiation of any intended use to the extremities for bone metastases and 28 days for radiation to the chest, brain, or visceral organs is required. * Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation. * Toxicity from previous treatment including: a) Toxicity Grade \>=3 related to prior immunotherapy and that lead to study treatment discontinuation. b) Toxicity related to prior treatment has not resolved to Grade \<=1 (except alopecia, or endocrinopathy managed with replacement therapy). * Received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor, and recombinant erythropoietin) within 2 weeks before the first dose of study treatment. * Major surgery \<=4 weeks before the first dose of study treatment. Subjects must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment. * Known drug or alcohol abuse. * Receipt of any live vaccine within 4 weeks. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: Number of Participants With Vital Signs Any Increases From Baseline According to Markedly Abnormal Criteria | Up to 2 years | Vital signs including SBP, DBP, pulse rate and body temperature were planned to be measured in a semi-supine position after 5 minutes rest for the participants. |
| Part 2: Number of Participants With Any QTcF Interval Increases From Baseline According to Markedly Abnormal Criteria | Up to 2 years | 12-lead ECG was planned to be performed to measure QTcF interval. |
| Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria | Up to 2 years | 12-lead electrocardiogram (ECG) was obtained at indicated time point using an automated ECG machine that measured QTcF interval. QTc parameters were graded according to National Cancer Institute - CTCAE version 4.0. Grade 1 (\>450 milliseconds \[msec\]), Grade 2 (\>480 msec), Grade 3 (\>500 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst case on therapy is presented. |
| Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Up to 2 years | Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured in a semi-supine position after 5 minutes rest for the participants. SBP: Category1 (\>140 and \<161 millimeter of mercury\[mmHg\]), Category 2 (\>=161 and \<181 mmHg), Category3 (\>=181 mmHg); DBP: Category1 (\>90 and \<101 mmHg), Category 2 (\>=101 and \<111 mmHg), Category 3 (\>=111 mmHg); PR: Category 1 (\>101 and \<116 beats per minutes\[bpm\]), Category 2 (\>=116 and \<131 bpm), Category 3 (\>=131 bpm); BT: Category 1 (\>38.0 and \<38.6 degrees Celsius), Category 2 (\>=38.6 and \<39.1 degrees Celsius), Category 3 (\>=39.1 degrees Celsius). Data for any increase in category at worst case on therapy is presented. |
| Part 2: Number of Participants With Vital Signs Any Decreases From Baseline According to Markedly Abnormal Criteria | Up to 2 years | Vital signs including SBP, DBP and pulse rate were planned to be measured in a semi-supine position after 5 minutes rest for the participants. |
| Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Up to 2 years | Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest for the participants. For SBP: a decrease in Category was defined as \<80 mmHg decrease from Baseline; DBP: decrease defined as Category (\<50 mmHg decrease from Baseline); pulse rate: decrease defined as Category (\<45 bpm decrease from Baseline). Data for decrease in category at worst case on therapy is presented. |
| Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | Up to 27 months | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. All Treated Population consisted of all participants who received at least 1 dose of GSK1795091, GSK3174998, GSK3359609, or pembrolizumab. |
| Part 2: Number of Participants With TEAEs and STEAEs | Up to 27 months | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. |
| Part 1: Number of Participants With Dose-limiting Toxicity (DLT) | 42 days | An adverse event was considered to be a DLT if it was considered by investigator to be clinically relevant and attributed (definitely, probably or possibly) to study treatment and met one of the criteria: hematologic toxicity-Grade4 neutropenia of \>7 days duration or febrile neutropenia, Grade 4 anemia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, non-hematologic toxicity-Grade 4 toxicity, Grade 3 toxicity that does not resolve to \<=Grade 1 or Baseline within 14 days despite optimal supportive care, alanine aminotransferase (ALT) \>=5 times upper limit of normal (ULN), ALT \>=3 times ULN persists for \>=4 weeks, ALT \>=3 times ULN and bilirubin \>=2 times ULN (\>35 percent \[%\] direct bilirubin), ALT \>=3 times ULN and international normalized ratio (INR) \>1.5, ALT \>=3 times ULN associated with symptoms (new or worsening) believed to be related to liver injury or hypersensitivity. |
| Part 1: Number of Participants With TEAEs Leading to Discontinuation | Up to 2 years | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. |
| Part 2: Number of Participants With TEAEs Leading to Discontinuation | Up to 2 years | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. |
| Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays | Up to 2 years | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. |
| Part 2: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays | Up to 2 years | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. |
| Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baseline (Day 1: Pre-dose) and up to 2 years | Blood samples were collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho), monocytes (Mono), eosinophils (Eosino), basophils (Baso), hemoglobin (Hb), hematocrit (Hct), erythrocytes (Erythro), erythrocyte mean corpuscular volume (EMCV), erythrocyte mean corpuscular hemoglobin (EMCH) and platelet count (PC). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data was categorized as decrease to low (D to L) (value below lower limit of normal range \[LNR\]) and increase to high (I to H) (value above upper LNR). Participants were counted twice if participant had both decreased to low and increased to high within an assessment. Data for worst-case on therapy for categories decrease to low and increase to high is presented. |
| Part 2: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baseline (Day 1: Pre-dose) and up to 2 years | Blood samples were planned to be collected for the analysis of following hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, erythrocytes, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin and platelet count. |
| Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Baseline (Day 1: Pre-dose) and up to 2 years | Blood samples were collected for the analysis of following chemistry parameters: urea, creatinine (Cr), glucose (Glu), potassium (Pot), sodium (Sod), calcium (Cal), aspartate aminotransferase (AST), ALT, alkaline phosphatase (ALP), bilirubin (Bil), direct bilirubin (D.Bil), protein, albumin (Alb), C-reactive protein (CRP) and Creatinine Clearance (CrCl). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data was categorized as decrease to low (value below the lower LNR), and increase to high (value above the upper LNR). Participants were counted twice if the participant had both decreased to low and increased to high within an assessment. Data for worst case on therapy for categories decrease to low and increase to high is presented. |
| Part 2: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Baseline (Day 1: Pre-dose) and up to 2 years | Blood samples were planned to be collected for the analysis of following chemistry parameters: urea, creatinine, glucose, potassium, sodium, calcium, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, bilirubin, direct bilirubin, protein, albumin, C-reactive protein and Creatinine Clearance. |
| Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Up to 2 years | Urine samples were collected for the analysis of following urinalysis parameters: glucose (Glu), protein (Pro), occult blood (OB), ketones, potential of hydrogen (pH) and specific gravity (SpGr) by dipstick method. The dipstick test gives results in a semi-quantitative manner. 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. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Data was categorized as decrease to low (value below the lower LNR) and increase to high (value above the upper LNR). Participants were counted twice if the participant had both decreased to low and increased to high within an assessment. Data for worst-case on therapy for categories decrease to low and increase to high is presented. |
| Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Up to 2 years | Urine samples were planned to be collected for the analysis of following urine parameters: glucose, protein, occult blood, ketones, potential of hydrogen and specific gravity by dipstick method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091 | Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-dose | Blood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091. |
| Part 1b: AUC(0-tau) GSK1795091 | Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose | Blood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091. |
| Part 1c: AUC(0-tau) GSK1795091 | Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose | Blood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091. |
| Part 1a: Predose Concentration (Cpre) of GSK1795091 | Days 1, 8, 15, 22, 57, 64, 78, 162, 246, 414 and 498: Pre-dose | Blood samples were collected at indicated time points for the determination of Cpre of GSK1795091. |
| Part 1b: Cpre of GSK1795091 | Days 1, 8, 15, 22, 57, 64 and 78: Pre-dose | Blood samples were collected at indicated time points for the determination of Cpre of GSK1795091. |
| Part 1c: Cpre of GSK1795091 | Days 1, 8, 15, 22, 57, 64 and 78: Pre-dose | Blood samples were collected at indicated time points for the determination of Cpre of GSK1795091. |
| Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK3174998 | Up to 27 months | Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3174998. The presence of anti-GSK3174998 antibodies were assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay). |
| Part 1b: Number of Participants With the Present ADA Against GSK3359609 | Up to 27 months | Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3359609. The presence of anti-GSK3359609 antibodies were assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay). |
| Part 1c: Number of Participants With the Present ADA Against Pembrolizumab | Up to 27 months | Serum samples were collected at indicated time points for the presence of antibodies that bind to pembrolizumab. The presence of anti-pembrolizumab antibodies were planned to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay). |
| Part 2b: Number of Participants With the Present ADA Against GSK3359609 | Up to 2 years | Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to GSK3359609. The presence of anti-GSK3359609 antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay). |
| Part 2c: Number of Participants With the Present ADA Against Pembrolizumab | Up to 2 years | Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to pembrolizumab. The presence of anti-pembrolizumab antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay). |
| Part 2a: Number of Participants With the Present ADA Against GSK3174998 | Up to 2 years | Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to GSK3174998. The presence of anti-GSK3174998 antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay). |
| Part 1: Objective Response Rate | Up to 47 months and 13 days | Objective response rate is defined as the percentage of participants achieving a confirmed best overall response of complete response (CR) or partial response (PR) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. |
| Part 2: Objective Response Rate | Up to 47 months and 13 days | Objective response rate is defined as the percentage of participants achieving a confirmed best overall response of CR or PR evaluated using RECIST v 1.1, where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. |
| Part 1: Disease Control Rate | Up to 47 months and 13 days | Disease control rate is defined as the percentage of participants with a confirmed best overall response of CR or PR or at least 12 weeks of stable disease per RECIST v 1.1. |
| Part 2: Disease Control Rate | Up to 47 months and 13 days | Disease control rate is defined as the percentage of participants with a confirmed best overall response of CR or PR or at least 12 weeks of stable disease per RECIST v 1.1. |
| Part 1: Time to Response | Up to 47 months and 13 days | Time to response is defined as the time from the date of first dose to the date of the first documented evidence of response (PR or CR). |
| Part 2: Time to Response | Up to 47 months and 13 days | Time to response is defined as the time from the date of first dose to the date of the first documented evidence of response (PR or CR). |
| Part 1: Duration of Response | Up to 47 months and 13 days | Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve an overall response (that is., a confirmed best overall response of CR or PR) by RECIST v 1.1. |
| Part 2: Duration of Response | Up to 47 months and 13 days | Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve an overall response (that is., a confirmed best overall response of CR or PR) by RECIST v 1.1. |
| Part 1: Progression-free Survival | Up to 47 months and 13 days | Progression-free survival is defined as the interval of time (in months) between the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest. PFS was determined according to RECIST version 1.1. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. |
| Part 2: Progression-free Survival | Up to 47 months and 13 days | Progression-free survival is defined as the interval of time (in months) between the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest by RECIST v 1.1. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. |
| Part 1: Overall Survival | Up to 47 months and 13 days | Overall survival is defined as time from the date of first dose of study treatment (whichever investigational drug administered first) to the date of death due to any cause. |
| Part 2: Overall Survival | Up to 47 months and 13 days | Overall survival is defined as time from the date of first dose of study treatment (whichever investigational drug administered first) to the date of death due to any cause. |
| Part 1a: Plasma Concentration of GSK1795091 | Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-dose | Blood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091. Pharmacokinetic (PK) Population consisted of all participants from the All Treated population for whom a PK sample was obtained, analyzed, measurable, and valid. |
| Part 1b: Plasma Concentration of GSK1795091 | Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose | Blood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091. |
| Part 1c: Plasma Concentration of GSK1795091 | Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose | Blood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091. |
| Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-dose | Blood samples were collected at indicated time points for the determination of Cmax of GSK1795091. |
| Part 1b: Cmax of GSK1795091 | Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose | Blood samples were collected at indicated time points for the determination of Cmax of GSK1795091. |
| Part 1c: Cmax of GSK1795091 | Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose | Blood samples were collected at indicated time points for the determination of Cmax of GSK1795091. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | Up to 47 months and 13 days | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. |
| Part 2: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Up to 2 years | Blood samples were planned to be collected for the analysis of following chemistry parameters: albumin, ALP, ALT, AST, bilirubin, calcium, creatinine, glucose, potassium and sodium. |
| Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Up to 2 years | Blood samples were collected for the analysis of following chemistry parameters: albumin (Hypo), ALP, ALT, AST, bilirubin, calcium (Hyper and Hypo), creatinine, glucose (Hyper and Hypo), potassium (Hyper and Hypo) and sodium (Hyper and Hypo). The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for any worst-case on therapy any grade increase has been presented. |
| Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Up to 2 years | Blood samples were planned to be collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho), hemoglobin (Hb) and platelet count (PC). |
| Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Up to 2 years | Blood samples were collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho) (Low), hemoglobin (Hb) (Low) and platelet count (PC). The laboratory parameters were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for any worst-case on therapy any grade increase has been presented. |
| Part 2: Number of Participants With TEAEs and STEAEs Until End of the Study | Up to 47 months and 13 days | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. |
Countries
Canada, Netherlands, Spain, United States
Participant flow
Recruitment details
This was a non-randomized, open-label study of GSK1795091 administered in combination with immunotherapies in participants with advanced solid tumors.
Pre-assignment details
Total 54 participants were enrolled in the study. GSK1795091 150 nanograms (ng), 200 and 250 ng arms of Parts 1b and 1c were not initiated as GSK1795091 was no longer supplied due to manufacturing issue. Part 2 was not initiated.
Participants by arm
| Arm | Count |
|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 Participants were administered GSK1795091 50 ng intravenously (IV) on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3174998 24 milligram (mg) administered at 3-week intervals (Q3W) via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. | 9 |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. | 6 |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 Participants were administered GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. | 9 |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 Participants were administered GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. | 4 |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 Participants were administered GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3174998 24 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was administered in combination with GSK3174998 24 mg at Q3W interval. | 2 |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval. | 6 |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with GSK3359609 80 mg at Q3W interval. | 5 |
| Part 1b: 150ng GSK1795091 + 80mg GSK3359609 Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval. | 0 |
| Part 1b: 200ng GSK1795091 + 80mg GSK3359609 Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval. | 0 |
| Part 1b: 250ng GSK1795091 + 80mg GSK3359609 Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with GSK3359609 80 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with GSK3359609 80 mg at Q3W interval. | 0 |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab Participants were administered GSK1795091 50 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 50 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 50 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval. | 7 |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab Participants were administered GSK1795091 100 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 100 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 100 ng IV was administered in combination with pembrolizumab 200 mg at Q3W interval. | 6 |
| Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab Participants were planned to administer GSK1795091 150 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 150 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 150 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval. | 0 |
| Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab Participants were planned to administer GSK1795091 200 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 200 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 200 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval. | 0 |
| Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab Participants were planned to administer GSK1795091 250 ng IV on Days 1 and 8 followed by once weekly administration of GSK1795091 250 ng IV in combination with pembrolizumab 200 mg administered at Q3W via the IV route until Week 12. From Week 12 onwards, GSK1795091 250 ng IV was planned to administer in combination with pembrolizumab 200 mg at Q3W interval. | 0 |
| Part 2a: GSK1795091 + 24 mg GSK3174998 Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3174998 24 mg. | 0 |
| Part 2b: GSK1795091 + 80 mg GSK3359609 Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with GSK3359609 80 mg. | 0 |
| Part 2c: GSK1795091 + 200 mg Pembrolizumab Participants were planned to receive GSK1795091 at a dose identified in Part 1 along with pembrolizumab 200 mg. | 0 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 (Up to 47 Months and 13 Days) | Death | 6 | 5 | 4 | 3 | 1 | 4 | 2 | 0 | 0 | 0 | 4 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1 (Up to 47 Months and 13 Days) | Disease progression | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1 (Up to 47 Months and 13 Days) | Investigator discretion | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1 (Up to 47 Months and 13 Days) | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1 (Up to 47 Months and 13 Days) | Reason for discontinuation was not recorded in the case report form | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1 (Up to 47 Months and 13 Days) | Withdrawal by Subject | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: 150ng GSK1795091 + 80mg GSK3359609 | Part 1b: 200ng GSK1795091 + 80mg GSK3359609 | Part 1b: 250ng GSK1795091 + 80mg GSK3359609 | Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1c: 150ng GSK1795091 + 200mg Pembrolizumab | Part 1c: 200ng GSK1795091 + 200mg Pembrolizumab | Part 1c: 250ng GSK1795091 + 200mg Pembrolizumab | Part 2a: GSK1795091 + 24 mg GSK3174998 | Part 2b: GSK1795091 + 80 mg GSK3359609 | Part 2c: GSK1795091 + 200 mg Pembrolizumab | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 19 - 64 years | 8 Participants | 7 Participants | 3 Participants | 0 Participants | 5 Participants | 4 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 37 Participants |
| Age, Customized >=65 years | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 17 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 6 Participants | 7 Participants | 4 Participants | 2 Participants | 5 Participants | 5 Participants | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 46 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 2 Participants | 0 Participants | 4 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 28 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 9 | 5 / 6 | 4 / 9 | 4 / 4 | 1 / 2 | 5 / 6 | 3 / 5 | 4 / 7 | 3 / 6 |
| other Total, other adverse events | 9 / 9 | 6 / 6 | 9 / 9 | 4 / 4 | 1 / 2 | 6 / 6 | 5 / 5 | 5 / 7 | 5 / 6 |
| serious Total, serious adverse events | 1 / 9 | 2 / 6 | 5 / 9 | 1 / 4 | 0 / 2 | 2 / 6 | 2 / 5 | 3 / 7 | 2 / 6 |
Outcome results
Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria
Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest for the participants. For SBP: a decrease in Category was defined as \<80 mmHg decrease from Baseline; DBP: decrease defined as Category (\<50 mmHg decrease from Baseline); pulse rate: decrease defined as Category (\<45 bpm decrease from Baseline). Data for decrease in category at worst case on therapy is presented.
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, SBP | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, Pulse rate | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, DBP | 2 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, Pulse rate | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, DBP | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, SBP | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, DBP | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, SBP | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, Pulse rate | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, Pulse rate | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, SBP | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, DBP | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, DBP | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, SBP | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, Pulse rate | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, DBP | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, SBP | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, Pulse rate | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, Pulse rate | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, SBP | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, DBP | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, DBP | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, Pulse rate | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, SBP | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, DBP | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, Pulse rate | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Any Decrease From Baseline in Vital Sign According to Markedly Abnormal Criteria | Any decrease, SBP | 0 Participants |
Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria
12-lead electrocardiogram (ECG) was obtained at indicated time point using an automated ECG machine that measured QTcF interval. QTc parameters were graded according to National Cancer Institute - CTCAE version 4.0. Grade 1 (\>450 milliseconds \[msec\]), Grade 2 (\>480 msec), Grade 3 (\>500 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst case on therapy is presented.
Time frame: Up to 2 years
Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria | 2 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria | 3 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Any Increase From Baseline in Corrected QT Interval Using Fredericia's Formula (QTcF) According to Markedly Abnormal Criteria | 1 Participants |
Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Blood samples were collected for the analysis of following chemistry parameters: urea, creatinine (Cr), glucose (Glu), potassium (Pot), sodium (Sod), calcium (Cal), aspartate aminotransferase (AST), ALT, alkaline phosphatase (ALP), bilirubin (Bil), direct bilirubin (D.Bil), protein, albumin (Alb), C-reactive protein (CRP) and Creatinine Clearance (CrCl). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data was categorized as decrease to low (value below the lower LNR), and increase to high (value above the upper LNR). Participants were counted twice if the participant had both decreased to low and increased to high within an assessment. Data for worst case on therapy for categories decrease to low and increase to high is presented.
Time frame: Baseline (Day 1: Pre-dose) and up to 2 years
Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CRP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, D to L, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | D.Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Glu, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Bil, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALP, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cal, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | AST, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Pot, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | ALT, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | CrCl, I to H, n=1,2,3,1,1,4,0,0,0,0,1,2,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Sod, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Cr, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Alb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Urea, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range | Protein, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Blood samples were collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho), monocytes (Mono), eosinophils (Eosino), basophils (Baso), hemoglobin (Hb), hematocrit (Hct), erythrocytes (Erythro), erythrocyte mean corpuscular volume (EMCV), erythrocyte mean corpuscular hemoglobin (EMCH) and platelet count (PC). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data was categorized as decrease to low (D to L) (value below lower limit of normal range \[LNR\]) and increase to high (I to H) (value above upper LNR). Participants were counted twice if participant had both decreased to low and increased to high within an assessment. Data for worst-case on therapy for categories decrease to low and increase to high is presented.
Time frame: Baseline (Day 1: Pre-dose) and up to 2 years
Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hct, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Baso, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Mono, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCH, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Neutro, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Hb, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | PC, I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Lympho, I to H, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Erythro, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | Eosino, D to L, n=8,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range | EMCV, D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
Part 1: Number of Participants With Dose-limiting Toxicity (DLT)
An adverse event was considered to be a DLT if it was considered by investigator to be clinically relevant and attributed (definitely, probably or possibly) to study treatment and met one of the criteria: hematologic toxicity-Grade4 neutropenia of \>7 days duration or febrile neutropenia, Grade 4 anemia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, non-hematologic toxicity-Grade 4 toxicity, Grade 3 toxicity that does not resolve to \<=Grade 1 or Baseline within 14 days despite optimal supportive care, alanine aminotransferase (ALT) \>=5 times upper limit of normal (ULN), ALT \>=3 times ULN persists for \>=4 weeks, ALT \>=3 times ULN and bilirubin \>=2 times ULN (\>35 percent \[%\] direct bilirubin), ALT \>=3 times ULN and international normalized ratio (INR) \>1.5, ALT \>=3 times ULN associated with symptoms (new or worsening) believed to be related to liver injury or hypersensitivity.
Time frame: 42 days
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Dose-limiting Toxicity (DLT) | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Dose-limiting Toxicity (DLT) | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Dose-limiting Toxicity (DLT) | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Dose-limiting Toxicity (DLT) | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Dose-limiting Toxicity (DLT) | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Dose-limiting Toxicity (DLT) | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Dose-limiting Toxicity (DLT) | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Dose-limiting Toxicity (DLT) | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Dose-limiting Toxicity (DLT) | 1 Participants |
Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured in a semi-supine position after 5 minutes rest for the participants. SBP: Category1 (\>140 and \<161 millimeter of mercury\[mmHg\]), Category 2 (\>=161 and \<181 mmHg), Category3 (\>=181 mmHg); DBP: Category1 (\>90 and \<101 mmHg), Category 2 (\>=101 and \<111 mmHg), Category 3 (\>=111 mmHg); PR: Category 1 (\>101 and \<116 beats per minutes\[bpm\]), Category 2 (\>=116 and \<131 bpm), Category 3 (\>=131 bpm); BT: Category 1 (\>38.0 and \<38.6 degrees Celsius), Category 2 (\>=38.6 and \<39.1 degrees Celsius), Category 3 (\>=39.1 degrees Celsius). Data for any increase in category at worst case on therapy is presented.
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, SBP | 7 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Body temperature | 1 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Pulse rate | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, DBP | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, SBP | 3 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Body temperature | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, DBP | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Pulse rate | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, DBP | 3 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, SBP | 6 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Body temperature | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Pulse rate | 4 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, DBP | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, SBP | 3 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Pulse rate | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Body temperature | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Body temperature | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, SBP | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, DBP | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Pulse rate | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, SBP | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, DBP | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Body temperature | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Pulse rate | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, DBP | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Pulse rate | 2 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, SBP | 2 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Body temperature | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, DBP | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, SBP | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Body temperature | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Pulse rate | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, DBP | 3 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Pulse rate | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, Body temperature | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Increase From Baseline in Vital Signs According to Markedly Abnormal Criteria | Any increase, SBP | 3 Participants |
Part 1: Number of Participants With TEAEs Leading to Discontinuation
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs Leading to Discontinuation | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs Leading to Discontinuation | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs Leading to Discontinuation | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs Leading to Discontinuation | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs Leading to Discontinuation | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With TEAEs Leading to Discontinuation | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With TEAEs Leading to Discontinuation | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With TEAEs Leading to Discontinuation | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With TEAEs Leading to Discontinuation | 1 Participants |
Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays | 4 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays | 2 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays | 4 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays | 2 Participants |
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs)
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication. All Treated Population consisted of all participants who received at least 1 dose of GSK1795091, GSK3174998, GSK3359609, or pembrolizumab.
Time frame: Up to 27 months
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | TEAEs | 9 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | STEAEs | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | TEAEs | 6 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | STEAEs | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | TEAEs | 9 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | STEAEs | 5 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | TEAEs | 4 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | STEAEs | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | TEAEs | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | STEAEs | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | STEAEs | 2 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | TEAEs | 6 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | STEAEs | 2 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | TEAEs | 5 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | TEAEs | 5 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | STEAEs | 3 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | TEAEs | 6 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (STEAEs) | STEAEs | 2 Participants |
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Urine samples were collected for the analysis of following urinalysis parameters: glucose (Glu), protein (Pro), occult blood (OB), ketones, potential of hydrogen (pH) and specific gravity (SpGr) by dipstick method. The dipstick test gives results in a semi-quantitative manner. 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. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Data was categorized as decrease to low (value below the lower LNR) and increase to high (value above the upper LNR). Participants were counted twice if the participant had both decreased to low and increased to high within an assessment. Data for worst-case on therapy for categories decrease to low and increase to high is presented.
Time frame: Up to 2 years
Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 3 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: I to H, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Pro: D to L, n=9,2,7,1,2,4,0,0,0,0,4,0,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: D to L, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | pH: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Glu: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: I to H, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | SpGr: I to H, n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: D to L, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | OB: D to L, n=4,5,8,1,1,4,2,0,0,0,1,4,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria | Ketones: I to H, n=9,5,8,1,2,4,2,0,0,0,0,5,0,0,0 | 0 Participants |
Part 2: Number of Participants With Any QTcF Interval Increases From Baseline According to Markedly Abnormal Criteria
12-lead ECG was planned to be performed to measure QTcF interval.
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Number of Participants With Change From Baseline in Chemistry Parameters With Respect to the Normal Range
Blood samples were planned to be collected for the analysis of following chemistry parameters: urea, creatinine, glucose, potassium, sodium, calcium, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, bilirubin, direct bilirubin, protein, albumin, C-reactive protein and Creatinine Clearance.
Time frame: Baseline (Day 1: Pre-dose) and up to 2 years
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Blood samples were planned to be collected for the analysis of following hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, erythrocytes, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin and platelet count.
Time frame: Baseline (Day 1: Pre-dose) and up to 2 years
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Number of Participants With TEAEs and STEAEs
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Time frame: Up to 27 months
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Number of Participants With TEAEs Leading to Discontinuation
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Number of Participants With TEAEs Leading to Dose Reductions or Dose Delays
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Number of Participants With Vital Signs Any Decreases From Baseline According to Markedly Abnormal Criteria
Vital signs including SBP, DBP and pulse rate were planned to be measured in a semi-supine position after 5 minutes rest for the participants.
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Number of Participants With Vital Signs Any Increases From Baseline According to Markedly Abnormal Criteria
Vital signs including SBP, DBP, pulse rate and body temperature were planned to be measured in a semi-supine position after 5 minutes rest for the participants.
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Urine samples were planned to be collected for the analysis of following urine parameters: glucose, protein, occult blood, ketones, potential of hydrogen and specific gravity by dipstick method.
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091
Blood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091.
Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-dose
Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091 | Day 1, n=5,5,8,3,1 | 48.08 Hours*picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091 | Day 15, n=2,2,6,3,0 | 256.7 Hours*picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091 | Day 15, n=2,2,6,3,0 | 318.3 Hours*picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091 | Day 1, n=5,5,8,3,1 | 227.6 Hours*picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091 | Day 57, n=0,3,2,1,0 | 267.9 Hours*picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091 | Day 1, n=5,5,8,3,1 | 1804 Hours*picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091 | Day 15, n=2,2,6,3,0 | 1907 Hours*picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091 | Day 57, n=0,3,2,1,0 | 2027 Hours*picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091 | Day 15, n=2,2,6,3,0 | 3479 Hours*picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091 | Day 1, n=5,5,8,3,1 | 3615 Hours*picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091 | Day 57, n=0,3,2,1,0 | 3515 Hours*picogram per milliliter |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) GSK1795091 | Day 1, n=5,5,8,3,1 | 4166 Hours*picogram per milliliter |
Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091
Blood samples were collected at indicated time points for the determination of Cmax of GSK1795091.
Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-dose
Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 1, n=7,5,9,4,2 | 4.180 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 8, n=8,5,8,3,1 | 4.720 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 15, n=9,4,8,3,0 | 5.110 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 57, n=4,3,4,1,0 | 6.400 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 64, n=5,4,3,2,0 | 3.340 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 78, n=5,3,4,2,0 | 3.980 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 162, n=1,0,0,0,0 | 3.450 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 246, n=1,0,0,0,0 | 37.20 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 414, n=1,0,0,0,0 | 18.60 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 498, n=1,0,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 15, n=9,4,8,3,0 | 5.120 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 78, n=5,3,4,2,0 | 10.10 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 8, n=8,5,8,3,1 | 6.160 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 64, n=5,4,3,2,0 | 7.055 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 57, n=4,3,4,1,0 | 7.470 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 1, n=7,5,9,4,2 | 4.920 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 57, n=4,3,4,1,0 | 32.60 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 8, n=8,5,8,3,1 | 30.85 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 1, n=7,5,9,4,2 | 29.20 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 15, n=9,4,8,3,0 | 35.63 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 78, n=5,3,4,2,0 | 22.70 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 64, n=5,4,3,2,0 | 26.70 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 78, n=5,3,4,2,0 | 72.22 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 15, n=9,4,8,3,0 | 57.57 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 57, n=4,3,4,1,0 | 60.09 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 1, n=7,5,9,4,2 | 59.95 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 64, n=5,4,3,2,0 | 75.05 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 8, n=8,5,8,3,1 | 71.91 Picogram per milliliter |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 8, n=8,5,8,3,1 | 89.51 Picogram per milliliter |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Maximum Plasma Concentration (Cmax) of GSK1795091 | Day 1, n=7,5,9,4,2 | 82.18 Picogram per milliliter |
Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK3174998
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3174998. The presence of anti-GSK3174998 antibodies were assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 27 months
Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK3174998 | 5 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK3174998 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK3174998 | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK3174998 | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Number of Participants With Present Antidrug Antibody (ADA) Against GSK3174998 | 0 Participants |
Part 1a: Plasma Concentration of GSK1795091
Blood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091. Pharmacokinetic (PK) Population consisted of all participants from the All Treated population for whom a PK sample was obtained, analyzed, measurable, and valid.
Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Days 78, 162, 246, 414 and 498: 10 minutes post-dose
Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 24 hours, n=8,5,9,4,2 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 22: Pre-dose, n=9,3,7,3,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: Pre-dose, n=9,3,9,2,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 10 minutes, n=7,5,9,4,2 | 3.960 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 4 hours, n=8,5,9,4,2 | 3.680 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: Pre-dose, n=8,5,8,3,1 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: 24 hours, n=6,4,6,2,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: 4 hours, n=8,5,7,2,1 | 3.190 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: Pre-dose, n=6,3,6,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 78: 10 minutes, n=5,3,4,2,0 | 3.980 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: 10 minutes, n=9,5,8,3,1 | 4.300 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: 24 hours, n=9,3,8,3,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 246: 10 minutes, n=1,0,0,0,0 | 37.200 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 64: Pre-dose, n=4,4,4,1,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: 4 hours, n=4,3,6,1,0 | 3.855 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: 4 hours, n=9,3,6,3,0 | 2.830 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: 10 minutes, n=4,3,4,1,0 | 6.400 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 64: 10 minutes, n=5,4,3,2,0 | 3.340 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 2 hours, n=8,5,9,4,2 | 1.580 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: Pre-dose, n=9,5,9,4,2 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 162: 10 minutes, n=1,0,0,0,0 | 3.450 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 6 hours, n=8,3,9,4,1 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: 10 minutes, n=8,4,8,3,0 | 5.255 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 498: 10 minutes, n=1,0,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 414: 10 minutes, n=1,0,0,0,0 | 18.600 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: Pre-dose, n=6,3,6,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: 10 minutes, n=4,3,4,1,0 | 7.470 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: 4 hours, n=4,3,6,1,0 | 3.530 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: 24 hours, n=6,4,6,2,0 | 2.665 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 4 hours, n=8,5,9,4,2 | 3.680 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 64: Pre-dose, n=4,4,4,1,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 6 hours, n=8,3,9,4,1 | 3.470 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 24 hours, n=8,5,9,4,2 | 2.190 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 78: 10 minutes, n=5,3,4,2,0 | 10.100 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: Pre-dose, n=8,5,8,3,1 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 10 minutes, n=7,5,9,4,2 | 4.920 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: 10 minutes, n=9,5,8,3,1 | 6.160 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: 4 hours, n=8,5,7,2,1 | 3.790 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: Pre-dose, n=9,5,9,4,2 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 64: 10 minutes, n=5,4,3,2,0 | 7.055 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: Pre-dose, n=9,3,9,2,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: 10 minutes, n=8,4,8,3,0 | 5.120 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: 4 hours, n=9,3,6,3,0 | 4.210 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 2 hours, n=8,5,9,4,2 | 4.090 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: 24 hours, n=9,3,8,3,0 | 3.050 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 22: Pre-dose, n=9,3,7,3,0 | 0.000 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: 4 hours, n=4,3,6,1,0 | 13.735 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: Pre-dose, n=9,3,9,2,0 | 0.000 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 78: 10 minutes, n=5,3,4,2,0 | 22.700 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 6 hours, n=8,3,9,4,1 | 25.700 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: Pre-dose, n=6,3,6,0,0 | 1.215 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: 10 minutes, n=8,4,8,3,0 | 35.625 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: 4 hours, n=9,3,6,3,0 | 25.675 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 4 hours, n=8,5,9,4,2 | 27.300 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 64: Pre-dose, n=4,4,4,1,0 | 3.040 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 22: Pre-dose, n=9,3,7,3,0 | 0.000 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: Pre-dose, n=9,5,9,4,2 | 0.000 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: 24 hours, n=6,4,6,2,0 | 16.595 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: 10 minutes, n=9,5,8,3,1 | 30.850 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 10 minutes, n=7,5,9,4,2 | 28.800 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 64: 10 minutes, n=5,4,3,2,0 | 26.700 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: Pre-dose, n=8,5,8,3,1 | 0.000 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: 10 minutes, n=4,3,4,1,0 | 32.600 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: 4 hours, n=8,5,7,2,1 | 16.000 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: 24 hours, n=9,3,8,3,0 | 18.970 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 2 hours, n=8,5,9,4,2 | 29.200 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 24 hours, n=8,5,9,4,2 | 15.800 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 64: Pre-dose, n=4,4,4,1,0 | 15.300 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: Pre-dose, n=9,5,9,4,2 | 0.000 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 10 minutes, n=7,5,9,4,2 | 56.330 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 2 hours, n=8,5,9,4,2 | 57.195 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 4 hours, n=8,5,9,4,2 | 47.315 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 6 hours, n=8,3,9,4,1 | 46.040 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 24 hours, n=8,5,9,4,2 | 35.265 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: Pre-dose, n=8,5,8,3,1 | 4.590 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: 10 minutes, n=9,5,8,3,1 | 71.910 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: 4 hours, n=8,5,7,2,1 | 61.830 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: Pre-dose, n=9,3,9,2,0 | 4.975 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: 10 minutes, n=8,4,8,3,0 | 57.570 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: 4 hours, n=9,3,6,3,0 | 50.950 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 15: 24 hours, n=9,3,8,3,0 | 41.770 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 22: Pre-dose, n=9,3,7,3,0 | 4.450 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: 10 minutes, n=4,3,4,1,0 | 60.090 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: 4 hours, n=4,3,6,1,0 | 55.980 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 57: 24 hours, n=6,4,6,2,0 | 51.390 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 64: 10 minutes, n=5,4,3,2,0 | 75.045 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 78: 10 minutes, n=5,3,4,2,0 | 72.215 Picogram per milliliter |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 10 minutes, n=7,5,9,4,2 | 82.175 Picogram per milliliter |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: Pre-dose, n=8,5,8,3,1 | 4.160 Picogram per milliliter |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 24 hours, n=8,5,9,4,2 | 39.120 Picogram per milliliter |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 6 hours, n=8,3,9,4,1 | 57.180 Picogram per milliliter |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: Pre-dose, n=9,5,9,4,2 | 0.000 Picogram per milliliter |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 4 hours, n=8,5,9,4,2 | 60.945 Picogram per milliliter |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 1: 2 hours, n=8,5,9,4,2 | 62.285 Picogram per milliliter |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: 4 hours, n=8,5,7,2,1 | 65.030 Picogram per milliliter |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Plasma Concentration of GSK1795091 | Day 8: 10 minutes, n=9,5,8,3,1 | 89.510 Picogram per milliliter |
Part 1a: Predose Concentration (Cpre) of GSK1795091
Blood samples were collected at indicated time points for the determination of Cpre of GSK1795091.
Time frame: Days 1, 8, 15, 22, 57, 64, 78, 162, 246, 414 and 498: Pre-dose
Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 22, n=9,3,7,3,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 8, n=8,5,8,3,1 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 64, n=4,4,4,1,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 57, n=4,3,4,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 15, n=9,3,8,2,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 64, n=4,4,4,1,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 22, n=9,3,7,3,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 57, n=4,3,4,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 8, n=8,5,8,3,1 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 15, n=9,3,8,2,0 | 0.000 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 8, n=8,5,8,3,1 | 0.000 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 57, n=4,3,4,0,0 | 1.215 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 22, n=9,3,7,3,0 | 0.000 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 15, n=9,3,8,2,0 | 0.000 Picogram per milliliter |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 64, n=4,4,4,1,0 | 3.040 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 64, n=4,4,4,1,0 | 15.30 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 8, n=8,5,8,3,1 | 4.590 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 15, n=9,3,8,2,0 | 4.975 Picogram per milliliter |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 22, n=9,3,7,3,0 | 4.450 Picogram per milliliter |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 8, n=8,5,8,3,1 | 4.160 Picogram per milliliter |
| Unknown | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 498, n=0,0,0,0,0 | — Picogram per milliliter |
| Unknown | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 414, n=0,0,0,0,0 | — Picogram per milliliter |
| Unknown | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 246, n=0,0,0,0,0 | — Picogram per milliliter |
| Unknown | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 162, n=0,0,0,0,0 | — Picogram per milliliter |
| Unknown | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 78, n=0,0,0,0,0 | — Picogram per milliliter |
| Unknown | Part 1a: Predose Concentration (Cpre) of GSK1795091 | Day 1, n=0,0,0,0,0 | — Picogram per milliliter |
Part 1b: AUC(0-tau) GSK1795091
Blood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091.
Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose
Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: AUC(0-tau) GSK1795091 | Day 1, n=4,4,0,0,0 | 819.1 Hours*picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: AUC(0-tau) GSK1795091 | Day 15, n=3,2,0,0,0 | 661.9 Hours*picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: AUC(0-tau) GSK1795091 | Day 57, n=1,2,0,0,0 | 845.2 Hours*picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: AUC(0-tau) GSK1795091 | Day 1, n=4,4,0,0,0 | 1840 Hours*picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: AUC(0-tau) GSK1795091 | Day 15, n=3,2,0,0,0 | 1453 Hours*picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: AUC(0-tau) GSK1795091 | Day 57, n=1,2,0,0,0 | 1757 Hours*picogram per milliliter |
Part 1b: Cmax of GSK1795091
Blood samples were collected at indicated time points for the determination of Cmax of GSK1795091.
Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose
Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cmax of GSK1795091 | Day 64, n=2,2,0,0,0 | 6.910 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cmax of GSK1795091 | Day 8, n=5,4,0,0,0 | 15.28 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cmax of GSK1795091 | Day 57, n=3,2,0,0,0 | 14.62 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cmax of GSK1795091 | Day 15, n=4,4,0,0,0 | 16.00 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cmax of GSK1795091 | Day 1, n=6,5,0,0,0 | 14.95 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cmax of GSK1795091 | Day 78, n=2,2,0,0,0 | 6.980 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cmax of GSK1795091 | Day 1, n=6,5,0,0,0 | 32.30 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cmax of GSK1795091 | Day 57, n=3,2,0,0,0 | 28.16 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cmax of GSK1795091 | Day 15, n=4,4,0,0,0 | 27.80 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cmax of GSK1795091 | Day 78, n=2,2,0,0,0 | 34.88 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cmax of GSK1795091 | Day 8, n=5,4,0,0,0 | 29.55 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cmax of GSK1795091 | Day 64, n=2,2,0,0,0 | 34.35 Picogram per milliliter |
Part 1b: Cpre of GSK1795091
Blood samples were collected at indicated time points for the determination of Cpre of GSK1795091.
Time frame: Days 1, 8, 15, 22, 57, 64 and 78: Pre-dose
Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cpre of GSK1795091 | Day 15, n=4,3,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cpre of GSK1795091 | Day 57, n=3,1,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cpre of GSK1795091 | Day 22, n=5,2,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cpre of GSK1795091 | Day 8, n=5,4,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cpre of GSK1795091 | Day 64, n=1,2,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cpre of GSK1795091 | Day 15, n=4,3,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cpre of GSK1795091 | Day 64, n=1,2,0,0,0 | 1.875 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cpre of GSK1795091 | Day 8, n=5,4,0,0,0 | 2.215 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cpre of GSK1795091 | Day 22, n=5,2,0,0,0 | 1.015 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Cpre of GSK1795091 | Day 57, n=3,1,0,0,0 | 2.300 Picogram per milliliter |
| Unknown | Part 1b: Cpre of GSK1795091 | Day 78, n=0,0,0,0,0 | — Picogram per milliliter |
| Unknown | Part 1b: Cpre of GSK1795091 | Day 1, n=0,0,0,0,0 | — Picogram per milliliter |
Part 1b: Number of Participants With the Present ADA Against GSK3359609
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to GSK3359609. The presence of anti-GSK3359609 antibodies were assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 27 months
Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Number of Participants With the Present ADA Against GSK3359609 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Number of Participants With the Present ADA Against GSK3359609 | 1 Participants |
Part 1b: Plasma Concentration of GSK1795091
Blood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091.
Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose
Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1b as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 1: Pre-dose, n=6,5,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 1: 10 minutes, n=6,5,0,0,0 | 12.870 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 1: 2 hours, n=6,5,0,0,0 | 14.100 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 1: 4 hours, n=6,5,0,0,0 | 13.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 1: 6 hours, n=6,4,0,0,0 | 12.065 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 1: 24 hours, n=6,4,0,0,0 | 7.680 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 8: Pre-dose, n=5,4,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 8: 10 minutes, n=5,4,0,0,0 | 15.280 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 8: 4 hours, n=5,4,0,0,0 | 11.460 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 15: Pre-dose, n=4,3,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 15: 10 minutes, n=4,4,0,0,0 | 16.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 15: 4 hours, n=4,4,0,0,0 | 10.145 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 15: 24 hours, n=5,2,0,0,0 | 6.890 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 22: Pre-dose, n=5,2,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 57: Pre-dose, n=3,1,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 57: 10 minutes, n=3,2,0,0,0 | 14.620 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 57: 4 hours, n=1,1,0,0,0 | 12.140 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 57: 24 hours, n=3,2,0,0,0 | 8.250 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 64: Pre-dose, n=1,2,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 64: 10 minutes, n=2,2,0,0,0 | 6.910 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 78: 10 minutes, n=2,2,0,0,0 | 6.980 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 15: 10 minutes, n=4,4,0,0,0 | 27.645 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 1: Pre-dose, n=6,5,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 64: Pre-dose, n=1,2,0,0,0 | 1.875 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 1: 10 minutes, n=6,5,0,0,0 | 32.300 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 15: 4 hours, n=4,4,0,0,0 | 24.100 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 1: 2 hours, n=6,5,0,0,0 | 29.770 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 57: 4 hours, n=1,1,0,0,0 | 25.510 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 1: 4 hours, n=6,5,0,0,0 | 25.330 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 15: 24 hours, n=5,2,0,0,0 | 14.735 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 1: 6 hours, n=6,4,0,0,0 | 23.690 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 78: 10 minutes, n=2,2,0,0,0 | 34.875 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 1: 24 hours, n=6,4,0,0,0 | 19.650 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 22: Pre-dose, n=5,2,0,0,0 | 1.015 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 8: Pre-dose, n=5,4,0,0,0 | 2.215 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 57: 24 hours, n=3,2,0,0,0 | 17.530 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 8: 10 minutes, n=5,4,0,0,0 | 29.550 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 57: Pre-dose, n=3,1,0,0,0 | 2.300 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 8: 4 hours, n=5,4,0,0,0 | 23.850 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 64: 10 minutes, n=2,2,0,0,0 | 34.345 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 15: Pre-dose, n=4,3,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1b: Plasma Concentration of GSK1795091 | Day 57: 10 minutes, n=3,2,0,0,0 | 28.155 Picogram per milliliter |
Part 1c: AUC(0-tau) GSK1795091
Blood samples were collected at indicated time points for the determination of AUC(0-tau) of GSK1795091.
Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose
Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: AUC(0-tau) GSK1795091 | Day 1, n=4,5,0,0,0 | 851.7 Hours*picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: AUC(0-tau) GSK1795091 | Day 15, n=3,2,0,0,0 | 566.9 Hours*picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: AUC(0-tau) GSK1795091 | Day 57, n=2,1,0,0,0 | 778.0 Hours*picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: AUC(0-tau) GSK1795091 | Day 1, n=4,5,0,0,0 | 1611 Hours*picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: AUC(0-tau) GSK1795091 | Day 15, n=3,2,0,0,0 | 1189 Hours*picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: AUC(0-tau) GSK1795091 | Day 57, n=2,1,0,0,0 | 1640 Hours*picogram per milliliter |
Part 1c: Cmax of GSK1795091
Blood samples were collected at indicated time points for the determination of Cmax of GSK1795091.
Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose
Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cmax of GSK1795091 | Day 1, n=6,6,0,0,0 | 13.75 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cmax of GSK1795091 | Day 8, n=6,5,0,0,0 | 13.53 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cmax of GSK1795091 | Day 15, n=6,6,0,0,0 | 10.19 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cmax of GSK1795091 | Day 57, n=2,1,0,0,0 | 14.67 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cmax of GSK1795091 | Day 64, n=3,1,0,0,0 | 13.57 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cmax of GSK1795091 | Day 78, n=2,0,0,0,0 | 15.46 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cmax of GSK1795091 | Day 1, n=6,6,0,0,0 | 30.56 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cmax of GSK1795091 | Day 64, n=3,1,0,0,0 | 31.68 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cmax of GSK1795091 | Day 8, n=6,5,0,0,0 | 25.35 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cmax of GSK1795091 | Day 57, n=2,1,0,0,0 | 23.84 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cmax of GSK1795091 | Day 15, n=6,6,0,0,0 | 28.02 Picogram per milliliter |
Part 1c: Cpre of GSK1795091
Blood samples were collected at indicated time points for the determination of Cpre of GSK1795091.
Time frame: Days 1, 8, 15, 22, 57, 64 and 78: Pre-dose
Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cpre of GSK1795091 | Day 8, n=5,5,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cpre of GSK1795091 | Day 22, n=3,3,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cpre of GSK1795091 | Day 64, n=2,1,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cpre of GSK1795091 | Day 57, n=2,1,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cpre of GSK1795091 | Day 15, n=3,4,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cpre of GSK1795091 | Day 64, n=2,1,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cpre of GSK1795091 | Day 8, n=5,5,0,0,0 | 2.060 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cpre of GSK1795091 | Day 15, n=3,4,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cpre of GSK1795091 | Day 22, n=3,3,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Cpre of GSK1795091 | Day 57, n=2,1,0,0,0 | 0.000 Picogram per milliliter |
| Unknown | Part 1c: Cpre of GSK1795091 | Day 78, n=0,0,0,0,0 | — Picogram per milliliter |
| Unknown | Part 1c: Cpre of GSK1795091 | Day 1, n=0,0,0,0,0 | — Picogram per milliliter |
Part 1c: Number of Participants With the Present ADA Against Pembrolizumab
Serum samples were collected at indicated time points for the presence of antibodies that bind to pembrolizumab. The presence of anti-pembrolizumab antibodies were planned to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 27 months
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Samples were collected but will not be analyzed for the presence of anti-pembrolizumab antibodies as pembrolizumab immunogenicity has been previously characterized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Number of Participants With the Present ADA Against Pembrolizumab | NA Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Number of Participants With the Present ADA Against Pembrolizumab | NA Participants |
Part 1c: Plasma Concentration of GSK1795091
Blood samples were collected at indicated time points for the determination of plasma concentration of GSK1795091.
Time frame: Day 1: Pre-dose, 10 minutes, 2, 4, 6, 24 hours; Day 8: Pre-dose, 10 minutes, 4 hours; Days 15 and 57: Pre-dose, 10 minutes, 4, 24 hours; Day 22: Pre-dose; Day 64: Pre-dose, 10 minutes; Day 78: 10 minutes post-dose
Population: PK Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Part 1c as no participants were enrolled. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 78: 10 minutes, n=2,0,0,0,0 | 15.455 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 1: 2 hours, n=6,6,0,0,0 | 11.475 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 1: 4 hours, n=7,6,0,0,0 | 9.890 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 1: 6 hours, n=7,6,0,0,0 | 9.460 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 1: 24 hours, n=7,6,0,0,0 | 8.370 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 8: Pre-dose, n=6,5,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 8: 10 minutes, n=7,5,0,0,0 | 12.810 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 8: 4 hours, n=6,5,0,0,0 | 9.420 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 15: Pre-dose, n=3,4,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 15: 10 minutes, n=7,6,0,0,0 | 9.200 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 15: 4 hours, n=7,4,0,0,0 | 7.070 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 15: 24 hours, n=7,5,0,0,0 | 4.580 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 22: Pre-dose, n=4,3,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 57: Pre-dose, n=2,1,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 57: 10 minutes, n=2,1,0,0,0 | 14.665 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 57: 4 hours, n=2,0,0,0,0 | 10.515 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 57: 24 hours, n=2,2,0,0,0 | 7.460 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 64: Pre-dose, n=2,1,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 64: 10 minutes, n=3,1,0,0,0 | 13.570 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 1: Pre-dose, n=7,6,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 1: 10 minutes, n=7,6,0,0,0 | 13.600 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 1: Pre-dose, n=7,6,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 57: Pre-dose, n=2,1,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 1: 10 minutes, n=7,6,0,0,0 | 27.965 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 15: 10 minutes, n=7,6,0,0,0 | 28.015 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 1: 2 hours, n=6,6,0,0,0 | 28.775 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 57: 24 hours, n=2,2,0,0,0 | 9.780 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 1: 4 hours, n=7,6,0,0,0 | 25.970 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 15: 4 hours, n=7,4,0,0,0 | 17.825 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 1: 6 hours, n=7,6,0,0,0 | 24.415 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 57: 10 minutes, n=2,1,0,0,0 | 23.840 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 1: 24 hours, n=7,6,0,0,0 | 15.825 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 15: 24 hours, n=7,5,0,0,0 | 11.230 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 8: Pre-dose, n=6,5,0,0,0 | 2.060 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 64: 10 minutes, n=3,1,0,0,0 | 31.680 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 8: 10 minutes, n=7,5,0,0,0 | 24.260 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 22: Pre-dose, n=4,3,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 8: 4 hours, n=6,5,0,0,0 | 23.390 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 64: Pre-dose, n=2,1,0,0,0 | 0.000 Picogram per milliliter |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1c: Plasma Concentration of GSK1795091 | Day 15: Pre-dose, n=3,4,0,0,0 | 0.000 Picogram per milliliter |
Part 1: Disease Control Rate
Disease control rate is defined as the percentage of participants with a confirmed best overall response of CR or PR or at least 12 weeks of stable disease per RECIST v 1.1.
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Disease Control Rate | 44.4 Percentage of participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Disease Control Rate | 33.3 Percentage of participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Disease Control Rate | 33.3 Percentage of participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Disease Control Rate | 25.0 Percentage of participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Disease Control Rate | 0.0 Percentage of participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Disease Control Rate | 16.7 Percentage of participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Disease Control Rate | 20.0 Percentage of participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Disease Control Rate | 14.3 Percentage of participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Disease Control Rate | 33.3 Percentage of participants |
Part 1: Duration of Response
Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve an overall response (that is., a confirmed best overall response of CR or PR) by RECIST v 1.1.
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled. Values are presented based on the Kaplan-Meier analysis. Only participants with CR or PR are included in analysis. For arms with N=0, duration of response could not be calculated as no participants had a confirmed CR or PR with in these arms.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Duration of Response | 13.73 Months |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Duration of Response | NA Months |
Part 1: Objective Response Rate
Objective response rate is defined as the percentage of participants achieving a confirmed best overall response of complete response (CR) or partial response (PR) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Objective Response Rate | 11.1 Percentage of participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Objective Response Rate | 0.0 Percentage of participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Objective Response Rate | 0.0 Percentage of participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Objective Response Rate | 0.0 Percentage of participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Objective Response Rate | 0.0 Percentage of participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Objective Response Rate | 0.0 Percentage of participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Objective Response Rate | 0.0 Percentage of participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Objective Response Rate | 0.0 Percentage of participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Objective Response Rate | 33.3 Percentage of participants |
Part 1: Overall Survival
Overall survival is defined as time from the date of first dose of study treatment (whichever investigational drug administered first) to the date of death due to any cause.
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled. Values are presented based on the Kaplan-Meier analysis. All participants (overall population) were included in analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Overall Survival | 9.03 Months |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Overall Survival | 7.75 Months |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Overall Survival | 16.69 Months |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Overall Survival | 6.72 Months |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Overall Survival | 11.14 Months |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Overall Survival | 4.48 Months |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Overall Survival | 2.89 Months |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Overall Survival | 3.91 Months |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Overall Survival | NA Months |
Part 1: Progression-free Survival
Progression-free survival is defined as the interval of time (in months) between the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest. PFS was determined according to RECIST version 1.1. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled. Values are presented based on the Kaplan-Meier analysis. All participants (overall population) were included in analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Progression-free Survival | 2.79 Months |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Progression-free Survival | 3.29 Months |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Progression-free Survival | 2.60 Months |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Progression-free Survival | 2.25 Months |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Progression-free Survival | NA Months |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Progression-free Survival | 2.28 Months |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Progression-free Survival | 1.41 Months |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Progression-free Survival | 2.22 Months |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Progression-free Survival | 2.37 Months |
Part 1: Time to Response
Time to response is defined as the time from the date of first dose to the date of the first documented evidence of response (PR or CR).
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled. Values are presented based on the Kaplan-Meier analysis. Only participants with CR or PR are included in analysis. For arms with N=0, time to response could not be calculated as no participants had a confirmed CR or PR with in these arms.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Time to Response | 5.6 Months |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Time to Response | 2.0 Months |
Part 2a: Number of Participants With the Present ADA Against GSK3174998
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to GSK3174998. The presence of anti-GSK3174998 antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2b: Number of Participants With the Present ADA Against GSK3359609
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to GSK3359609. The presence of anti-GSK3359609 antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2c: Number of Participants With the Present ADA Against Pembrolizumab
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to pembrolizumab. The presence of anti-pembrolizumab antibodies were were planeed to be assessed using a titered approach using validated immunoassays (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Disease Control Rate
Disease control rate is defined as the percentage of participants with a confirmed best overall response of CR or PR or at least 12 weeks of stable disease per RECIST v 1.1.
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Duration of Response
Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve an overall response (that is., a confirmed best overall response of CR or PR) by RECIST v 1.1.
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Objective Response Rate
Objective response rate is defined as the percentage of participants achieving a confirmed best overall response of CR or PR evaluated using RECIST v 1.1, where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Overall Survival
Overall survival is defined as time from the date of first dose of study treatment (whichever investigational drug administered first) to the date of death due to any cause.
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Progression-free Survival
Progression-free survival is defined as the interval of time (in months) between the date of first dose to the date of disease progression according to clinical or radiological assessment or death due to any causes, whichever occurs earliest by RECIST v 1.1. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Time to Response
Time to response is defined as the time from the date of first dose to the date of the first documented evidence of response (PR or CR).
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | TEAEs | 9 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | STEAEs | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | TEAEs | 6 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | STEAEs | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | TEAEs | 9 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | STEAEs | 5 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | TEAEs | 4 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | STEAEs | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | TEAEs | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | STEAEs | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | STEAEs | 2 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | TEAEs | 6 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | STEAEs | 2 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | TEAEs | 5 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | TEAEs | 5 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | STEAEs | 3 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | TEAEs | 6 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With TEAEs and STEAEs Until End of the Study | STEAEs | 2 Participants |
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
Blood samples were collected for the analysis of following chemistry parameters: albumin (Hypo), ALP, ALT, AST, bilirubin, calcium (Hyper and Hypo), creatinine, glucose (Hyper and Hypo), potassium (Hyper and Hypo) and sodium (Hyper and Hypo). The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for any worst-case on therapy any grade increase has been presented.
Time frame: Up to 2 years
Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | AST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 5 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 7 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Albumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Creatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Bilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Creatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Bilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Albumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | AST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Albumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | AST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Creatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Bilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Albumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | AST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Bilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Creatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Bilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | AST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Creatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Albumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Bilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Creatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Albumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | AST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Bilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | AST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Albumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Creatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Bilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Albumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | AST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Creatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Bilirubin: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALT: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hyper): n=9,6,9,4,2,0,0,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Creatinine: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | ALP: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Albumin (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Sodium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hyper): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Potassium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Calcium (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | Glucose (Hypo): n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters | AST: n=9,6,9,4,2,6,5,0,0,0,7,6,0,0,0 | 2 Participants |
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho) (Low), hemoglobin (Hb) (Low) and platelet count (PC). The laboratory parameters were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for any worst-case on therapy any grade increase has been presented.
Time frame: Up to 2 years
Population: All Treated Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Data was not collected for GSK1795091 150 ng, 200 ng and 250 ng arms of Parts 1b and 1c as no participants were enrolled.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 0 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 7 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 6 Participants |
| Part 1a: 50ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | PC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | PC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 0 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 3 Participants |
| Part 1a: 100ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 4 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 4 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | PC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1a: 150ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 0 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1a: 200ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | PC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 0 Participants |
| Part 1a: 250ng GSK1795091 + 24mg GSK3174998 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | PC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | PC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 0 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1b: 50ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 5 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | PC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1b: 100ng GSK1795091 + 80mg GSK3359609 | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | PC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 0 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 2 Participants |
| Part 1c: 50ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 0 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutro: n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 2 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | PC: n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 1 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hb (Low): n=9,6,9,4,2,6,4,0,0,0,7,6,0,0,0 | 3 Participants |
| Part 1c: 100ng GSK1795091 + 200mg Pembrolizumab | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lympho (Low): n=8,6,9,4,2,6,4,0,0,0,6,6,0,0,0 | 3 Participants |
Part 2: Number of Participants With TEAEs and STEAEs Until End of the Study
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement or associated with liver injury and impaired liver function. TEAEs are defined as adverse events that started or worsened in severity on or after the first dose of study medication.
Time frame: Up to 47 months and 13 days
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Chemistry Parameters
Blood samples were planned to be collected for the analysis of following chemistry parameters: albumin, ALP, ALT, AST, bilirubin, calcium, creatinine, glucose, potassium and sodium.
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Blood samples were planned to be collected for the analysis of following hematology parameters: neutrophils (Neutro), lymphocytes (lympho), hemoglobin (Hb) and platelet count (PC).
Time frame: Up to 2 years
Population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.