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GSK3739937Wiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
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There is one clinical trial.
Clinical Trials
1 A Double-Blind (Sponsor Unblinded), Randomized, Placebo-Controlled, Single and Repeated Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK3739937 in Healthy Participants
Human immunodeficiency virus 1 (HIV-1) infections continues to be a serious health threat throughout the world and development of medicines with new mechanism of action have an important role to play. The purpose of this study is to gain information on the safety, tolerability, and pharmacokinetic (PK) properties of GSK3739937. The information collected in this study will help in further clinical development of GSK3739937, including a Phase IIA Proof of Concept (PoC) study in HIV-infected participants as well as a FTIH study of long acting formulation of GSK3739937 administered parenterally (subcutaneously or intramuscularly). This randomized, placebo controlled, single and repeat-dose escalation study of GSK3739937 in healthy participants and will be executed in two-part. In Part 1 single ascending dose (SAD), approximately 18 participants will be randomized with approximately 9 participants within each of Cohort 1 and Cohort 2. In Part 2 multiple ascending dose (MAD), approximately 30 participants will be randomized with approximately 10 participants within each of Cohorts 3 to 5. Approximately 48 participants will be enrolled in the study and all doses will be administered after a moderate fat meal. Maximum duration of study participation will be approximately 22 weeks in Part 1 and approximately 18 weeks in Part 2.
NCT04493684 HIV Infections Drug: GSK3739937 Drug: Placebo MeSH:HIV Infections
Primary Outcomes
Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose: resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Measure: Part 1: Cohort 1-2: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Time: Up to Day 44Description: Blood samples will be collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets.
Measure: Part 1: Cohort 1-2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets (Giga cells per liter) Time: Baseline (Day -1) and up to Day 44Description: Blood samples will be collected to analyze the hematology parameters: RBC count.
Measure: Part 1: Cohort 1-2: Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) count (Trillion cells per liter) Time: Baseline (Day -1) and up to Day 44Description: Blood samples will be e collected to analyze the hematology parameters: MCV.
Measure: Part 1: Cohort 1-2: Change From Baseline in Hematology Parameters: Mean Corpuscular Volume (MCV) (Femtoliter) Time: Baseline (Day -1) and up to Day 44Description: Blood samples will be collected to analyze the hematology parameter: MCH.
Measure: Part 1: Cohort 1-2: Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (Picogram) Time: Baseline (Day -1) and up to Day 44Description: Blood samples will be collected to analyze the hematology parameter: hematocrit.
Measure: Part 1: Cohort 1-2: Change From Baseline in Hematology Parameter: Hematocrit (Proportion of red blood cells in blood) Time: Baseline (Day -1) and up to Day 44Description: Blood samples will be collected to analyze the hematology parameter: percent of reticulocytes.
Measure: Part 1: Cohort 1-2: Change From Baseline in Hematology Parameter: Percent of reticulocytes (Percentage of reticulocyte) Time: Baseline (Day -1) and up to Day 44Description: Blood samples will be collected to analyze the hematology parameter: Hb.
Measure: Part 1: Cohort 1-2: Change From Baseline in Hematology Parameter: Hemoglobin (Hb) (Grams per deciliter) Time: Baseline (Day -1) and up to Day 44Description: Blood samples will be collected to analyze the chemistry parameter: ALT, AST, and ALP.
Measure: Part 1: Cohort 1-2: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphate (ALP) (International units per Liter) Time: Baseline (Day -1) and up to Day 44Description: Blood samples will be collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, BUN, cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides.
Measure: Part 1:Cohort 1-2:Change from Baseline in bicarbonate,calcium,glucose,chloride,magnesium,phosphate,potassium,sodium,blood urea nitrogen (BUN),cholesterol,high density lipoprotein (HDL),low density lipoprotein (LDL),triglycerides (Millimole per Liter) Time: Baseline (Day -1) and up to Day 44Description: Blood samples will be collected to analyze the chemistry parameter: amylase and lipase
Measure: Part 1: Cohort 1-2: Change From Baseline in Clinical Chemistry Parameters : amylase and lipase (units per liter) Time: Baseline (Day -1) and up to Day 44Description: Blood samples will be collected to analyze the chemistry parameter: bilirubin, direct bilirubin and creatinine.
Measure: Part 1: Cohort 1-2: Change From Baseline in Clinical Chemistry Parameter: total bilirubin, direct Bilirubin and creatinine (Micromoles per Liter) Time: Baseline (Day -1) and up to Day 44Description: Blood samples will be collected to analyze the chemistry parameter: total protein.
Measure: Part 1: Cohort 1-2: Change From Baseline in Clinical Chemistry Parameter: total protein (Gram per Liter) Time: Baseline (Day -1) and up to Day 44Description: Urine samples will be collected at given time points to analyze the abnormal findings for potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
Measure: Part 1: Cohort 1-2: Number of Participants With Abnormal Urinalysis Time: Baseline (Day -1) and up to Day 44Description: SBP and DBP will be measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Measure: Part 1: Cohort 1-2: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (millimeters of mercury) Time: Baseline (Day -1) and up to Day 44Description: Pulse rate will be measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Measure: Part 1: Cohort 1-2: Change From Baseline in Vital Signs: Pulse Rate (Beats per minute) Time: Baseline (Day -1) and up to Day 44Description: Temperature was will be in semi-supine position after 5 minutes rest for the participants at indicated time points.
Measure: Part 1: Cohort 1-2: Change From Baseline in Vital Signs: Temperature (Degrees Celsius) Time: Baseline (Day -1) and up to Day 44Description: Respiratory rate will be measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Measure: Part 1: Cohort 1-2: Change From Baseline in Vital Sign: Respiratory Rate (Breaths per minute) Time: Baseline (Day -1) and up to Day 44Description: 12-lead ECGs will be measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant.
Measure: Part 1: Cohort 1-2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings Time: Baseline (Day 1, Pre-dose) and up to Day 44Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose: resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Measure: Part 2: Cohort 3-4: Number of Participants With AEs and SAEs Time: Up to Day 28Description: Blood samples will be collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets.
Measure: Part 2: Cohort 3-4:Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets (Giga cells per liter) Time: Baseline (Day -1) and up to Day 28Description: Blood samples will be collected to analyze the hematology parameters: RBC count.
Measure: Part 2: Cohort 3-4:Change From Baseline in Hematology Parameters: RBC count (Trillion cells per liter) Time: Baseline (Day -1) and up to Day 28Description: Blood samples will be collected to analyze the hematology parameters: MCV.
Measure: Part 2: Cohort 3-4: Change From Baseline in Hematology Parameters: MCV (Femtoliter) Time: Baseline (Day -1) and up to Day 28Description: Blood samples will be collected to analyze the hematology parameter: MCH.
Measure: Part 2: Cohort 3-4: Change From Baseline in Hematology Parameter: MCH (Picogram) Time: Baseline (Day -1) and up to Day 28Description: Blood samples will be collected to analyze the hematology parameter: hematocrit.
Measure: Part 2: Cohort 3-4: Change From Baseline in Hematology Parameter: Hematocrit (Proportion of red blood cells in blood) Time: Baseline (Day -1) and up to Day 28Description: Blood samples will be collected to analyze the hematology parameter: Percent of reticulocytes
Measure: Part 2: Cohort 3-4: Change From Baseline in Hematology Parameter: Percent of reticulocytes (Percentage reticulocyte) Time: Baseline (Day -1) and up to Day 28Description: Blood samples will be collected to analyze the hematology parameter: Hb.
Measure: Part 2: Cohort 3-4: Change From Baseline in Hematology Parameter: Hb (Grams per deciliter) Time: Baseline (Day -1) and up to Day 28Description: Blood samples will be e collected to analyze the chemistry parameter: ALT, AST and ALP.
Measure: Part 2: Cohort 3-4: Change From Baseline in Clinical Chemistry Parameter: ALT, AST and ALP (International units per Liter) Time: Baseline (Day -1) and up to Day 28Description: Blood samples will be collected to analyze the chemistry parameter: amylase and lipase
Measure: Part 2: Cohort 3-4: Change From Baseline in Clinical Chemistry Parameters : amylase and lipase (units per liter) Time: Baseline (Day -1) and up to Day 28Description: Blood samples will be collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, BUN, cholesterol, HDL, LDL and triglycerides.
Measure: Part 2: Cohort 3-4: Change From Baseline in bicarbonate, glucose, calcium, chloride, magnesium, phosphate, potassium, sodium, BUN, cholesterol, HDL, LDL and triglycerides (Millimoles per liter) Time: Baseline (Day -1) and up to Day 28Description: Blood samples will be collected to analyze the chemistry parameter: bilirubin, creatinine and direct bilirubin
Measure: Part 2: Cohort 3-4: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinin and Direct Bilirubin (Micromoles per liter) Time: Baseline (Day -1) and up to Day 28Description: Blood samples will be collected to analyze the chemistry parameter: total protein.
Measure: Part 2: Cohort 3-4: Change From Baseline in Clinical Chemistry Parameter: Total protein (Grams per liter) Time: Baseline (Day -1) and up to Day 28Description: Urine samples collected at given time points to analyze the abnormal findings for pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
Measure: Part 2: Cohort 3-4: Number of Participants With Abnormal Urinalysis Time: Baseline (Day -1) and up to Day 28Description: SBP and DBP measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Measure: Part 2: Cohort 3-4: Change From Baseline in Vital Signs: DBP and SBP (Millimeters of mercury) Time: Baseline (Day -1) and up to Day 28Description: Pulse rate will be measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Measure: Part 2: Cohort 3-4: Change From Baseline in Vital Signs: Pulse Rate (Beats per minute) Time: Baseline (Day -1) and up to Day 28Description: Temperature will be measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Measure: Part 2: Cohort 3-4: Change From Baseline in Vital Signs: Temperature (Degrees Celsius) Time: Baseline (Day -1) and up to Day 28Description: Respiratory rate will be measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Measure: Part 2: Cohort 3-4: Change From Baseline in Vital Sign: Respiratory Rate (Breaths per minute) Time: Baseline (Day -1) and up to Day 28Description: 12-lead ECGs will be measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant.
Measure: Part 2: Cohort 3-4: Number of Participants With Abnormal ECG Findings Time: Baseline (Day -1) and up to Day 28Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose: resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Measure: Part 2: Cohort 5: Number of Participants With AEs and SAEs Time: Up to Day 42Description: Blood samples will be collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets.
Measure: Part 2: Cohort 5:Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets (Giga cells per liter) Time: Baseline (Day -1) and up to Day 42Description: Blood samples will be collected to analyze the hematology parameters: RBC count
Measure: Part 2: Cohort 5: Change From Baseline in Hematology Parameters: RBC count (Trillion cells per liter) Time: Baseline (Day -1) and up to Day 42Description: Blood samples will be collected to analyze the hematology parameters: MCV.
Measure: Part 2: Cohort 5: Change From Baseline in Hematology Parameters: MCV (Femtoliter) Time: Baseline (Day -1) and up to Day 42Description: Blood samples will be collected to analyze the hematology parameter: MCH.
Measure: Part 2: Cohort 5: Change From Baseline in Hematology Parameter: MCH (Picogram) Time: Baseline (Day -1) and up to Day 42Description: Blood samples will be collected to analyze the hematology parameter: hematocrit.
Measure: Part 2: Cohort 5: Change From Baseline in Hematology Parameter: Hematocrit (Proportion of red blood cells in blood) Time: Baseline (Day -1) and up to Day 42Description: Blood samples will be collected to analyze the hematology parameter: Percent of reticulocytes
Measure: Part 2: Cohort 5: Change From Baseline in Hematology Parameter: Percent of reticulocytes (Percentage reticulocyte) Time: Baseline (Day -1) and up to Day 42Description: Blood samples will be collected to analyze the hematology parameter: Hb.
Measure: Part 2: Cohort 5: Change From Baseline in Hematology Parameter: Hb (Grams per deciliter) Time: Baseline (Day -1) and up to Day 42Description: Blood samples will be e collected to analyze the chemistry parameter: ALT, AST, and ALP.
Measure: Part 2: Cohort 5: Change From Baseline in Clinical Chemistry Parameter: ALT, AST, ALP (International units per Liter) Time: Baseline (Day -1) and up to Day 42Description: Blood samples will be collected to analyze the chemistry parameter: amylase and lipase
Measure: Part 2: Cohort 5: Change From Baseline in Clinical Chemistry Parameters : amylase and lipase (Units per liter) Time: Baseline (Day -1) and up to Day 42Description: Blood samples will be collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, BUN, cholesterol, HDL, LDL, and triglycerides.
Measure: Part 2: Cohort 5:Change From Baseline in Bicarbonate, glucose (non-fasting), Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides (Millimoles per liter) Time: Baseline (Day -1) and up to Day 42Description: Blood samples will be collected to analyze the chemistry parameter: bilirubin, creatinine and direct bilirubin
Measure: Part 2: Cohort 5: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine and Direct Bilirubin (Micromoles per liter) Time: Baseline (Day -1) and up to Day 42Description: Blood samples will be collected to analyze the chemistry parameter: total protein.
Measure: Part 2: Cohort 5: Change From Baseline in Clinical Chemistry Parameter: Total protein (Grams per liter) Time: Baseline (Day -1) and up to Day 42Description: Urine samples collected at given time points to analyze the abnormal findings for pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
Measure: Part 2: Cohort 5: Number of Participants With Abnormal Urinalysis Time: Baseline (Day -1) and up to Day 42Description: SBP and DBP measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Measure: Part 2: Cohort 5: Change From Baseline in Vital Signs: DBP and SBP (Millimeters of mercury) Time: Baseline (Day -1) and up to Day 42Description: Pulse rate will be measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Measure: Part 2: Cohort 5: Change From Baseline in Vital Signs: Pulse Rate (Beats per minute) Time: Baseline (Day -1) and up to Day 42Description: Temperature will be measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Measure: Part 2: Cohort 5: Change From Baseline in Vital Signs: Temperature (Degrees Celsius) Time: Baseline (Day -1) and up to Day 42Description: Respiratory rate will be measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Measure: Part 2: Cohort 5: Change From Baseline in Vital Sign: Respiratory Rate (Breaths per minute) Time: Baseline (Day -1) and up to Day 42Description: 12-lead ECGs will be measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant.
Measure: Part 2: Cohort 5: Number of Participants With Abnormal ECG Findings Time: Baseline (Day -1) and up to Day 42Secondary Outcomes
Description: Blood samples will be collected at indicated time points for the analysis of AUC(0-24) of GSK3739937.
Measure: Part 1: Cohort 1-2:Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 hours (AUC[0-24]) of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 and 24 hours post-doseDescription: Blood samples will be collected at indicated time points for the PK analysis of AUC(0-t) of GSK3739937.
Measure: Part 1: Cohort 1-2: AUC From zero (pre-dose) to t (AUC [0-t]) of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-doseDescription: Blood samples will be collected at indicated time points for the analysis of AUC(0-inf) of GSK3739937.
Measure: Part 1: Cohort 1-2: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-doseDescription: Blood samples will be collected at indicated time points for the analysis of T1/2 of GSK3739937.
Measure: Part 1: Cohort 1-2: Apparent Terminal Phase Half-life (T1/2) of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-doseDescription: Blood samples will be collected at indicated time points for the analysis of CL/F of GSK3739937.
Measure: Part 1: Cohort 1-2: Apparent Oral Clearance (CL/F) of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-doseDescription: Blood samples will be collected at indicated time points for the analysis of Cmax of GSK3739937.
Measure: Part 1: Cohort 1-2: Maximum Observed Concentration (Cmax) of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-doseDescription: Blood samples will be collected at indicated time points for the analysis of C24 of GSK3739937.
Measure: Part 1: Cohort 1-2: Concentration of GSK3739937 at 24 Hours (C24) of GSK3739937 Time: At 24 hours post-doseDescription: Blood samples will be collected at indicated time points for the analysis of Clast of GSK3739937.
Measure: Part 1: Cohort 1-2: Last Quantifiable Concentration (Clast) of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-doseDescription: Blood samples will be collected at indicated time points for the analysis of Tmax of GSK3739937.
Measure: Part 1: Cohort 1-2: Time of Occurrence of Cmax (Tmax) of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-doseDescription: Blood samples will be collected at indicated time points for the analysis of Tlag of GSK3739937.
Measure: Part 1: Cohort 1-2: Lag Time (Tlag) of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-doseDescription: Blood samples will be collected at indicated time points for the analysis of Tlast of GSK3739937.
Measure: Part 1: Cohort 1-2: Time to Reach Clast (Tlast) of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-doseDescription: Blood samples will be collected at indicated time points for the analysis of AUC(0-24) of GSK3739937.
Measure: Part 2: Cohort 3-4: AUC (0-24) of GSK3739937 on Day 1 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours post-dose on Day 1 (pre-dose on Day 2)Description: Blood samples will be collected at indicated time points for the analysis of Cmax of GSK3739937.
Measure: Part 2: Cohort 3-4: Cmax of GSK3739937 on Day 1 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours post-dose on Day 1 (pre-dose on Day 2)Description: Blood samples will be collected at indicated time points for the analysis of C24 of GSK3739937.
Measure: Part 2: Cohort 3-4: C24 of GSK3739937 on Day 1 Time: At 24 hours post-dose on Day 1 (pre-dose on Day 2)Description: Blood samples will be collected at indicated time points for the analysis of Tmax of GSK3739937.
Measure: Part 2: Cohort 3-4: Tmax of GSK3739937 on Day 1 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours post-dose on Day 1 (pre-dose on Day 2)Description: Blood samples will be collected at indicated time points for the analysis of Tlag of GSK3739937.
Measure: Part 2: Cohort 3-4: Tlag of GSK3739937 on Day 1 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours post-dose on Day 1 (pre-dose on Day 2)Description: Blood samples will be collected at indicated time points for the analysis of Tmax of GSK3739937.
Measure: Part 2: Cohort 3-4: Tmax of GSK3739937 on Day 14 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 14Description: Blood samples will be collected at indicated time points for the analysis of Cmax of GSK3739937.
Measure: Part 2: Cohort 3-4: Cmax of GSK3739937 on Day 14 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 14Description: Blood samples will be collected at indicated time points for the analysis of AUC(0-tau) of GSK3739937.
Measure: Part 2: Cohort 3-4: AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3739937 on Day 14 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours post-dose on Day 14Description: Blood samples will be collected at indicated time points for the analysis of Ctau of GSK3739937.
Measure: Part 2: Cohort 3-4: Plasma Trough Concentration (Ctau) of GSK3739937 on Day 14 Time: At 24 hours post-dose on Day 14Description: Blood samples will be collected at indicated time points for the analysis of T1/2 of GSK3739937.
Measure: Part 2: Cohort 3-4: T1/2 of GSK3739937 on Day 14 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours on Day 14Description: Blood samples will be collected at indicated time points for the analysis of CL/F of GSK3739937.
Measure: Part 2: Cohort 3-4: CL/F of GSK3739937 on Day 14 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours on Day 14Description: Blood samples will be collected at indicated time points for the analysis of Tmax of GSK3739937.
Measure: Part 2: Cohort 5: Tmax of GSK3739937 on Day 28 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 28Description: Blood samples will be collected at indicated time points for the analysis of Cmax of GSK3739937.
Measure: Part 2: Cohort 5: Cmax of GSK3739937 on Day 28 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 28Description: Blood samples will be collected at indicated time points for the analysis of AUC(0-tau) of GSK3739937.
Measure: Part 2: Cohort 5: AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]): Day 28 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 and 24 hours post-dose on Day 28Description: Blood samples will be collected at indicated time points for the analysis of Ctau of GSK3739937.
Measure: Part 2: Cohort 5: Plasma Trough Concentration (Ctau) of GSK3739937: Day 28 Time: At 24 hours post-dose on Day 28Description: Blood samples will be collected at indicated time points for the analysis of T1/2 of GSK3739937.
Measure: Part 2: Cohort 5:T1/2 of GSK3739937: Day 28 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 28Description: Blood samples will be collected at indicated time points for the analysis of CL/F of GSK3739937.
Measure: Part 2: Cohort 5: CL/F of GSK3739937: Day 28 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 28Description: Blood samples will be collected at indicated time points for the analysis of AUC(0-inf) Following Single Dose of GSK3739937.
Measure: Part 1: Cohort 1-2: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-doseDescription: Blood samples will be collected at indicated time points for the analysis of Cmax Following Single Dose of GSK3739937.
Measure: Part 1: Cohort 1-2: Dose Proportionality for Cmax Following Single Dose of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-doseDescription: Blood samples will be collected at indicated time points for the analysis of AUC(0-tau) Following Repeated Dose of GSK3739937.
Measure: Part 2: Cohort 3-4: Dose Proportionality (AUC0-tau) Following Repeated Dose of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, and 24 hours post-dose on Day 14Description: Blood samples will be collected at indicated time points for the analysis of AUC(0-tau) Following Repeated Dose of GSK3739937.
Measure: Part 2: Cohort 5: Dose Proportionality (AUC0-tau) Following Repeated Dose of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, and 24 hours post-dose on Day 28Description: Blood samples will be collected at indicated time points for the analysis of Ctrough Following Repeated Dose of GSK3739937.
Measure: Part 2: Cohort 3-4: Dose Proportionality (Ctrough) Following Repeated Dose of GSK3739937 Time: At 24 hours post-dose on Day 14Description: Blood samples will be collected at indicated time points for the analysis of Ctrough Following Repeated Dose of GSK3739937.
Measure: Part 2: Cohort 5: Dose Proportionality (Ctrough) Following Repeated Dose of GSK3739937 Time: At 24 hours post-dose on Day 28Description: Blood samples will be collected at indicated time points for the analysis of Cmax Following Repeated Dose of GSK3739937.
Measure: Part 2: Cohort 3-4: Dose Proportionality (Cmax) Following Repeated Dose of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, and 24 hours post-dose on Day 14Description: Blood samples will be collected at indicated time points for the analysis of Cmax Following Repeated Dose of GSK3739937.
Measure: Part 2: Cohort 5: Dose Proportionality (Cmax) Following Repeated Dose of GSK3739937 Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, and 24 hours post-dose on Day 28Description: Blood samples will be collected at indicated time points for the analysis of Predicted accumulation ratio Rp based on AUC.
Measure: Part 1: Cohort 1-2: Predicted accumulation ratio Rp based on AUC Time: Pre-dose (within 15 minutes prior to dosing) and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post-doseDescription: Blood samples will be collected at indicated time points for the analysis of accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]).
Measure: Part 2: Cohort 3-4: Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]) Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8,12 and 24 hours post-dose on Day 1 and Day 14Description: Blood samples will be collected at indicated time points for the analysis of accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]).
Measure: Part 2: Cohort 5: Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]) Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8,12 and 24 hours post-dose on Day 1 and Day 28Description: Blood samples will be collected at indicated time points for the analysis of accumulation Ratio of Cmax (R [CMAX]).
Measure: Part 2: Cohort 3-4: Accumulation Ratio of Cmax (R [CMAX]) Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8,12 and 24 hours post-dose on Day 1 and Day 14Description: Blood samples will be collected at indicated time points for the analysis of accumulation Ratio of Cmax (R [CMAX]).
Measure: Part 2: Cohort 5: Accumulation Ratio of Cmax (R [CMAX]) Time: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8,12 and 24 hours post-dose on Day 1 and Day 28Description: Blood samples will be collected at indicated time points for the analysis of accumulation Ratio of C(Tau) (R[CTAU]).
Measure: Part 2: Cohort 3-4: Accumulation Ratio of C(Tau) (R[CTAU]) Time: At 24 hours post-dose on Day 1 and Day 14Description: Blood samples will be collected at indicated time points for the analysis of accumulation Ratio of C(Tau) (R[CTAU]).
Measure: Part 2: Cohort 5: Accumulation Ratio of C(Tau) (R[CTAU]) Time: At 24 hours post-dose on Day 1 and Day 28Description: Blood samples will be collected at indicated time points for the analysis of pre-dose Concentration of GSK3739937.
Measure: Part 2: Cohort 3-4: Pre-dose Concentration of GSK3739937 from Day 2 to Day 14 Time: Pre-dose from Day 2 to Day 14Description: Blood samples will be collected at indicated time points for the analysis of Pre-dose Concentration of GSK3739937.
Measure: Part 2: Cohort 5: Pre-dose Concentration of GSK3739937 from Day 2 to Day 28 Time: Pre-dose from Day 2 to Day 28