Trial Outcomes & Findings for A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive Adults (NCT NCT03784079)

NCT ID: NCT03784079

Last Updated: 2021-02-16

Results Overview

Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. A HIV-1 RNA polymerase chain reaction (PCR) assay with a lower limit of detection (LLOD) of 50 copies per milliliter was used. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: Baseline (Day 1) and Day 11
• Results posted on: 2021-02-16

Participant Flow

This was a randomized, double-blind, placebo-controlled, adaptive clinical trial to evaluate the antiviral effect, safety, tolerability and pharmacokinetic (PK)/pharmacodynamics (PD) of GSK3640254 over 10 days in study Part 1 and over 7 days in study Part 2.

A total of 34 participants (14 participants in Part 1 and 20 participants in Part 2) were enrolled in this study. This study was conducted in France, Germany, Italy, South Africa and Spain.

Participant milestones

Measure	Part 1: GSK3640254 10 mg Participants received GSK3640254 10 milligram (mg), capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: GSK3640254 40 mg Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 80 mg Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Up to Day 24 STARTED	6	6	2	0	0	0	0
Part 1: Up to Day 24 COMPLETED	6	6	2	0	0	0	0
Part 1: Up to Day 24 NOT COMPLETED	0	0	0	0	0	0	0
Part 2: Up to Day 12 STARTED	0	0	0	6	6	6	2
Part 2: Up to Day 12 COMPLETED	0	0	0	6	6	6	2
Part 2: Up to Day 12 NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive Adults

Baseline characteristics by cohort

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: GSK3640254 40 mg n=6 Participants Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 80 mg n=6 Participants Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg n=6 Participants Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Total n=34 Participants Total of all reporting groups
Age, Customized <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants
Age, Customized 19-64 years	6 Participants n=93 Participants	6 Participants n=4 Participants	2 Participants n=27 Participants	6 Participants n=483 Participants	6 Participants n=36 Participants	6 Participants n=10 Participants	2 Participants n=115 Participants	34 Participants n=40 Participants
Age, Customized >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=40 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	6 Participants n=4 Participants	2 Participants n=27 Participants	5 Participants n=483 Participants	6 Participants n=36 Participants	5 Participants n=10 Participants	2 Participants n=115 Participants	32 Participants n=40 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	3 Participants n=40 Participants
Race/Ethnicity, Customized Asian: South East Asian Heritage	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=40 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	4 Participants n=40 Participants
Race/Ethnicity, Customized White: White/Caucasian/European Heritage	2 Participants n=93 Participants	5 Participants n=4 Participants	2 Participants n=27 Participants	5 Participants n=483 Participants	4 Participants n=36 Participants	5 Participants n=10 Participants	1 Participants n=115 Participants	24 Participants n=40 Participants
Race/Ethnicity, Customized Multiple: American Indian or Alaska Native & White	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=40 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 11

Population: Intent-To-Treat Exposed Population consisted of all participants who met study criteria and were enrolled into the study with documented evidence of having received at least 1 dose of treatment and at least one post-Baseline HIV-1 RNA measurement.

Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. A HIV-1 RNA polymerase chain reaction (PCR) assay with a lower limit of detection (LLOD) of 50 copies per milliliter was used. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11	-8605.8 Copies per milliliter Standard Deviation 4604.40	-100719.8 Copies per milliliter Standard Deviation 89182.99	-3406.5 Copies per milliliter Standard Deviation 2591.55	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 8

Population: Intent-To-Treat Exposed Population.

Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. An HIV-1 RNA PCR assay with an LLOD of 50 copies per milliliter was used. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Maximum Change From Baseline in Plasma HIV-1 RNA at Day 8	-48655.0 Copies per milliliter Standard Deviation 26269.41	-37904.3 Copies per milliliter Standard Deviation 38814.54	-64904.2 Copies per milliliter Standard Deviation 83798.67	-123478.5 Copies per milliliter Standard Deviation 175276.92	—

SECONDARY outcome

Timeframe: Up to Day 24

Population: Safety Population.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE 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 other situations as per Medical or scientific judgment. Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Non-SAEs	3 Participants	5 Participants	0 Participants	—	—
Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) SAEs	1 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to Day 12

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE 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 other situations as per Medical or scientific judgment.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Number of Participants With Non-SAEs and SAEs Non-SAEs	5 Participants	4 Participants	4 Participants	0 Participants	—
Part 2: Number of Participants With Non-SAEs and SAEs SAEs	0 Participants	0 Participants	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Basophils	0.005 10^9 cells per liter Standard Deviation 0.0266	-0.017 10^9 cells per liter Standard Deviation 0.0234	0.015 10^9 cells per liter Standard Deviation 0.0212	—	—
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Eosinophils	-0.023 10^9 cells per liter Standard Deviation 0.1296	0.058 10^9 cells per liter Standard Deviation 0.1134	-0.025 10^9 cells per liter Standard Deviation 0.0212	—	—
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Monocytes	0.100 10^9 cells per liter Standard Deviation 0.1124	-0.000 10^9 cells per liter Standard Deviation 0.0980	0.055 10^9 cells per liter Standard Deviation 0.0212	—	—
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Lymphocytes	-0.027 10^9 cells per liter Standard Deviation 0.5267	0.458 10^9 cells per liter Standard Deviation 0.4412	0.070 10^9 cells per liter Standard Deviation 0.0566	—	—
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Neutrophils	-0.045 10^9 cells per liter Standard Deviation 0.4624	-0.525 10^9 cells per liter Standard Deviation 0.8169	0.345 10^9 cells per liter Standard Deviation 0.1485	—	—
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Leukocytes	0.02 10^9 cells per liter Standard Deviation 0.679	-0.02 10^9 cells per liter Standard Deviation 1.057	0.45 10^9 cells per liter Standard Deviation 0.212	—	—
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Platelet count	25.0 10^9 cells per liter Standard Deviation 46.35	11.8 10^9 cells per liter Standard Deviation 12.04	13.0 10^9 cells per liter Standard Deviation 2.83	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin	-4.2 Grams per liter Standard Deviation 4.96	-1.8 Grams per liter Standard Deviation 5.98	-1.0 Grams per liter Standard Deviation 5.66	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Hematology Parameter: Hematocrit	-0.0117 Proportion of red blood cells in blood Standard Deviation 0.01684	-0.0073 Proportion of red blood cells in blood Standard Deviation 0.01919	-0.0010 Proportion of red blood cells in blood Standard Deviation 0.01838	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes	-0.10 10^12 cells per liter Standard Deviation 0.190	-0.07 10^12 cells per liter Standard Deviation 0.197	0.00 10^12 cells per liter Standard Deviation 0.141	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume	0.0 Femtoliter Standard Deviation 0.89	-0.3 Femtoliter Standard Deviation 1.03	0.0 Femtoliter Standard Deviation 0.00	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	-0.08 Picograms Standard Deviation 0.286	0.03 Picograms Standard Deviation 0.266	-0.15 Picograms Standard Deviation 0.071	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: reticulocytes/erythrocyte (erythro). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocyte	0.0042 Percentage of reticulocytes in erythro Standard Deviation 0.00449	0.0012 Percentage of reticulocytes in erythro Standard Deviation 0.00172	0.0020 Percentage of reticulocytes in erythro Standard Deviation 0.00000	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=5 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Eosinophils, n=5,6,5,2	-0.066 10^9 cells per liter Standard Deviation 0.2145	-0.047 10^9 cells per liter Standard Deviation 0.1775	0.034 10^9 cells per liter Standard Deviation 0.0404	0.020 10^9 cells per liter Standard Deviation 0.0000	—
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Basophils, n=5,6,5,2	0.010 10^9 cells per liter Standard Deviation 0.0141	0.020 10^9 cells per liter Standard Deviation 0.0237	0.022 10^9 cells per liter Standard Deviation 0.0084	-0.005 10^9 cells per liter Standard Deviation 0.0354	—
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Lymphocytes, n=5,6,5,2	0.006 10^9 cells per liter Standard Deviation 0.4458	-0.062 10^9 cells per liter Standard Deviation 0.4731	0.536 10^9 cells per liter Standard Deviation 0.4766	-0.110 10^9 cells per liter Standard Deviation 0.2687	—
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Monocytes, n=5,6,5,2	-0.020 10^9 cells per liter Standard Deviation 0.0869	0.022 10^9 cells per liter Standard Deviation 0.1705	-0.084 10^9 cells per liter Standard Deviation 0.1436	-0.130 10^9 cells per liter Standard Deviation 0.1131	—
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Neutrophils, n=5,6,5,2	0.424 10^9 cells per liter Standard Deviation 0.6401	1.678 10^9 cells per liter Standard Deviation 2.1754	0.432 10^9 cells per liter Standard Deviation 0.7007	-0.215 10^9 cells per liter Standard Deviation 0.3182	—
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Leukocytes, n=5,6,6,2	0.34 10^9 cells per liter Standard Deviation 0.385	1.62 10^9 cells per liter Standard Deviation 2.244	0.52 10^9 cells per liter Standard Deviation 1.211	-0.45 10^9 cells per liter Standard Deviation 0.071	—
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Platelet count, n=4,6,6,2	1.5 10^9 cells per liter Standard Deviation 45.82	17.5 10^9 cells per liter Standard Deviation 30.26	16.0 10^9 cells per liter Standard Deviation 21.57	4.5 10^9 cells per liter Standard Deviation 0.71	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=5 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin	-8.0 Grams per liter Standard Deviation 5.10	-4.7 Grams per liter Standard Deviation 6.59	-1.7 Grams per liter Standard Deviation 7.31	-8.0 Grams per liter Standard Deviation 1.41	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=5 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Hematology Parameter: Hematocrit	-0.0230 Proportion of red blood cells in blood Standard Deviation 0.01762	-0.0123 Proportion of red blood cells in blood Standard Deviation 0.02096	-0.0058 Proportion of red blood cells in blood Standard Deviation 0.02094	-0.0315 Proportion of red blood cells in blood Standard Deviation 0.01485	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=5 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes	-0.24 10^12 cells per liter Standard Deviation 0.207	-0.17 10^12 cells per liter Standard Deviation 0.216	-0.08 10^12 cells per liter Standard Deviation 0.223	-0.30 10^12 cells per liter Standard Deviation 0.000	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=5 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume	-0.2 Femtoliter Standard Deviation 0.45	0.2 Femtoliter Standard Deviation 0.98	0.2 Femtoliter Standard Deviation 0.98	-2.0 Femtoliter Standard Deviation 2.83	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=5 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	-0.28 Picograms Standard Deviation 0.850	-0.05 Picograms Standard Deviation 0.187	-0.02 Picograms Standard Deviation 0.337	-0.05 Picograms Standard Deviation 0.354	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected to analyze the hematology parameter: reticulocytes/erythro. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=5 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Hematology Parameter: Reticulocytes/Erythro	0.0030 Percentage of reticulocytes in erythro Standard Deviation 0.00235	0.0017 Percentage of reticulocytes in erythro Standard Deviation 0.00258	0.0007 Percentage of reticulocytes in erythro Standard Deviation 0.00350	0.0020 Percentage of reticulocytes in erythro Standard Deviation 0.00283	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol Phosphate, n=6,6,2	0.042 Millimoles per liter Standard Deviation 0.1594	0.058 Millimoles per liter Standard Deviation 0.1772	-0.075 Millimoles per liter Standard Deviation 0.1061	—	—
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol Potassium, n=6,6,2	0.02 Millimoles per liter Standard Deviation 0.240	-0.03 Millimoles per liter Standard Deviation 0.242	-0.10 Millimoles per liter Standard Deviation 0.000	—	—
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol Magnesium, n=6,6,2	0.000 Millimoles per liter Standard Deviation 0.0551	-0.007 Millimoles per liter Standard Deviation 0.0561	-0.020 Millimoles per liter Standard Deviation 0.0283	—	—
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol Sodium, n=6,6,2	0.2 Millimoles per liter Standard Deviation 2.40	-0.8 Millimoles per liter Standard Deviation 1.60	-1.0 Millimoles per liter Standard Deviation 1.41	—	—
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol Urea, n=6,6,2	-0.08 Millimoles per liter Standard Deviation 1.021	-0.08 Millimoles per liter Standard Deviation 0.801	1.00 Millimoles per liter Standard Deviation 0.000	—	—
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol Glucose, n=6,6,2	-0.20 Millimoles per liter Standard Deviation 0.253	0.28 Millimoles per liter Standard Deviation 0.595	0.00 Millimoles per liter Standard Deviation 0.424	—	—
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol Calcium, n=6,6,2	-0.007 Millimoles per liter Standard Deviation 0.1343	-0.027 Millimoles per liter Standard Deviation 0.0468	0.020 Millimoles per liter Standard Deviation 0.0283	—	—
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol Chloride, n=6,6,2	0.0 Millimoles per liter Standard Deviation 2.10	0.8 Millimoles per liter Standard Deviation 3.06	-0.5 Millimoles per liter Standard Deviation 3.54	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) AST	-0.5 International units per liter Standard Deviation 3.94	-2.0 International units per liter Standard Deviation 8.60	4.5 International units per liter Standard Deviation 2.12	—	—
Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) ALT	2.7 International units per liter Standard Deviation 7.79	-1.7 International units per liter Standard Deviation 4.46	9.5 International units per liter Standard Deviation 6.36	—	—
Part 1: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) ALP	10.5 International units per liter Standard Deviation 23.36	-3.5 International units per liter Standard Deviation 4.64	-4.0 International units per liter Standard Deviation 1.41	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin Creatinine	1.77 Micromoles per liter Standard Deviation 5.565	-1.33 Micromoles per liter Standard Deviation 4.291	0.00 Micromoles per liter Standard Deviation 0.000	—	—
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin Bilirubin	-0.3 Micromoles per liter Standard Deviation 3.20	-2.0 Micromoles per liter Standard Deviation 2.53	3.0 Micromoles per liter Standard Deviation 9.90	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Chemistry Parameters: Protein	-1.3 Grams per liter Standard Deviation 4.93	-1.0 Grams per liter Standard Deviation 2.97	1.0 Grams per liter Standard Deviation 2.83	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 6 (Day 11)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. Amylase and lipase results were collected for two participants in GSK3640254 10 mg arm during Part 1 of the study. No data were collected for Placebo and GSK3640254 200 mg arms at Visit 6 (Day 11) due to delays in approval of Protocol Amendment 02 into which testing for amylase and lipase was added.

Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=2 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase Lipase	-2.0 Units per liter Standard Deviation 2.83	—	—	—	—
Part 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase Amylase	0.0 Units per liter Standard Deviation 11.31	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=1 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Glucose, n=6,6,6,1	-0.05 Millimoles per liter Standard Deviation 0.327	0.18 Millimoles per liter Standard Deviation 1.085	-0.03 Millimoles per liter Standard Deviation 0.446	0.50 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Calcium, n=6,6,6,1	-0.057 Millimoles per liter Standard Deviation 0.0638	-0.027 Millimoles per liter Standard Deviation 0.0628	0.030 Millimoles per liter Standard Deviation 0.1002	0.000 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Chloride, n=6,6,6,1	-0.7 Millimoles per liter Standard Deviation 2.25	-0.2 Millimoles per liter Standard Deviation 1.47	-0.7 Millimoles per liter Standard Deviation 2.34	-2.0 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Phosphate, n=6,6,6,1	-0.117 Millimoles per liter Standard Deviation 0.2160	0.067 Millimoles per liter Standard Deviation 0.1211	0.083 Millimoles per liter Standard Deviation 0.1329	0.000 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Potassium, n=6,6,6,1	-0.20 Millimoles per liter Standard Deviation 0.261	0.05 Millimoles per liter Standard Deviation 0.383	0.20 Millimoles per liter Standard Deviation 0.210	-0.10 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Magnesium, n=6,6,6,1	0.007 Millimoles per liter Standard Deviation 0.0484	0.007 Millimoles per liter Standard Deviation 0.0413	0.027 Millimoles per liter Standard Deviation 0.0501	0.000 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Sodium, n=6,6,6,1	-0.8 Millimoles per liter Standard Deviation 2.23	-0.3 Millimoles per liter Standard Deviation 1.37	-0.2 Millimoles per liter Standard Deviation 1.72	-4.0 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Urea, n=6,6,6,1	-0.42 Millimoles per liter Standard Deviation 0.861	-0.25 Millimoles per liter Standard Deviation 1.037	-0.33 Millimoles per liter Standard Deviation 0.931	-0.50 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=1 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST AST	-5.2 International units per liter Standard Deviation 9.37	0.3 International units per liter Standard Deviation 5.79	-4.7 International units per liter Standard Deviation 7.37	4.0 International units per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST ALT	-3.8 International units per liter Standard Deviation 6.62	-1.2 International units per liter Standard Deviation 3.76	-6.2 International units per liter Standard Deviation 8.33	-1.0 International units per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST ALP	-3.2 International units per liter Standard Deviation 3.19	-0.7 International units per liter Standard Deviation 5.35	-1.8 International units per liter Standard Deviation 8.61	-1.0 International units per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=1 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin Bilirubin	-0.3 Micromoles per liter Standard Deviation 2.34	1.3 Micromoles per liter Standard Deviation 6.02	0.3 Micromoles per liter Standard Deviation 1.51	0.0 Micromoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Bilirubin Creatinine	1.35 Micromoles per liter Standard Deviation 3.230	-3.38 Micromoles per liter Standard Deviation 2.230	-0.17 Micromoles per liter Standard Deviation 8.362	-0.90 Micromoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=1 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Chemistry Parameters: Protein	-2.2 Grams per liter Standard Deviation 3.25	-0.8 Grams per liter Standard Deviation 4.07	1.5 Grams per liter Standard Deviation 4.64	-2.0 Grams per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=1 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase Lipase	-1.0 Units per liter Standard Deviation 8.27	-2.2 Units per liter Standard Deviation 6.37	4.5 Units per liter Standard Deviation 8.29	8.0 Units per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase Amylase	-2.3 Units per liter Standard Deviation 8.62	0.8 Units per liter Standard Deviation 9.87	6.7 Units per liter Standard Deviation 7.84	-10.0 Units per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity	0.0002 Ratio Standard Deviation 0.00615	0.0008 Ratio Standard Deviation 0.00232	0.0000 Ratio Standard Deviation 0.00283	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Urinalysis Parameter: Urobilinogen	4.50 Micromoles per liter Standard Deviation 6.971	0.00 Micromoles per liter Standard Deviation 0.000	0.00 Micromoles per liter Standard Deviation 0.000	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH)	0.17 pH Standard Deviation 1.033	-0.33 pH Standard Deviation 0.683	-0.50 pH Standard Deviation 0.000	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity	0.0010 Ratio Standard Deviation 0.00746	-0.0022 Ratio Standard Deviation 0.00794	0.0018 Ratio Standard Deviation 0.00744	-0.0110 Ratio Standard Deviation 0.00424	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Urinalysis Parameter: Urobilinogen	0.00 Micromoles per liter Standard Deviation 0.000	4.50 Micromoles per liter Standard Deviation 6.971	0.00 Micromoles per liter Standard Deviation 0.000	0.00 Micromoles per liter Standard Deviation 0.000	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Urinalysis Parameter: pH	0.17 pH Standard Deviation 0.683	-0.17 pH Standard Deviation 0.683	0.08 pH Standard Deviation 0.492	0.25 pH Standard Deviation 0.354	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP	-2.5 Millimeters of mercury Standard Deviation 8.41	0.5 Millimeters of mercury Standard Deviation 9.65	-1.5 Millimeters of mercury Standard Deviation 3.54	—	—
Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP	-0.3 Millimeters of mercury Standard Deviation 14.50	0.8 Millimeters of mercury Standard Deviation 4.67	0.5 Millimeters of mercury Standard Deviation 0.71	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Respiratory Rate	-1.0 Breaths per minute Standard Deviation 1.79	0.2 Breaths per minute Standard Deviation 2.32	-1.0 Breaths per minute Standard Deviation 1.41	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Pulse Rate	-5.2 Beats per minute Standard Deviation 4.36	5.5 Beats per minute Standard Deviation 10.99	6.0 Beats per minute Standard Deviation 2.83	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population.

SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in SBP and DBP SBP	1.0 Millimeters of mercury Standard Deviation 8.27	-2.2 Millimeters of mercury Standard Deviation 4.45	7.3 Millimeters of mercury Standard Deviation 11.55	1.0 Millimeters of mercury Standard Deviation 2.83	—
Part 2: Change From Baseline in SBP and DBP DBP	-1.8 Millimeters of mercury Standard Deviation 2.40	-1.0 Millimeters of mercury Standard Deviation 6.36	2.3 Millimeters of mercury Standard Deviation 15.72	-0.5 Millimeters of mercury Standard Deviation 7.78	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population.

Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Respiratory Rate	-0.2 Breaths per minute Standard Deviation 1.83	0.2 Breaths per minute Standard Deviation 1.47	-1.0 Breaths per minute Standard Deviation 4.47	0.5 Breaths per minute Standard Deviation 2.12	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population.

Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in Pulse Rate	4.2 Beats per minute Standard Deviation 17.36	2.0 Beats per minute Standard Deviation 11.14	2.8 Beats per minute Standard Deviation 6.40	10.5 Beats per minute Standard Deviation 7.78	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Visit 5 (Days 8 to 10: Pre-dose, 2, 4 and 6 hours)

Population: Safety Population.

Twelve lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcB Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) PR Interval- Days 8 to 10: Pre-dose	-0.4 Milliseconds Standard Deviation 5.32	-7.6 Milliseconds Standard Deviation 5.69	-2.5 Milliseconds Standard Deviation 2.12	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) PR Interval- Days 8 to 10: 2 hours	1.4 Milliseconds Standard Deviation 5.47	-6.3 Milliseconds Standard Deviation 9.71	-11.5 Milliseconds Standard Deviation 0.71	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) PR Interval- Days 8 to 10: 4 hours	-0.1 Milliseconds Standard Deviation 10.00	0.2 Milliseconds Standard Deviation 9.81	-3.5 Milliseconds Standard Deviation 0.71	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) PR Interval- Days 8 to 10: 6 hours	1.4 Milliseconds Standard Deviation 13.22	-5.9 Milliseconds Standard Deviation 3.93	-25.0 Milliseconds Standard Deviation 4.24	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QRS Duration- Days 8 to 10: Pre-dose	-3.1 Milliseconds Standard Deviation 6.65	-3.4 Milliseconds Standard Deviation 9.90	-5.3 Milliseconds Standard Deviation 3.30	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QRS Duration- Days 8 to 10: 2 hours	-2.1 Milliseconds Standard Deviation 6.60	0.4 Milliseconds Standard Deviation 6.27	0.2 Milliseconds Standard Deviation 4.01	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QRS Duration- Days 8 to 10: 4 hours	-3.3 Milliseconds Standard Deviation 3.50	-1.7 Milliseconds Standard Deviation 6.75	-1.3 Milliseconds Standard Deviation 3.77	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QRS Duration- Days 8 to 10: 6 hours	-3.6 Milliseconds Standard Deviation 5.56	-2.9 Milliseconds Standard Deviation 4.55	-2.3 Milliseconds Standard Deviation 13.20	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QT Interval- Days 8 to 10: Pre-dose	0.7 Milliseconds Standard Deviation 8.15	-2.7 Milliseconds Standard Deviation 19.60	-19.7 Milliseconds Standard Deviation 21.21	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QT Interval- Days 8 to 10: 2 hours	-2.4 Milliseconds Standard Deviation 17.61	4.4 Milliseconds Standard Deviation 20.33	-28.7 Milliseconds Standard Deviation 4.24	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QT Interval- Days 8 to 10: 4 hours	8.7 Milliseconds Standard Deviation 18.43	8.9 Milliseconds Standard Deviation 13.72	-25.2 Milliseconds Standard Deviation 19.09	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QT Interval- Days 8 to 10: 6 hours	5.7 Milliseconds Standard Deviation 16.48	5.8 Milliseconds Standard Deviation 14.19	-24.2 Milliseconds Standard Deviation 21.92	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QTcB Interval- Days 8 to 10: Pre-dose	1.65 Milliseconds Standard Deviation 15.813	3.60 Milliseconds Standard Deviation 18.218	-1.38 Milliseconds Standard Deviation 6.435	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QTcB Interval- Days 8 to 10: 2 hours	-10.45 Milliseconds Standard Deviation 22.433	-4.60 Milliseconds Standard Deviation 14.266	-27.38 Milliseconds Standard Deviation 32.315	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QTcB Interval- Days 8 to 10: 4 hours	0.77 Milliseconds Standard Deviation 15.517	-10.37 Milliseconds Standard Deviation 20.176	-30.23 Milliseconds Standard Deviation 51.760	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QTcB Interval- Days 8 to 10: 6 hours	2.65 Milliseconds Standard Deviation 13.391	-9.15 Milliseconds Standard Deviation 15.513	-4.88 Milliseconds Standard Deviation 11.102	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QTcF Interval- Days 8 to 10: Pre-dose	1.2 Milliseconds Standard Deviation 10.75	1.2 Milliseconds Standard Deviation 9.56	-7.7 Milliseconds Standard Deviation 11.31	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QTcF Interval- Days 8 to 10: 2 hours	-7.5 Milliseconds Standard Deviation 19.44	-1.3 Milliseconds Standard Deviation 14.06	-27.7 Milliseconds Standard Deviation 22.63	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QTcF Interval- Days 8 to 10: 4 hours	3.7 Milliseconds Standard Deviation 15.18	-3.7 Milliseconds Standard Deviation 10.84	-28.7 Milliseconds Standard Deviation 41.01	—	—
Part 1: Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB), Corrected QT Interval Using Fridericia's Formula (QTcF) QTcF Interval- Days 8 to 10: 6 hours	4.0 Milliseconds Standard Deviation 12.82	-3.8 Milliseconds Standard Deviation 13.06	-12.2 Milliseconds Standard Deviation 14.85	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Visit 5 (Day 7: Pre-dose, 2, 4 and 6 hours)

Population: Safety Population.

Twelve lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcB Interval and QTcF Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF PR Interval- Day 7: Pre-dose	9.7 Milliseconds Standard Deviation 13.92	-1.1 Milliseconds Standard Deviation 6.89	-7.3 Milliseconds Standard Deviation 9.20	-7.3 Milliseconds Standard Deviation 0.47	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF PR Interval- Day 7: 2 hours	6.1 Milliseconds Standard Deviation 14.20	-2.4 Milliseconds Standard Deviation 7.90	-3.1 Milliseconds Standard Deviation 8.61	6.2 Milliseconds Standard Deviation 2.59	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF PR Interval- Day 7: 4 hours	5.2 Milliseconds Standard Deviation 22.87	1.1 Milliseconds Standard Deviation 8.56	-8.3 Milliseconds Standard Deviation 6.81	4.7 Milliseconds Standard Deviation 5.19	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF PR Interval- Day 7: 6 hours	3.9 Milliseconds Standard Deviation 16.80	-2.3 Milliseconds Standard Deviation 6.24	-2.1 Milliseconds Standard Deviation 5.82	-7.8 Milliseconds Standard Deviation 9.66	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QRS Duration- Day 7: Pre-dose	3.9 Milliseconds Standard Deviation 5.11	3.2 Milliseconds Standard Deviation 7.81	-0.4 Milliseconds Standard Deviation 6.87	2.3 Milliseconds Standard Deviation 7.07	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QRS Duration- Day 7: 2 hours	2.4 Milliseconds Standard Deviation 4.18	0.7 Milliseconds Standard Deviation 4.89	-0.1 Milliseconds Standard Deviation 8.45	4.3 Milliseconds Standard Deviation 1.41	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QRS Duration- Day 7: 4 hours	1.7 Milliseconds Standard Deviation 4.06	0.1 Milliseconds Standard Deviation 4.41	-3.1 Milliseconds Standard Deviation 6.25	3.8 Milliseconds Standard Deviation 3.54	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QRS Duration- Day 7: 6 hours	0.5 Milliseconds Standard Deviation 11.78	-0.1 Milliseconds Standard Deviation 3.04	-0.8 Milliseconds Standard Deviation 3.70	2.8 Milliseconds Standard Deviation 6.36	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QT Interval- Day 7: Pre-dose	-7.4 Milliseconds Standard Deviation 33.78	-1.6 Milliseconds Standard Deviation 13.03	5.0 Milliseconds Standard Deviation 20.49	3.2 Milliseconds Standard Deviation 2.59	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QT Interval- Day 7: 2 hours	-24.4 Milliseconds Standard Deviation 33.17	-4.4 Milliseconds Standard Deviation 8.90	1.8 Milliseconds Standard Deviation 12.60	-0.3 Milliseconds Standard Deviation 6.13	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QT Interval- Day 7: 4 hours	-12.8 Milliseconds Standard Deviation 25.96	4.2 Milliseconds Standard Deviation 12.84	-1.7 Milliseconds Standard Deviation 13.65	11.2 Milliseconds Standard Deviation 19.56	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QT Interval- Day 7: 6 hours	-21.4 Milliseconds Standard Deviation 36.18	5.9 Milliseconds Standard Deviation 12.19	0.7 Milliseconds Standard Deviation 12.92	2.7 Milliseconds Standard Deviation 7.54	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QTcB Interval- Day 7: Pre-dose	-4.16 Milliseconds Standard Deviation 14.780	0.34 Milliseconds Standard Deviation 11.468	3.45 Milliseconds Standard Deviation 6.785	-7.08 Milliseconds Standard Deviation 2.569	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QTcB Interval- Day 7: 2 hours	2.90 Milliseconds Standard Deviation 19.936	0.09 Milliseconds Standard Deviation 14.494	-4.88 Milliseconds Standard Deviation 17.444	-18.23 Milliseconds Standard Deviation 2.923	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QTcB Interval- Day 7: 4 hours	-6.96 Milliseconds Standard Deviation 23.150	-0.56 Milliseconds Standard Deviation 13.559	1.30 Milliseconds Standard Deviation 14.341	-23.83 Milliseconds Standard Deviation 2.781	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QTcB Interval- Day 7: 6 hours	-3.26 Milliseconds Standard Deviation 16.691	4.17 Milliseconds Standard Deviation 12.302	-1.68 Milliseconds Standard Deviation 10.181	-9.83 Milliseconds Standard Deviation 17.489	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QTcF Interval- Day 7: Pre-dose	-5.9 Milliseconds Standard Deviation 18.89	-0.5 Milliseconds Standard Deviation 4.12	4.1 Milliseconds Standard Deviation 9.23	-3.3 Milliseconds Standard Deviation 0.94	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QTcF Interval- Day 7: 2 hours	-7.2 Milliseconds Standard Deviation 22.91	-1.3 Milliseconds Standard Deviation 8.73	-2.3 Milliseconds Standard Deviation 12.87	-12.3 Milliseconds Standard Deviation 0.47	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QTcF Interval- Day 7: 4 hours	-9.4 Milliseconds Standard Deviation 21.24	1.2 Milliseconds Standard Deviation 8.15	0.6 Milliseconds Standard Deviation 9.00	-12.3 Milliseconds Standard Deviation 4.71	—
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcB, QTcF QTcF Interval- Day 7: 6 hours	-9.5 Milliseconds Standard Deviation 19.08	4.5 Milliseconds Standard Deviation 5.69	-0.8 Milliseconds Standard Deviation 7.79	-5.8 Milliseconds Standard Deviation 8.72	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Basophils, n=6,5,2	0.052 10^9 cells per liter Standard Deviation 0.0279	0.056 10^9 cells per liter Standard Deviation 0.0321	0.030 10^9 cells per liter Standard Deviation 0.0000	—	—
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Days 8 to 10: Basophils, n=6,6,2	0.057 10^9 cells per liter Standard Deviation 0.0266	0.037 10^9 cells per liter Standard Deviation 0.0186	0.045 10^9 cells per liter Standard Deviation 0.0212	—	—
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Eosinophils, n=6,5,2	0.212 10^9 cells per liter Standard Deviation 0.1783	0.150 10^9 cells per liter Standard Deviation 0.0616	0.105 10^9 cells per liter Standard Deviation 0.0212	—	—
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Days 8 to 10: Eosinophils, n=6,6,2	0.188 10^9 cells per liter Standard Deviation 0.0873	0.202 10^9 cells per liter Standard Deviation 0.1003	0.080 10^9 cells per liter Standard Deviation 0.0424	—	—
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Lymphocytes, n=6,5,2	2.303 10^9 cells per liter Standard Deviation 0.5431	1.810 10^9 cells per liter Standard Deviation 0.4341	2.010 10^9 cells per liter Standard Deviation 0.0707	—	—
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Days 8 to 10: Lymphocytes, n=6,6,2	2.277 10^9 cells per liter Standard Deviation 0.4484	2.217 10^9 cells per liter Standard Deviation 0.6693	2.080 10^9 cells per liter Standard Deviation 0.1273	—	—
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Monocytes, n=6,5,2	0.552 10^9 cells per liter Standard Deviation 0.2033	0.530 10^9 cells per liter Standard Deviation 0.1814	0.460 10^9 cells per liter Standard Deviation 0.0000	—	—
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Days 8 to 10: Monocytes, n=6,6,2	0.652 10^9 cells per liter Standard Deviation 0.1907	0.508 10^9 cells per liter Standard Deviation 0.2088	0.515 10^9 cells per liter Standard Deviation 0.0212	—	—
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Neutrophils, n=6,5,2	2.935 10^9 cells per liter Standard Deviation 0.4803	3.094 10^9 cells per liter Standard Deviation 0.7279	1.840 10^9 cells per liter Standard Deviation 0.4101	—	—
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Days 8 to 10: Neutrophils, n=6,6,2	2.890 10^9 cells per liter Standard Deviation 0.6049	2.635 10^9 cells per liter Standard Deviation 0.4068	2.185 10^9 cells per liter Standard Deviation 0.2616	—	—
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Leukocytes, n=6,5,2	6.05 10^9 cells per liter Standard Deviation 1.071	5.64 10^9 cells per liter Standard Deviation 1.172	4.45 10^9 cells per liter Standard Deviation 0.495	—	—
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Days 8 to 10: Leukocytes, n=6,6,2	6.07 10^9 cells per liter Standard Deviation 0.929	5.60 10^9 cells per liter Standard Deviation 1.158	4.90 10^9 cells per liter Standard Deviation 0.283	—	—
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Platelet count, n=6,5,2	208.8 10^9 cells per liter Standard Deviation 38.48	202.0 10^9 cells per liter Standard Deviation 39.26	195.5 10^9 cells per liter Standard Deviation 12.02	—	—
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Days 8 to 10: Platelet count, n=6,6,2	233.8 10^9 cells per liter Standard Deviation 70.34	205.0 10^9 cells per liter Standard Deviation 43.38	208.5 10^9 cells per liter Standard Deviation 14.85	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Hematology Parameter: Hemoglobin Baseline (Day 1): n=6,5,2	144.2 Grams per liter Standard Deviation 11.55	135.4 Grams per liter Standard Deviation 9.42	148.0 Grams per liter Standard Deviation 4.24	—	—
Part 1: Absolute Values for Hematology Parameter: Hemoglobin Days 8 to 10: n=6,6,2	140.0 Grams per liter Standard Deviation 12.18	138.7 Grams per liter Standard Deviation 12.72	147.0 Grams per liter Standard Deviation 9.90	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Hematology Parameter: Hematocrit Baseline (Day 1): n=6,5,2	0.4338 Proportion of red blood cells in blood Standard Deviation 0.02709	0.4112 Proportion of red blood cells in blood Standard Deviation 0.02523	0.4395 Proportion of red blood cells in blood Standard Deviation 0.01344	—	—
Part 1: Absolute Values for Hematology Parameter: Hematocrit Days 8 to 10: n=6,6,2	0.4222 Proportion of red blood cells in blood Standard Deviation 0.03456	0.4158 Proportion of red blood cells in blood Standard Deviation 0.02827	0.4385 Proportion of red blood cells in blood Standard Deviation 0.03182	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Baseline (Day 1): n=6,5,2	4.90 10^12 cells per liter Standard Deviation 0.228	4.58 10^12 cells per liter Standard Deviation 0.259	4.90 10^12 cells per liter Standard Deviation 0.283	—	—
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Days 8 to 10: n=6,6,2	4.80 10^12 cells per liter Standard Deviation 0.290	4.63 10^12 cells per liter Standard Deviation 0.327	4.90 10^12 cells per liter Standard Deviation 0.424	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume Baseline (Day 1): n=6,5,2	88.5 Femtoliter Standard Deviation 3.67	90.2 Femtoliter Standard Deviation 3.49	90.0 Femtoliter Standard Deviation 1.41	—	—
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume Days 8 to 10: n=6,6,2	88.5 Femtoliter Standard Deviation 4.09	90.0 Femtoliter Standard Deviation 2.28	90.0 Femtoliter Standard Deviation 1.41	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Baseline (Day 1): n=6,5,2	29.38 Picograms Standard Deviation 1.780	29.64 Picograms Standard Deviation 0.879	30.25 Picograms Standard Deviation 0.636	—	—
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Days 8 to 10: n=6,6,2	29.30 Picograms Standard Deviation 1.747	29.97 Picograms Standard Deviation 0.942	30.10 Picograms Standard Deviation 0.707	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the hematology parameter: reticulocytes/erythro. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Hematology Parameter: Reticulocytes/Erythro Baseline (Day 1): n=6,5,2	0.0137 Percentage of reticulocytes in erythro Standard Deviation 0.00726	0.0078 Percentage of reticulocytes in erythro Standard Deviation 0.00349	0.0110 Percentage of reticulocytes in erythro Standard Deviation 0.00424	—	—
Part 1: Absolute Values for Hematology Parameter: Reticulocytes/Erythro Days 8 to 10: n=6,6,2	0.0178 Percentage of reticulocytes in erythro Standard Deviation 0.01139	0.0088 Percentage of reticulocytes in erythro Standard Deviation 0.00264	0.0130 Percentage of reticulocytes in erythro Standard Deviation 0.00424	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Day 7: Monocytes, n=5,6,5,2	0.530 10^9 cells per liter Standard Deviation 0.2210	0.498 10^9 cells per liter Standard Deviation 0.2647	0.414 10^9 cells per liter Standard Deviation 0.1467	0.305 10^9 cells per liter Standard Deviation 0.0071	—
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Neutrophils, n=6,6,5,2	2.512 10^9 cells per liter Standard Deviation 1.2631	2.442 10^9 cells per liter Standard Deviation 1.1951	3.060 10^9 cells per liter Standard Deviation 0.5711	2.280 10^9 cells per liter Standard Deviation 1.0465	—
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Day 7: Platelet count, n=4,6,6,2	292.0 10^9 cells per liter Standard Deviation 77.06	254.2 10^9 cells per liter Standard Deviation 37.39	249.0 10^9 cells per liter Standard Deviation 38.72	201.5 10^9 cells per liter Standard Deviation 60.10	—
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Basophils, n=6,6,5,2	0.042 10^9 cells per liter Standard Deviation 0.0232	0.042 10^9 cells per liter Standard Deviation 0.0117	0.030 10^9 cells per liter Standard Deviation 0.0200	0.040 10^9 cells per liter Standard Deviation 0.0283	—
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Day 7: Basophils, n=5,6,5,2	0.050 10^9 cells per liter Standard Deviation 0.0274	0.062 10^9 cells per liter Standard Deviation 0.0223	0.054 10^9 cells per liter Standard Deviation 0.0251	0.035 10^9 cells per liter Standard Deviation 0.0071	—
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Eosinophils, n=6,6,5,2	0.402 10^9 cells per liter Standard Deviation 0.3307	0.290 10^9 cells per liter Standard Deviation 0.2628	0.320 10^9 cells per liter Standard Deviation 0.2542	0.055 10^9 cells per liter Standard Deviation 0.0354	—
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Day 7: Eosinophils, n=5,6,5,2	0.316 10^9 cells per liter Standard Deviation 0.1780	0.243 10^9 cells per liter Standard Deviation 0.1546	0.210 10^9 cells per liter Standard Deviation 0.1239	0.075 10^9 cells per liter Standard Deviation 0.0354	—
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Lymphocytes, n=6,6,5,2	1.990 10^9 cells per liter Standard Deviation 0.3013	2.047 10^9 cells per liter Standard Deviation 0.6167	2.236 10^9 cells per liter Standard Deviation 0.3010	1.865 10^9 cells per liter Standard Deviation 0.3606	—
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Day 7: Lymphocytes, n=5,6,5,2	1.960 10^9 cells per liter Standard Deviation 0.3450	1.985 10^9 cells per liter Standard Deviation 0.2983	2.694 10^9 cells per liter Standard Deviation 0.7060	1.755 10^9 cells per liter Standard Deviation 0.0919	—
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Monocytes, n=6,6,5,2	0.560 10^9 cells per liter Standard Deviation 0.2082	0.477 10^9 cells per liter Standard Deviation 0.1442	0.534 10^9 cells per liter Standard Deviation 0.1459	0.435 10^9 cells per liter Standard Deviation 0.1061	—
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Day 7: Neutrophils, n=5,6,5,2	2.826 10^9 cells per liter Standard Deviation 1.1821	4.120 10^9 cells per liter Standard Deviation 2.9025	3.344 10^9 cells per liter Standard Deviation 0.6322	2.065 10^9 cells per liter Standard Deviation 1.3647	—
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Leukocytes, n=6,6,5,2	5.50 10^9 cells per liter Standard Deviation 1.633	5.28 10^9 cells per liter Standard Deviation 1.947	6.20 10^9 cells per liter Standard Deviation 0.938	4.65 10^9 cells per liter Standard Deviation 1.485	—
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Day 7: Leukocytes, n=5,6,6,2	5.66 10^9 cells per liter Standard Deviation 1.527	6.90 10^9 cells per liter Standard Deviation 3.310	6.55 10^9 cells per liter Standard Deviation 0.973	4.20 10^9 cells per liter Standard Deviation 1.414	—
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes, Platelet Count Baseline (Day 1): Platelet count, n=5,6,5,2	276.6 10^9 cells per liter Standard Deviation 54.29	236.7 10^9 cells per liter Standard Deviation 41.87	232.2 10^9 cells per liter Standard Deviation 40.12	197.0 10^9 cells per liter Standard Deviation 59.40	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Hematology Parameter: Hemoglobin Baseline (Day 1): n=6,6,5,2	136.3 Grams per liter Standard Deviation 16.34	149.2 Grams per liter Standard Deviation 13.44	141.2 Grams per liter Standard Deviation 7.98	147.0 Grams per liter Standard Deviation 7.07	—
Part 2: Absolute Values for Hematology Parameter: Hemoglobin Day 7: n=5,6,6,2	129.4 Grams per liter Standard Deviation 19.55	144.5 Grams per liter Standard Deviation 7.87	135.8 Grams per liter Standard Deviation 11.02	139.0 Grams per liter Standard Deviation 8.49	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Hematology Parameter: Hematocrit Baseline (Day 1): n=6,6,5,2	0.4037 Proportion of red blood cells in blood Standard Deviation 0.04646	0.4505 Proportion of red blood cells in blood Standard Deviation 0.02992	0.4222 Proportion of red blood cells in blood Standard Deviation 0.01879	0.4330 Proportion of red blood cells in blood Standard Deviation 0.01838	—
Part 2: Absolute Values for Hematology Parameter: Hematocrit Day 7: n=5,6,6,2	0.3826 Proportion of red blood cells in blood Standard Deviation 0.05125	0.4382 Proportion of red blood cells in blood Standard Deviation 0.01579	0.4062 Proportion of red blood cells in blood Standard Deviation 0.03107	0.4015 Proportion of red blood cells in blood Standard Deviation 0.03323	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Baseline (Day 1): n=6,6,5,2	4.53 10^12 cells per liter Standard Deviation 0.476	5.17 10^12 cells per liter Standard Deviation 0.450	4.74 10^12 cells per liter Standard Deviation 0.230	4.80 10^12 cells per liter Standard Deviation 0.000	—
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Day 7: n=5,6,6,2	4.26 10^12 cells per liter Standard Deviation 0.503	5.00 10^12 cells per liter Standard Deviation 0.518	4.52 10^12 cells per liter Standard Deviation 0.431	4.50 10^12 cells per liter Standard Deviation 0.000	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume Day 7: n=5,6,6,2	89.6 Femtoliter Standard Deviation 3.44	88.0 Femtoliter Standard Deviation 8.53	90.0 Femtoliter Standard Deviation 2.97	89.0 Femtoliter Standard Deviation 7.07	—
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume Baseline (Day 1): n=6,6,5,2	88.8 Femtoliter Standard Deviation 3.76	87.8 Femtoliter Standard Deviation 8.59	89.2 Femtoliter Standard Deviation 1.64	91.0 Femtoliter Standard Deviation 4.24	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Baseline (Day 1): n=6,6,5,2	30.07 Picograms Standard Deviation 1.870	29.15 Picograms Standard Deviation 3.531	29.80 Picograms Standard Deviation 0.925	30.95 Picograms Standard Deviation 1.485	—
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Day 7: n=5,6,6,2	30.22 Picograms Standard Deviation 2.017	29.10 Picograms Standard Deviation 3.553	29.97 Picograms Standard Deviation 0.898	30.90 Picograms Standard Deviation 1.838	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the hematology parameter: reticulocytes/erythro. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro Baseline (Day 1): n=6,6,5,2	0.0102 Percentage of reticulocytes in erythro Standard Deviation 0.00223	0.0082 Percentage of reticulocytes in erythro Standard Deviation 0.00147	0.0108 Percentage of reticulocytes in erythro Standard Deviation 0.00492	0.0070 Percentage of reticulocytes in erythro Standard Deviation 0.00141	—
Part 2: Absolute Values for Hematology Parameter: Reticulocytes/Erythro Day 7: n=5,6,6,2	0.0124 Percentage of reticulocytes in erythro Standard Deviation 0.00297	0.0098 Percentage of reticulocytes in erythro Standard Deviation 0.00160	0.0107 Percentage of reticulocytes in erythro Standard Deviation 0.00344	0.0090 Percentage of reticulocytes in erythro Standard Deviation 0.00141	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Cholesterol, n=6,6,2	4.700 Millimoles per liter Standard Deviation 1.2345	4.058 Millimoles per liter Standard Deviation 0.9641	4.350 Millimoles per liter Standard Deviation 0.6364	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Triglycerides, n=6,6,2	1.070 Millimoles per liter Standard Deviation 0.4527	1.150 Millimoles per liter Standard Deviation 0.5114	0.950 Millimoles per liter Standard Deviation 0.4101	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Days 8 to 10: Calcium, n=6,6,2	2.293 Millimoles per liter Standard Deviation 0.0816	2.287 Millimoles per liter Standard Deviation 0.0561	2.350 Millimoles per liter Standard Deviation 0.0424	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Chloride, n=6,6,2	104.2 Millimoles per liter Standard Deviation 0.41	105.8 Millimoles per liter Standard Deviation 2.48	105.0 Millimoles per liter Standard Deviation 2.83	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Days 8 to 10: Chloride, n=6,6,2	104.2 Millimoles per liter Standard Deviation 1.72	106.7 Millimoles per liter Standard Deviation 1.21	104.5 Millimoles per liter Standard Deviation 0.71	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Phosphate, n=6,6,2	1.117 Millimoles per liter Standard Deviation 0.1835	1.083 Millimoles per liter Standard Deviation 0.1889	1.200 Millimoles per liter Standard Deviation 0.0707	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Days 8 to 10: Potassium, n=6,6,2	4.12 Millimoles per liter Standard Deviation 0.349	4.27 Millimoles per liter Standard Deviation 0.216	4.05 Millimoles per liter Standard Deviation 0.212	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Magnesium, n=6,6,2	0.847 Millimoles per liter Standard Deviation 0.0393	0.853 Millimoles per liter Standard Deviation 0.0450	0.880 Millimoles per liter Standard Deviation 0.0283	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Days 8 to 10: Magnesium, n=6,6,2	0.847 Millimoles per liter Standard Deviation 0.0561	0.847 Millimoles per liter Standard Deviation 0.0393	0.860 Millimoles per liter Standard Deviation 0.0000	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Sodium, n=6,6,2	138.3 Millimoles per liter Standard Deviation 2.25	139.8 Millimoles per liter Standard Deviation 0.75	139.0 Millimoles per liter Standard Deviation 0.00	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Days 8 to 10: Sodium, n=6,6,2	138.5 Millimoles per liter Standard Deviation 2.17	139.0 Millimoles per liter Standard Deviation 0.89	138.0 Millimoles per liter Standard Deviation 1.41	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Urea, n=6,6,2	5.33 Millimoles per liter Standard Deviation 0.516	5.83 Millimoles per liter Standard Deviation 1.169	5.00 Millimoles per liter Standard Deviation 0.707	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Days 8 to 10: Urea, n=6,6,2	5.25 Millimoles per liter Standard Deviation 1.037	5.75 Millimoles per liter Standard Deviation 0.524	6.00 Millimoles per liter Standard Deviation 0.707	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): HDL cholesterol, n=6,6,2	1.192 Millimoles per liter Standard Deviation 0.1960	1.025 Millimoles per liter Standard Deviation 0.0612	1.075 Millimoles per liter Standard Deviation 0.0354	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): LDL cholesterol, n=6,6,2	3.017 Millimoles per liter Standard Deviation 1.0452	2.507 Millimoles per liter Standard Deviation 0.7842	2.840 Millimoles per liter Standard Deviation 0.4808	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Glucose, n=6,6,2	5.28 Millimoles per liter Standard Deviation 0.556	4.88 Millimoles per liter Standard Deviation 0.546	5.40 Millimoles per liter Standard Deviation 0.141	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Days 8 to 10: Glucose, n=6,6,2	5.08 Millimoles per liter Standard Deviation 0.618	5.17 Millimoles per liter Standard Deviation 0.528	5.40 Millimoles per liter Standard Deviation 0.283	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Calcium, n=6,6,2	2.300 Millimoles per liter Standard Deviation 0.1073	2.313 Millimoles per liter Standard Deviation 0.0961	2.330 Millimoles per liter Standard Deviation 0.0141	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Days 8 to 10: Phosphate, n=6,6,2	1.158 Millimoles per liter Standard Deviation 0.1882	1.142 Millimoles per liter Standard Deviation 0.2245	1.125 Millimoles per liter Standard Deviation 0.1768	—	—
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Potassium, n=6,6,2	4.10 Millimoles per liter Standard Deviation 0.210	4.30 Millimoles per liter Standard Deviation 0.276	4.15 Millimoles per liter Standard Deviation 0.212	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST Baseline (Day 1): ALT	31.3 International units per liter Standard Deviation 15.67	19.7 International units per liter Standard Deviation 15.82	20.0 International units per liter Standard Deviation 8.49	—	—
Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST Days 8 to 10: ALT	34.0 International units per liter Standard Deviation 21.58	18.0 International units per liter Standard Deviation 11.85	29.5 International units per liter Standard Deviation 14.85	—	—
Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST Baseline (Day 1): ALP	62.0 International units per liter Standard Deviation 10.55	62.3 International units per liter Standard Deviation 19.13	63.0 International units per liter Standard Deviation 2.83	—	—
Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST Days 8 to 10: ALP	72.5 International units per liter Standard Deviation 27.68	58.8 International units per liter Standard Deviation 16.46	59.0 International units per liter Standard Deviation 1.41	—	—
Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST Baseline (Day 1): AST	26.7 International units per liter Standard Deviation 9.42	23.3 International units per liter Standard Deviation 10.76	20.0 International units per liter Standard Deviation 8.49	—	—
Part 1: Absolute Values for Chemistry Parameters: ALT, ALP, AST Days 8 to 10: AST	26.2 International units per liter Standard Deviation 11.27	21.3 International units per liter Standard Deviation 4.63	24.5 International units per liter Standard Deviation 10.61	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin Baseline (Day 1): Creatinine	82.05 Micromoles per liter Standard Deviation 11.319	81.35 Micromoles per liter Standard Deviation 3.861	88.40 Micromoles per liter Standard Deviation 3.818	—	—
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin Days 8 to 10: Creatinine	83.82 Micromoles per liter Standard Deviation 13.674	80.02 Micromoles per liter Standard Deviation 6.239	88.40 Micromoles per liter Standard Deviation 3.818	—	—
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin Baseline (Day 1): Bilirubin	11.7 Micromoles per liter Standard Deviation 6.38	8.0 Micromoles per liter Standard Deviation 2.83	15.0 Micromoles per liter Standard Deviation 1.41	—	—
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin Days 8 to 10: Bilirubin	11.3 Micromoles per liter Standard Deviation 3.50	6.0 Micromoles per liter Standard Deviation 1.79	18.0 Micromoles per liter Standard Deviation 8.49	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Blood samples were collected at Baseline and one sample between Days 8 to 10 to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Chemistry Parameters: Protein Baseline (Day 1)	72.2 Grams per liter Standard Deviation 3.06	70.3 Grams per liter Standard Deviation 2.34	69.0 Grams per liter Standard Deviation 1.41	—	—
Part 1: Absolute Values for Chemistry Parameters: Protein Days 8 to 10	70.8 Grams per liter Standard Deviation 3.60	69.3 Grams per liter Standard Deviation 5.05	70.0 Grams per liter Standard Deviation 1.41	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 6 (Day 11)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. Amylase and lipase results were collected for two participants in GSK3640254 10 mg arm during Part 1 of the study. No data were collected for Placebo and GSK3640254 200 mg arms at Visit 6 (Day 11) due to delays in approval of Protocol Amendment 02 into which testing for amylase and lipase was added.

Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=2 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Chemistry Parameters: Amylase, Lipase Baseline (Day 1): Amylase	57.0 Units per liter Standard Deviation 11.31	—	—	—	—
Part 1: Absolute Values for Chemistry Parameters: Amylase, Lipase Day 11: Amylase	57.0 Units per liter Standard Deviation 0.00	—	—	—	—
Part 1: Absolute Values for Chemistry Parameters: Amylase, Lipase Baseline (Day 1): Lipase	28.5 Units per liter Standard Deviation 4.95	—	—	—	—
Part 1: Absolute Values for Chemistry Parameters: Amylase, Lipase Day 11: Lipase	26.5 Units per liter Standard Deviation 7.78	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, calcium, chloride, phosphate, potassium, magnesium, sodium, urea, HDL cholesterol and LDL cholesterol. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Glucose, n=6,6,6,2	4.68 Millimoles per liter Standard Deviation 0.306	4.72 Millimoles per liter Standard Deviation 0.928	4.80 Millimoles per liter Standard Deviation 0.456	4.90 Millimoles per liter Standard Deviation 0.849	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Day 7: Glucose, n=6,6,6,1	4.63 Millimoles per liter Standard Deviation 0.408	4.90 Millimoles per liter Standard Deviation 0.190	4.77 Millimoles per liter Standard Deviation 0.320	4.80 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Cholesterol, n=6,6,6,2	4.233 Millimoles per liter Standard Deviation 0.6758	4.375 Millimoles per liter Standard Deviation 1.1626	4.150 Millimoles per liter Standard Deviation 0.8573	3.400 Millimoles per liter Standard Deviation 0.3536	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Triglycerides, n=6,6,6,2	1.183 Millimoles per liter Standard Deviation 0.1924	1.447 Millimoles per liter Standard Deviation 0.6008	1.120 Millimoles per liter Standard Deviation 0.4879	0.540 Millimoles per liter Standard Deviation 0.1980	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Chloride, n=6,6,6,2	103.0 Millimoles per liter Standard Deviation 1.67	102.2 Millimoles per liter Standard Deviation 2.64	103.7 Millimoles per liter Standard Deviation 2.34	105.5 Millimoles per liter Standard Deviation 0.71	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Day 7: Chloride, n=6,6,6,1	102.3 Millimoles per liter Standard Deviation 1.51	102.0 Millimoles per liter Standard Deviation 1.79	103.0 Millimoles per liter Standard Deviation 1.10	104.0 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Phosphate, n=6,6,6,2	1.317 Millimoles per liter Standard Deviation 0.1693	1.108 Millimoles per liter Standard Deviation 0.1281	1.083 Millimoles per liter Standard Deviation 0.1211	0.950 Millimoles per liter Standard Deviation 0.2828	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Day 7: Phosphate, n=6,6,6,1	1.200 Millimoles per liter Standard Deviation 0.1265	1.175 Millimoles per liter Standard Deviation 0.1969	1.167 Millimoles per liter Standard Deviation 0.1329	0.750 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Potassium, n=6,6,6,2	4.07 Millimoles per liter Standard Deviation 0.476	3.98 Millimoles per liter Standard Deviation 0.325	3.95 Millimoles per liter Standard Deviation 0.164	4.10 Millimoles per liter Standard Deviation 0.424	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Day 7: Potassium, n=6,6,6,1	3.87 Millimoles per liter Standard Deviation 0.273	4.03 Millimoles per liter Standard Deviation 0.242	4.15 Millimoles per liter Standard Deviation 0.122	3.70 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Magnesium, n=6,6,6,2	0.790 Millimoles per liter Standard Deviation 0.0395	0.830 Millimoles per liter Standard Deviation 0.0518	0.803 Millimoles per liter Standard Deviation 0.0320	0.810 Millimoles per liter Standard Deviation 0.0707	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Sodium, n=6,6,6,2	137.7 Millimoles per liter Standard Deviation 1.63	138.5 Millimoles per liter Standard Deviation 2.43	137.8 Millimoles per liter Standard Deviation 3.06	140.5 Millimoles per liter Standard Deviation 2.12	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): HDL cholesterol, n=6,6,6,2	1.242 Millimoles per liter Standard Deviation 0.3277	1.133 Millimoles per liter Standard Deviation 0.3312	1.200 Millimoles per liter Standard Deviation 0.3194	1.250 Millimoles per liter Standard Deviation 0.0707	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): LDL cholesterol, n=6,6,6,2	2.448 Millimoles per liter Standard Deviation 0.6649	2.578 Millimoles per liter Standard Deviation 0.8267	2.437 Millimoles per liter Standard Deviation 0.6955	1.905 Millimoles per liter Standard Deviation 0.3748	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Day 7: Magnesium, n=6,6,6,1	0.797 Millimoles per liter Standard Deviation 0.0731	0.837 Millimoles per liter Standard Deviation 0.0427	0.830 Millimoles per liter Standard Deviation 0.0654	0.760 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Day 7: Sodium, n=6,6,6,1	136.8 Millimoles per liter Standard Deviation 3.54	138.2 Millimoles per liter Standard Deviation 1.94	137.7 Millimoles per liter Standard Deviation 1.97	138.0 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Urea, n=6,6,6,2	4.50 Millimoles per liter Standard Deviation 1.517	4.25 Millimoles per liter Standard Deviation 1.508	5.92 Millimoles per liter Standard Deviation 1.068	6.25 Millimoles per liter Standard Deviation 2.475	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Day 7: Urea, n=6,6,6,1	4.08 Millimoles per liter Standard Deviation 0.970	4.00 Millimoles per liter Standard Deviation 0.632	5.58 Millimoles per liter Standard Deviation 0.492	4.00 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Baseline (Day 1): Calcium, n=6,6,6,2	2.330 Millimoles per liter Standard Deviation 0.0629	2.320 Millimoles per liter Standard Deviation 0.0980	2.290 Millimoles per liter Standard Deviation 0.0701	2.280 Millimoles per liter Standard Deviation 0.0849	—
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Calcium, Chloride, Phosphate, Potassium, Magnesium, Sodium, Urea, HDL Cholesterol, LDL Cholesterol Day 7: Calcium, n=6,6,6,1	2.273 Millimoles per liter Standard Deviation 0.0628	2.293 Millimoles per liter Standard Deviation 0.0766	2.320 Millimoles per liter Standard Deviation 0.0780	2.220 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST Day 7: AST, n=6,6,6,1	21.7 International units per liter Standard Deviation 6.74	18.8 International units per liter Standard Deviation 3.31	22.0 International units per liter Standard Deviation 3.74	26.0 International units per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST Baseline (Day 1): ALT, n=6,6,6,2	18.3 International units per liter Standard Deviation 14.07	17.8 International units per liter Standard Deviation 7.63	33.2 International units per liter Standard Deviation 23.07	34.5 International units per liter Standard Deviation 6.36	—
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST Day 7: ALT, n=6,6,6,1	14.5 International units per liter Standard Deviation 7.66	16.7 International units per liter Standard Deviation 5.24	27.0 International units per liter Standard Deviation 18.00	29.0 International units per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST Baseline (Day 1): ALP, n=6,6,6,2	63.3 International units per liter Standard Deviation 15.08	63.7 International units per liter Standard Deviation 4.68	60.8 International units per liter Standard Deviation 9.00	43.0 International units per liter Standard Deviation 18.38	—
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST Day 7: ALP, n=6,6,6,1	60.2 International units per liter Standard Deviation 16.53	63.0 International units per liter Standard Deviation 5.25	59.0 International units per liter Standard Deviation 5.18	55.0 International units per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST Baseline (Day 1): AST, n=6,6,6,2	26.8 International units per liter Standard Deviation 15.39	18.5 International units per liter Standard Deviation 6.60	26.7 International units per liter Standard Deviation 8.14	50.0 International units per liter Standard Deviation 39.60	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the chemistry parameters: creatinine and bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin Baseline (Day 1): Creatinine, n=6,6,6,2	71.30 Micromoles per liter Standard Deviation 12.207	73.67 Micromoles per liter Standard Deviation 7.120	73.52 Micromoles per liter Standard Deviation 12.761	86.65 Micromoles per liter Standard Deviation 13.789	—
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin Day 7: Creatinine, n=6,6,6,1	72.65 Micromoles per liter Standard Deviation 14.109	70.28 Micromoles per liter Standard Deviation 8.269	73.35 Micromoles per liter Standard Deviation 8.195	76.00 Micromoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin Baseline (Day 1): Bilirubin, n=6,6,6,2	10.0 Micromoles per liter Standard Deviation 5.66	9.3 Micromoles per liter Standard Deviation 1.03	7.7 Micromoles per liter Standard Deviation 3.44	11.0 Micromoles per liter Standard Deviation 7.07	—
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Bilirubin Day 7: Bilirubin, n=6,6,6,1	9.7 Micromoles per liter Standard Deviation 4.97	10.7 Micromoles per liter Standard Deviation 5.47	8.0 Micromoles per liter Standard Deviation 2.83	6.0 Micromoles per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the chemistry parameter: protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Chemistry Parameters: Protein Baseline (Day 1): n=6,6,6,2	78.8 Grams per liter Standard Deviation 12.78	73.3 Grams per liter Standard Deviation 5.50	76.7 Grams per liter Standard Deviation 10.03	73.5 Grams per liter Standard Deviation 0.71	—
Part 2: Absolute Values for Chemistry Parameters: Protein Day 7: n=6,6,6,1	76.7 Grams per liter Standard Deviation 12.01	72.5 Grams per liter Standard Deviation 5.13	78.2 Grams per liter Standard Deviation 8.93	72.0 Grams per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase Baseline (Day 1): Amylase, n=6,6,6,2	47.2 Units per liter Standard Deviation 18.15	51.0 Units per liter Standard Deviation 21.65	55.2 Units per liter Standard Deviation 18.61	56.0 Units per liter Standard Deviation 25.46	—
Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase Day 7: Amylase, n=6,6,6,1	44.8 Units per liter Standard Deviation 17.81	51.8 Units per liter Standard Deviation 22.71	61.8 Units per liter Standard Deviation 25.86	64.0 Units per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—
Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase Baseline (Day 1): Lipase, n=6,6,6,2	26.5 Units per liter Standard Deviation 14.08	29.7 Units per liter Standard Deviation 10.95	43.2 Units per liter Standard Deviation 32.32	26.0 Units per liter Standard Deviation 14.14	—
Part 2: Absolute Values for Chemistry Parameters: Amylase, Lipase Day 7: Lipase, n=6,6,6,1	25.5 Units per liter Standard Deviation 11.64	27.5 Units per liter Standard Deviation 13.40	47.7 Units per liter Standard Deviation 34.70	44.0 Units per liter Standard Deviation NA Standard deviation could not be calculated for single participant.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity Baseline (Day 1)	1.0238 Ratio Standard Deviation 0.00677	1.0233 Ratio Standard Deviation 0.00320	1.0240 Ratio Standard Deviation 0.00283	—	—
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity Days 8 to 10	1.0240 Ratio Standard Deviation 0.00533	1.0242 Ratio Standard Deviation 0.00279	1.0240 Ratio Standard Deviation 0.00000	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Urinalysis Parameter: Urobilinogen Baseline (Day 1)	3.40 Micromoles per liter Standard Deviation 0.000	3.40 Micromoles per liter Standard Deviation 0.000	3.40 Micromoles per liter Standard Deviation 0.000	—	—
Part 1: Absolute Values for Urinalysis Parameter: Urobilinogen Days 8 to 10	7.90 Micromoles per liter Standard Deviation 6.971	3.40 Micromoles per liter Standard Deviation 0.000	3.40 Micromoles per liter Standard Deviation 0.000	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Urine samples were collected at Baseline and one sample between Days 8 to 10 to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Urinalysis Parameter: pH Baseline (Day 1)	5.67 pH Standard Deviation 0.931	5.75 pH Standard Deviation 0.689	5.75 pH Standard Deviation 0.354	—	—
Part 1: Absolute Values for Urinalysis Parameter: pH Days 8 to 10	5.83 pH Standard Deviation 0.753	5.42 pH Standard Deviation 0.585	5.25 pH Standard Deviation 0.354	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity Baseline (Day 1)	1.0223 Ratio Standard Deviation 0.00866	1.0272 Ratio Standard Deviation 0.00360	1.0255 Ratio Standard Deviation 0.00918	1.0375 Ratio Standard Deviation 0.00495	—
Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity Day 7	1.0233 Ratio Standard Deviation 0.00686	1.0250 Ratio Standard Deviation 0.00522	1.0273 Ratio Standard Deviation 0.00327	1.0265 Ratio Standard Deviation 0.00919	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen Baseline (Day 1)	3.40 Micromoles per liter Standard Deviation 0.000	3.40 Micromoles per liter Standard Deviation 0.000	3.40 Micromoles per liter Standard Deviation 0.000	3.40 Micromoles per liter Standard Deviation 0.000	—
Part 2: Absolute Values for Urinalysis Parameter: Urobilinogen Day 7	3.40 Micromoles per liter Standard Deviation 0.000	7.90 Micromoles per liter Standard Deviation 6.971	3.40 Micromoles per liter Standard Deviation 0.000	3.40 Micromoles per liter Standard Deviation 0.000	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population.

Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Urinalysis Parameter: pH Baseline (Day 1)	5.33 pH Standard Deviation 0.258	5.83 pH Standard Deviation 0.753	5.25 pH Standard Deviation 0.418	5.50 pH Standard Deviation 0.000	—
Part 2: Absolute Values for Urinalysis Parameter: pH Day 7	5.50 pH Standard Deviation 0.775	5.67 pH Standard Deviation 0.258	5.33 pH Standard Deviation 0.258	5.75 pH Standard Deviation 0.354	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for SBP and DBP Baseline (Day 1): SBP	120.2 Millimeters of mercury Standard Deviation 13.36	121.8 Millimeters of mercury Standard Deviation 12.25	106.0 Millimeters of mercury Standard Deviation 11.31	—	—
Part 1: Absolute Values for SBP and DBP Days 8 to 10: SBP	117.7 Millimeters of mercury Standard Deviation 8.87	122.3 Millimeters of mercury Standard Deviation 7.94	104.5 Millimeters of mercury Standard Deviation 7.78	—	—
Part 1: Absolute Values for SBP and DBP Baseline (Day 1): DBP	70.3 Millimeters of mercury Standard Deviation 17.32	66.7 Millimeters of mercury Standard Deviation 10.80	64.0 Millimeters of mercury Standard Deviation 5.66	—	—
Part 1: Absolute Values for SBP and DBP Days 8 to 10: DBP	70.0 Millimeters of mercury Standard Deviation 6.81	67.5 Millimeters of mercury Standard Deviation 9.91	64.5 Millimeters of mercury Standard Deviation 4.95	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Respiratory Rate Baseline (Day 1)	16.0 Breaths per minute Standard Deviation 2.61	16.2 Breaths per minute Standard Deviation 3.31	15.0 Breaths per minute Standard Deviation 4.24	—	—
Part 1: Absolute Values for Respiratory Rate Days 8 to 10	15.0 Breaths per minute Standard Deviation 1.26	16.3 Breaths per minute Standard Deviation 2.73	14.0 Breaths per minute Standard Deviation 2.83	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Days 8 to 10)

Population: Safety Population.

Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for Pulse Rate Baseline (Day 1)	81.8 Beats per minute Standard Deviation 18.25	65.8 Beats per minute Standard Deviation 14.22	60.0 Beats per minute Standard Deviation 2.83	—	—
Part 1: Absolute Values for Pulse Rate Days 8 to 10	76.7 Beats per minute Standard Deviation 21.13	71.3 Beats per minute Standard Deviation 11.93	66.0 Beats per minute Standard Deviation 5.66	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population.

SBP and DBP were measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for SBP and DBP Baseline (Day 1): SBP	117.0 Millimeters of mercury Standard Deviation 7.95	116.5 Millimeters of mercury Standard Deviation 11.04	112.2 Millimeters of mercury Standard Deviation 9.93	105.5 Millimeters of mercury Standard Deviation 2.12	—
Part 2: Absolute Values for SBP and DBP Day 7: SBP	118.0 Millimeters of mercury Standard Deviation 12.07	114.3 Millimeters of mercury Standard Deviation 8.36	119.5 Millimeters of mercury Standard Deviation 8.87	106.5 Millimeters of mercury Standard Deviation 4.95	—
Part 2: Absolute Values for SBP and DBP Baseline (Day 1): DBP	71.5 Millimeters of mercury Standard Deviation 4.51	74.0 Millimeters of mercury Standard Deviation 4.69	71.8 Millimeters of mercury Standard Deviation 12.89	71.0 Millimeters of mercury Standard Deviation 12.73	—
Part 2: Absolute Values for SBP and DBP Day 7: DBP	69.7 Millimeters of mercury Standard Deviation 4.50	73.0 Millimeters of mercury Standard Deviation 5.06	74.2 Millimeters of mercury Standard Deviation 5.27	70.5 Millimeters of mercury Standard Deviation 4.95	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population.

Respiratory rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Respiratory Rate Day 7	17.2 Breaths per minute Standard Deviation 2.56	17.3 Breaths per minute Standard Deviation 2.07	16.2 Breaths per minute Standard Deviation 2.23	16.5 Breaths per minute Standard Deviation 2.12	—
Part 2: Absolute Values for Respiratory Rate Baseline (Day 1)	17.3 Breaths per minute Standard Deviation 2.66	17.2 Breaths per minute Standard Deviation 1.17	17.2 Breaths per minute Standard Deviation 2.40	16.0 Breaths per minute Standard Deviation 0.00	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Visit 5 (Day 7)

Population: Safety Population.

Pulse rate was measured in the semi-supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for Pulse Rate Day 7	72.5 Beats per minute Standard Deviation 16.34	76.5 Beats per minute Standard Deviation 7.87	79.8 Beats per minute Standard Deviation 12.45	75.0 Beats per minute Standard Deviation 5.66	—
Part 2: Absolute Values for Pulse Rate Baseline (Day 1)	68.3 Beats per minute Standard Deviation 9.91	74.5 Beats per minute Standard Deviation 8.36	77.0 Beats per minute Standard Deviation 10.16	64.5 Beats per minute Standard Deviation 13.44	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Visit 5 (Days 8 to 10: Pre-dose, 2, 4 and 6 hours)

Population: Safety Population.

Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval and QTcB interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals PR Interval- Days 8 to 10: 4 hours	136.5 Milliseconds Standard Deviation 12.10	168.7 Milliseconds Standard Deviation 13.81	173.0 Milliseconds Standard Deviation 28.28	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals PR Interval- Baseline (Day 1)	136.6 Milliseconds Standard Deviation 14.49	168.4 Milliseconds Standard Deviation 15.48	176.5 Milliseconds Standard Deviation 27.58	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals PR Interval- Days 8 to 10: Pre-dose	136.2 Milliseconds Standard Deviation 15.26	160.8 Milliseconds Standard Deviation 19.60	174.0 Milliseconds Standard Deviation 29.70	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals PR Interval- Days 8 to 10: 6 hours	138.0 Milliseconds Standard Deviation 9.10	162.5 Milliseconds Standard Deviation 15.06	151.5 Milliseconds Standard Deviation 23.33	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QRS Duration- Baseline (Day 1)	93.1 Milliseconds Standard Deviation 4.54	95.7 Milliseconds Standard Deviation 6.85	85.8 Milliseconds Standard Deviation 11.08	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QRS Duration- Days 8 to 10: Pre-dose	90.0 Milliseconds Standard Deviation 7.46	92.3 Milliseconds Standard Deviation 7.74	80.5 Milliseconds Standard Deviation 7.78	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QRS Duration- Days 8 to 10: 4 hours	89.8 Milliseconds Standard Deviation 5.91	94.0 Milliseconds Standard Deviation 6.42	84.5 Milliseconds Standard Deviation 14.85	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QRS Duration- Days 8 to 10: 6 hours	89.5 Milliseconds Standard Deviation 7.04	92.8 Milliseconds Standard Deviation 10.11	83.5 Milliseconds Standard Deviation 2.12	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QT Interval- Baseline (Day 1)	367.6 Milliseconds Standard Deviation 26.04	378.7 Milliseconds Standard Deviation 26.75	372.7 Milliseconds Standard Deviation 29.70	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QT Interval- Days 8 to 10: Pre-dose	368.3 Milliseconds Standard Deviation 23.35	376.0 Milliseconds Standard Deviation 31.46	353.0 Milliseconds Standard Deviation 8.49	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QT Interval- Days 8 to 10: 2 hours	365.2 Milliseconds Standard Deviation 25.39	383.2 Milliseconds Standard Deviation 26.84	344.0 Milliseconds Standard Deviation 25.46	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcB Interval- Days 8 to 10: 2 hours	401.70 Milliseconds Standard Deviation 37.316	393.15 Milliseconds Standard Deviation 26.290	361.05 Milliseconds Standard Deviation 7.283	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcB Interval- Days 8 to 10: 4 hours	412.92 Milliseconds Standard Deviation 42.143	387.38 Milliseconds Standard Deviation 24.454	358.20 Milliseconds Standard Deviation 12.162	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcB Interval- Days 8 to 10: 6 hours	414.80 Milliseconds Standard Deviation 34.569	388.60 Milliseconds Standard Deviation 23.893	383.55 Milliseconds Standard Deviation 28.496	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcF Interval- Days 8 to 10: Pre-dose	397.3 Milliseconds Standard Deviation 25.34	392.3 Milliseconds Standard Deviation 20.64	375.5 Milliseconds Standard Deviation 24.75	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcF Interval- Days 8 to 10: 2 hours	388.7 Milliseconds Standard Deviation 22.72	389.8 Milliseconds Standard Deviation 22.89	355.5 Milliseconds Standard Deviation 13.44	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcF Interval- Days 8 to 10: 6 hours	400.2 Milliseconds Standard Deviation 19.22	387.3 Milliseconds Standard Deviation 22.03	371.0 Milliseconds Standard Deviation 21.21	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals PR Interval- Days 8 to 10: 2 hours	138.0 Milliseconds Standard Deviation 14.46	162.2 Milliseconds Standard Deviation 11.53	165.0 Milliseconds Standard Deviation 28.28	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QRS Duration- Days 8 to 10: 2 hours	91.0 Milliseconds Standard Deviation 6.36	96.2 Milliseconds Standard Deviation 7.17	86.0 Milliseconds Standard Deviation 7.07	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QT Interval- Days 8 to 10: 4 hours	376.3 Milliseconds Standard Deviation 22.70	387.7 Milliseconds Standard Deviation 29.34	347.5 Milliseconds Standard Deviation 10.61	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QT Interval- Days 8 to 10: 6 hours	373.3 Milliseconds Standard Deviation 26.48	384.5 Milliseconds Standard Deviation 25.37	348.5 Milliseconds Standard Deviation 7.78	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcB Interval- Baseline (Day 1)	412.15 Milliseconds Standard Deviation 31.539	397.75 Milliseconds Standard Deviation 22.914	388.43 Milliseconds Standard Deviation 39.598	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcB Interval- Days 8 to 10: Pre-dose	413.80 Milliseconds Standard Deviation 42.176	401.35 Milliseconds Standard Deviation 22.923	387.05 Milliseconds Standard Deviation 33.163	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcF Interval- Baseline (Day 1)	396.2 Milliseconds Standard Deviation 17.67	391.2 Milliseconds Standard Deviation 19.11	383.2 Milliseconds Standard Deviation 36.06	—	—
Part 1: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcF Interval- Days 8 to 10: 4 hours	399.8 Milliseconds Standard Deviation 25.87	387.5 Milliseconds Standard Deviation 21.27	354.5 Milliseconds Standard Deviation 4.95	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Visit 5 (Day 7: Pre-dose, 2, 4 and 6 hours)

Population: Safety Population.

Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval and QTcB interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=2 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals PR Interval- Baseline (Day 1)	156.8 Milliseconds Standard Deviation 33.02	162.9 Milliseconds Standard Deviation 29.73	162.8 Milliseconds Standard Deviation 20.83	144.3 Milliseconds Standard Deviation 6.13	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals PR Interval- Day 7: Pre-dose	166.5 Milliseconds Standard Deviation 25.62	161.8 Milliseconds Standard Deviation 31.06	155.5 Milliseconds Standard Deviation 26.10	137.0 Milliseconds Standard Deviation 5.66	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QRS Duration- Day 7: 4 hours	94.3 Milliseconds Standard Deviation 8.89	95.2 Milliseconds Standard Deviation 18.94	85.8 Milliseconds Standard Deviation 4.88	89.5 Milliseconds Standard Deviation 7.78	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QRS Duration- Day 7: 6 hours	93.2 Milliseconds Standard Deviation 10.61	95.0 Milliseconds Standard Deviation 21.29	88.2 Milliseconds Standard Deviation 8.11	88.5 Milliseconds Standard Deviation 17.68	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QT Interval- Baseline (Day 1)	386.6 Milliseconds Standard Deviation 28.86	355.9 Milliseconds Standard Deviation 25.37	362.5 Milliseconds Standard Deviation 19.45	378.8 Milliseconds Standard Deviation 1.18	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcF Interval- Baseline (Day 1)	397.4 Milliseconds Standard Deviation 24.60	383.5 Milliseconds Standard Deviation 23.72	394.1 Milliseconds Standard Deviation 12.71	397.3 Milliseconds Standard Deviation 13.67	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QT Interval- Day 7: Pre-dose	379.2 Milliseconds Standard Deviation 33.30	354.3 Milliseconds Standard Deviation 31.94	367.5 Milliseconds Standard Deviation 26.93	382.0 Milliseconds Standard Deviation 1.41	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QT Interval- Day 7: 2 hours	362.2 Milliseconds Standard Deviation 31.24	351.5 Milliseconds Standard Deviation 25.05	364.3 Milliseconds Standard Deviation 17.32	378.5 Milliseconds Standard Deviation 4.95	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals PR Interval- Day 7: 2 hours	162.8 Milliseconds Standard Deviation 28.34	160.5 Milliseconds Standard Deviation 28.73	159.7 Milliseconds Standard Deviation 26.04	150.5 Milliseconds Standard Deviation 3.54	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals PR Interval- Day 7: 4 hours	162.0 Milliseconds Standard Deviation 24.85	164.0 Milliseconds Standard Deviation 31.51	154.5 Milliseconds Standard Deviation 20.51	149.0 Milliseconds Standard Deviation 11.31	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals PR Interval- Day 7: 6 hours	160.7 Milliseconds Standard Deviation 24.81	160.7 Milliseconds Standard Deviation 27.25	160.7 Milliseconds Standard Deviation 25.90	136.5 Milliseconds Standard Deviation 3.54	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QRS Duration- Baseline (Day 1)	92.6 Milliseconds Standard Deviation 10.22	95.1 Milliseconds Standard Deviation 21.97	88.9 Milliseconds Standard Deviation 7.40	85.7 Milliseconds Standard Deviation 11.31	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QRS Duration- Day 7: Pre-dose	96.5 Milliseconds Standard Deviation 8.14	98.3 Milliseconds Standard Deviation 28.86	88.5 Milliseconds Standard Deviation 3.99	88.0 Milliseconds Standard Deviation 4.24	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QRS Duration- Day 7: 2 hours	95.0 Milliseconds Standard Deviation 9.78	95.8 Milliseconds Standard Deviation 19.29	88.8 Milliseconds Standard Deviation 4.49	90.0 Milliseconds Standard Deviation 12.73	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QT Interval- Day 7: 4 hours	373.8 Milliseconds Standard Deviation 24.25	360.2 Milliseconds Standard Deviation 23.07	360.8 Milliseconds Standard Deviation 18.64	390.0 Milliseconds Standard Deviation 18.38	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QT Interval- Day 7: 6 hours	365.2 Milliseconds Standard Deviation 34.53	361.8 Milliseconds Standard Deviation 25.88	363.2 Milliseconds Standard Deviation 19.50	381.5 Milliseconds Standard Deviation 6.36	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcB Interval- Baseline (Day 1)	402.88 Milliseconds Standard Deviation 26.814	398.24 Milliseconds Standard Deviation 25.587	411.18 Milliseconds Standard Deviation 15.858	406.73 Milliseconds Standard Deviation 20.742	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcB Interval- Day 7: Pre-dose	398.72 Milliseconds Standard Deviation 26.663	398.58 Milliseconds Standard Deviation 21.075	414.63 Milliseconds Standard Deviation 17.816	399.65 Milliseconds Standard Deviation 18.173	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcB Interval- Day 7: 2 hours	405.78 Milliseconds Standard Deviation 10.923	398.33 Milliseconds Standard Deviation 33.672	406.30 Milliseconds Standard Deviation 27.565	388.50 Milliseconds Standard Deviation 17.819	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcB Interval- Day 7: 4 hours	395.92 Milliseconds Standard Deviation 22.851	397.68 Milliseconds Standard Deviation 20.635	412.48 Milliseconds Standard Deviation 27.377	382.90 Milliseconds Standard Deviation 17.961	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcB Interval- Day 7: 6 hours	399.62 Milliseconds Standard Deviation 19.074	402.42 Milliseconds Standard Deviation 22.916	409.50 Milliseconds Standard Deviation 19.009	396.90 Milliseconds Standard Deviation 3.253	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcF Interval- Day 7: Pre-dose	391.5 Milliseconds Standard Deviation 24.01	383.0 Milliseconds Standard Deviation 24.90	398.2 Milliseconds Standard Deviation 18.58	394.0 Milliseconds Standard Deviation 12.73	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcF Interval- Day 7: 2 hours	390.2 Milliseconds Standard Deviation 12.16	382.2 Milliseconds Standard Deviation 30.20	391.8 Milliseconds Standard Deviation 22.44	385.0 Milliseconds Standard Deviation 14.14	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcF Interval- Day 7: 4 hours	388.0 Milliseconds Standard Deviation 18.21	384.7 Milliseconds Standard Deviation 20.42	394.7 Milliseconds Standard Deviation 18.91	385.0 Milliseconds Standard Deviation 18.38	—
Part 2: Absolute Values for ECG Parameters: PR, QRS, QT, QTcB and QTcF Intervals QTcF Interval- Day 7: 6 hours	387.8 Milliseconds Standard Deviation 11.29	388.0 Milliseconds Standard Deviation 21.76	393.3 Milliseconds Standard Deviation 17.20	391.5 Milliseconds Standard Deviation 4.95	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Pharmacokinetic (PK) Population consisted of all participants who received GSK3640254 and underwent plasma PK sampling during the study.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=5 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Area Under the Plasma Concentration Time Curve From Zero to 24 (AUC[0-24]) Following Administration of GSK3640254 on Day 1	0.6946 Hours*microgram per milliliter Geometric Coefficient of Variation 13.5	12.3929 Hours*microgram per milliliter Geometric Coefficient of Variation 91.3	—	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK3640254 on Day 1	0.0591 Microgram per milliliter Geometric Coefficient of Variation 177.4	0.9381 Microgram per milliliter Geometric Coefficient of Variation 82.3	—	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Time to Maximum Observed Concentration (Tmax) Following Administration of GSK3640254 on Day 1	2.9250 Hours Interval 0.0 to 5.0	5.5250 Hours Interval 3.917 to 8.05	—	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Concentration at 24 Hours Post-dose (C24) Following Administration of GSK3640254 on Day 1	0.0180 Microgram per milliliter Geometric Coefficient of Variation 27.5	0.3553 Microgram per milliliter Geometric Coefficient of Variation 92.7	—	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Absorption Lag Time (Tlag) Following Administration of GSK3640254 on Day 1	0.500 Hours Interval 0.0 to 1.0	0.000 Hours Interval 0.0 to 1.0	—	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: AUC(0-24) Following Administration of GSK3640254 on Day 1	3.2527 Hours*microgram per milliliter Geometric Coefficient of Variation 31.7	6.1228 Hours*microgram per milliliter Geometric Coefficient of Variation 38.8	14.0335 Hours*microgram per milliliter Geometric Coefficient of Variation 36.6	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Cmax Following Administration of GSK3640254 on Day 1	0.2316 Microgram per milliliter Geometric Coefficient of Variation 30.5	0.4329 Microgram per milliliter Geometric Coefficient of Variation 33.6	0.9178 Microgram per milliliter Geometric Coefficient of Variation 41.5	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Tmax Following Administration of GSK3640254 on Day 1	4.4167 Hours Interval 3.967 to 8.0	4.0750 Hours Interval 2.95 to 6.167	5.5083 Hours Interval 3.0 to 6.25	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: C24 Following Administration of GSK3640254 on Day 1	0.0951 Microgram per milliliter Geometric Coefficient of Variation 33.7	0.1856 Microgram per milliliter Geometric Coefficient of Variation 36.2	0.4207 Microgram per milliliter Geometric Coefficient of Variation 33.8	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Tlag Following Administration of GSK3640254 on Day 1	0.483 Hours Interval 0.0 to 2.0	0.000 Hours Interval 0.0 to 1.0	0.000 Hours Interval 0.0 to 1.0	—	—

SECONDARY outcome

Timeframe: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Area Under the Plasma Drug Concentration-time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10	0.9082 Hours*microgram per milliliter Geometric Coefficient of Variation 44.7	27.9363 Hours*microgram per milliliter Geometric Coefficient of Variation 18.4	—	—	—

SECONDARY outcome

Timeframe: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Cmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10	0.0549 Microgram per milliliter Geometric Coefficient of Variation 41.3	1.8559 Microgram per milliliter Geometric Coefficient of Variation 19.5	—	—	—

SECONDARY outcome

Timeframe: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Tmax Following Repeat Dose Administration of GSK3640254 on Days 8 to 10	4.0167 Hours Interval 1.867 to 5.0	5.4833 Hours Interval 3.0 to 6.2	—	—	—

SECONDARY outcome

Timeframe: Days 8 to 10: Pre-dose

Population: PK Population. Only those participants with data available at the specified time points were analyzed.

Blood sample was collected at indicated time point for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=5 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Pre-dose Concentration (C0) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10	0.0268 Microgram per milliliter Geometric Coefficient of Variation 41.6	0.6928 Microgram per milliliter Geometric Coefficient of Variation 33.6	—	—	—

SECONDARY outcome

Timeframe: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Concentration at End of Dosing Interval (Ctau) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10	0.0267 Microgram per milliliter Geometric Coefficient of Variation 47.0	0.7033 Microgram per milliliter Geometric Coefficient of Variation 29.6	—	—	—

SECONDARY outcome

Timeframe: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Apparent Terminal Phase Half-life (t1/2) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10	NA Hours t1/2 could not be calculated as the criteria of a span ratio \[ratio of half-life to time used for half-life calculation\] for at least 2 participants could not be fulfilled due to lack of available data.	NA Hours t1/2 could not be calculated as the criteria of a span ratio \[ratio of half-life to time used for half-life calculation\] for at least 2 participants could not be fulfilled due to lack of available data.	—	—	—

SECONDARY outcome

Timeframe: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Apparent Oral Clearance (CL/F) Following Repeat Dose Administration of GSK3640254 on Days 8 to 10	11010.5393 Milliliter per hour Geometric Coefficient of Variation 44.7	7159.1443 Milliliter per hour Geometric Coefficient of Variation 18.4	—	—	—

SECONDARY outcome

Timeframe: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: AUC(0-tau) Following Repeat Dose Administration of GSK3640254 on Day 7	7.4626 Hours*microgram per milliliter Geometric Coefficient of Variation 26.8	11.8256 Hours*microgram per milliliter Geometric Coefficient of Variation 26.7	29.2952 Hours*microgram per milliliter Geometric Coefficient of Variation 27.9	—	—

SECONDARY outcome

Timeframe: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Cmax Following Repeat Dose Administration of GSK3640254 on Day 7	0.4692 Microgram per milliliter Geometric Coefficient of Variation 20.6	0.7470 Microgram per milliliter Geometric Coefficient of Variation 23.7	1.8574 Microgram per milliliter Geometric Coefficient of Variation 26.0	—	—

SECONDARY outcome

Timeframe: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Tmax Following Repeat Dose Administration of GSK3640254 on Day 7	4.0583 Hours Interval 2.0 to 8.0	4.5750 Hours Interval 4.0 to 5.183	4.0750 Hours Interval 2.917 to 5.2	—	—

SECONDARY outcome

Timeframe: Day 7: Pre-dose

Population: PK Population.

Blood sample was collected at indicated time point for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: C0 Following Repeat Dose Administration of GSK3640254 on Day 7	0.2155 Microgram per milliliter Geometric Coefficient of Variation 24.2	0.3575 Microgram per milliliter Geometric Coefficient of Variation 38.0	0.7520 Microgram per milliliter Geometric Coefficient of Variation 38.8	—	—

SECONDARY outcome

Timeframe: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Ctau Following Repeat Dose Administration of GSK3640254 on Day 7	0.2187 Microgram per milliliter Geometric Coefficient of Variation 30.1	0.3599 Microgram per milliliter Geometric Coefficient of Variation 31.1	0.7979 Microgram per milliliter Geometric Coefficient of Variation 34.1	—	—

SECONDARY outcome

Timeframe: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: t1/2 Following Repeat Dose Administration of GSK3640254 on Day 7	NA Hours t1/2 could not be calculated as the criteria of a span ratio \[ratio of half-life to time used for half-life calculation\] for at least 2 participants could not be fulfilled due to lack of available data.	NA Hours t1/2 could not be calculated as the criteria of a span ratio \[ratio of half-life to time used for half-life calculation\] for at least 2 participants could not be fulfilled due to lack of available data.	NA Hours t1/2 could not be calculated as the criteria of a span ratio \[ratio of half-life to time used for half-life calculation\] for at least 2 participants could not be fulfilled due to lack of available data.	—	—

SECONDARY outcome

Timeframe: Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: CL/F Following Repeat Dose Administration of GSK3640254 on Day 7	5360.0526 Milliliter per hour Geometric Coefficient of Variation 26.8	6764.9862 Milliliter per hour Geometric Coefficient of Variation 26.7	4778.9430 Milliliter per hour Geometric Coefficient of Variation 27.9	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 8

Population: PK/PD Population.

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Statistical analysis for relationship between PK parameters (AUC) and PD measures (Change from Baseline in plasma HIV-1 RNA) were explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: maximum response (Emax), PK parameter value that attains 50 percent (%) of the maximal effect (EC50) and residual variability (s2e). PK/PD Population consisted of participants who met criteria for Per-Protocol and Pharmacokinetic Population analysis sets and who underwent PD sampling during the study.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=6 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg n=6 Participants Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 AUC(0-tau)	12071.4 Copies per milliliter Standard Deviation 42117.29	-113331.4 Copies per milliliter Standard Deviation 89475.00	-48655.0 Copies per milliliter Standard Deviation 26269.41	-37904.3 Copies per milliliter Standard Deviation 38814.54	-64861.5 Copies per milliliter Standard Deviation 83728.15

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 8

Population: PK/PD Population.

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Statistical analysis for relationship between PK parameters (Cmax) and PD measures (Change from Baseline in plasma HIV-1 RNA) were explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: Emax, EC50 and s2e.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=6 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg n=6 Participants Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Cmax	12071.4 Copies per milliliter Standard Deviation 42117.29	-113331.4 Copies per milliliter Standard Deviation 89475.00	-48655.0 Copies per milliliter Standard Deviation 26269.41	-37904.3 Copies per milliliter Standard Deviation 38814.54	-64861.5 Copies per milliliter Standard Deviation 83728.15

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 8

Population: PK/PD Population.

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Statistical analysis for relationship between PK parameters (Ctau) and PD measures (Change from Baseline in plasma HIV-1 RNA) were explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: Emax, EC50 and s2e.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo n=6 Participants Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg n=6 Participants Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1 and Part 2: Change From Baseline in Plasma HIV-1 RNA Relative to Day 8 Ctau	12071.4 Copies per milliliter Standard Deviation 42117.29	-113331.4 Copies per milliliter Standard Deviation 89475.00	-48655.0 Copies per milliliter Standard Deviation 26269.41	-37904.3 Copies per milliliter Standard Deviation 38814.54	-64861.5 Copies per milliliter Standard Deviation 83728.15

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The accumulation ratios (Ro) were calculated as Ro_AUC equal to (=) AUC(0-tau) Days 8 to 10 divided by (/) AUC(0-24) Day 1; Ro_Cmax=Cmax Days 8 to 10/Cmax Day 1; and Ro_Ctau=Ctau Days 8 to 10/C24 Day 1.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 Ro_AUC(0-tau), n=5,6	1.5352 Ratio Geometric Coefficient of Variation 24.5	2.2542 Ratio Geometric Coefficient of Variation 72.1	—	—	—
Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 Ro_Cmax, n=6,6	0.9287 Ratio Geometric Coefficient of Variation 171.7	1.9785 Ratio Geometric Coefficient of Variation 69.4	—	—	—
Part 1: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 Ro_Ctau, n=6,6	1.4790 Ratio Geometric Coefficient of Variation 22.2	1.9796 Ratio Geometric Coefficient of Variation 61.2	—	—	—

SECONDARY outcome

Timeframe: Days 1 and 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The accumulation ratios (Ro) were calculated as Ro_AUC=AUC(0-tau) Day 7/AUC(0-24) Day 1; Ro_Cmax=Cmax Day 7/Cmax Day 1; and Ro_Ctau=Ctau Day 7/C24 Day 1.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=6 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 Participants Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=6 Participants Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 Ro_AUC(0-tau)	2.2943 Ratio Geometric Coefficient of Variation 11.2	1.9314 Ratio Geometric Coefficient of Variation 18.6	2.0875 Ratio Geometric Coefficient of Variation 29.2	—	—
Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 Ro_Cmax	2.0258 Ratio Geometric Coefficient of Variation 24.4	1.7258 Ratio Geometric Coefficient of Variation 17.6	2.0236 Ratio Geometric Coefficient of Variation 37.5	—	—
Part 2: Accumulation Ratio Following Repeat Dose Administration of GSK3640254 Ro_Ctau	2.2985 Ratio Geometric Coefficient of Variation 6.4	1.9389 Ratio Geometric Coefficient of Variation 20.8	1.8967 Ratio Geometric Coefficient of Variation 16.0	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=30 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on AUC(0-24)	1.018 Slope of log dose Interval 0.876 to 1.16	—	—	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=30 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on Cmax	0.964 Slope of log dose Interval 0.774 to 1.154	—	—	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=30 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1 and Part 2: Dose Proportionality of GSK3640254 Administered on Day 1 Based on C24	1.061 Slope of log dose Interval 0.924 to 1.199	—	—	—	—

SECONDARY outcome

Timeframe: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=30 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on AUC(0-tau)	1.179 Slope of log dose Interval 1.074 to 1.283	—	—	—	—

SECONDARY outcome

Timeframe: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=30 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Cmax	1.204 Slope of log dose Interval 1.107 to 1.302	—	—	—	—

SECONDARY outcome

Timeframe: Days 8 to 10: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose; Day 7: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose

Population: PK Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis. Dose proportionality was assessed using Power model with logarithm of dose as fixed effect. Slope and 90% confidence interval for the slope are presented.

Outcome measures

Measure	Part 1: GSK3640254 10 mg n=30 Participants Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: Placebo Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Part 1 and Part 2: Dose Proportionality of GSK3640254 Following Repeat Dose Administration Based on Ctau	1.137 Slope of log dose Interval 1.018 to 1.257	—	—	—	—

Adverse Events

Part 1: GSK3640254 10 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: GSK3640254 200 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: GSK3640254 40 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 2: GSK3640254 80 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2: GSK3640254 140 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1: GSK3640254 10 mg n=6 participants at risk Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 participants at risk Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 participants at risk Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: GSK3640254 40 mg n=6 participants at risk Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 80 mg n=6 participants at risk Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg n=6 participants at risk Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: Placebo n=2 participants at risk Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Infections and infestations Anal abscess	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Cardiac disorders Congestive cardiomyopathy	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.

Other adverse events

Measure	Part 1: GSK3640254 10 mg n=6 participants at risk Participants received GSK3640254 10 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: GSK3640254 200 mg n=6 participants at risk Participants received GSK3640254 200 mg, capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 1: Placebo n=2 participants at risk Participants received placebo capsules, orally for 10 days. Participants were followed for up to 14 days post last dose of study treatment.	Part 2: GSK3640254 40 mg n=6 participants at risk Participants received GSK3640254 40 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 80 mg n=6 participants at risk Participants received GSK3640254 80 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: GSK3640254 140 mg n=6 participants at risk Participants received GSK3640254 140 mg, capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.	Part 2: Placebo n=2 participants at risk Participants received placebo capsules, orally for 7 days. Participants were followed for up to 5 days post last dose of study treatment.
Nervous system disorders Headache	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	33.3% 2/6 • Number of events 2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	33.3% 2/6 • Number of events 2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	33.3% 2/6 • Number of events 3 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Blood and lymphatic system disorders Lymphadenopathy	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	33.3% 2/6 • Number of events 2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Investigations Alanine aminotransferase increased	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Investigations Aspartate aminotransferase increased	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
General disorders Asthenia	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Renal and urinary disorders Chromaturia	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Gastrointestinal disorders Constipation	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
General disorders Fatigue	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Metabolism and nutrition disorders Hyperglycaemia	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Metabolism and nutrition disorders Insulin resistance	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Infections and infestations Meningococcal infection	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Nervous system disorders Migraine	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Cardiac disorders Myocarditis	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
General disorders Nodule	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Infections and infestations Pharyngitis	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Nervous system disorders Presyncope	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
General disorders Pyrexia	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Musculoskeletal and connective tissue disorders Spinal pain	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Infections and infestations Urinary tract infection	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Infections and infestations Viral infection	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.
Metabolism and nutrition disorders Vitamin D deficiency	16.7% 1/6 • Number of events 1 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/6 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.	0.00% 0/2 • Part 1: up to Day 24; Part 2: up to Day 12 Safety Population consisted of all participants who were enrolled into the study with documented evidence of having received at least 1 dose of randomized treatment.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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