Study to Evaluate the Pharmacokinetic (PK) Interactions Between GSK3640254 and Dolutegravir (DTG)

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03816696
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

This is an open-label, single-sequence, two-way drug interaction study to investigate the PK, safety and tolerability of GSK3640254 and DTG when administered alone or in combination in healthy subjects. Treatment of human immunodeficiency virus (HIV) infection frequently involves combination therapy. Data from this study will contribute to dosing recommendations when GSK3640254 and DTG are given in combination. The study will consist of a Screening period and 3 sequential treatment periods. Subjects will be administered DTG 50 milligrams (mg) once daily (QD) in Period 1 followed by GSK3640254 200 mg QD in Period 2. There will be a washout period of 4 days between Periods 1 and 2. In Period 3, subjects will be co-administered DTG 50 mg QD and GSK3640254 200 mg QD. The total duration of the study will be approximately 55 days, including Screening.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: GSK3640254; Drug: DTG	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Two-way Interaction Clinical Trial to Evaluate the Pharmacokinetic Interactions Between GSK3640254 and Dolutegravir in Healthy Subjects
• Actual Study Start Date: Jan 23, 2019
• Actual Primary Completion Date: Mar 30, 2019
• Actual Study Completion Date: Apr 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DTG followed by GSK3640254 followed by DTG+GSK3640254 Subjects will receive DTG 50 mg QD on Days 1 through 5 in Period 1 followed by a wash-out period of 4 days. Subjects will then receive GSK3640254 200 mg QD on Days 1 through 7 in Period 2 followed by co-administration of DTG 50 mg QD with GSK3640254 200 mg QD on Days 1 through 7 in Period 3.	Drug: GSK3640254; GSK3640254 will be available as 100 mg capsules. Subjects will be administered GSK3640254 200 mg QD via the oral route.; Drug: DTG; DTG will be available as 50 mg tablets. Subjects will be administered DTG 50 mg QD via the oral route.

Outcome Measures

Primary Outcome Measures

1. Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing (AUC[0 to Tau]) of Dolutegravir for Dolutegravir Arm [Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

   Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic Parameter Population consisted of all participants who underwent plasma pharmacokinetic sampling and had evaluable pharmacokinetic parameters estimated.

2. Period 3: AUC(0 to Tau) of Dolutegravir for Dolutegravir + GSK3640254 Arm [Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

3. Period 1: Maximum Observed Concentration (Cmax) of Dolutegravir for Dolutegravir Arm [Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

4. Period 3: Cmax of Dolutegravir for Dolutegravir + GSK3640254 Arm [Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

5. Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of Dolutegravir for Dolutegravir Arm [Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

6. Period 3: Ctau of Dolutegravir for Dolutegravir + GSK3640254 Arm [Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

7. Period 2: AUC(0 to Tau) of GSK3640254 for GSK3640254 Arm [Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

8. Period 3: AUC(0 to Tau) of GSK3640254 for Dolutegravir + GSK3640254 Arm [Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

9. Period 2: Cmax of GSK3640254 for GSK3640254 Arm [Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

10. Period 3: Cmax of GSK3640254 for Dolutegravir + GSK3640254 Arm [Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

11. Period 2: Ctau of GSK3640254 for GSK3640254 Arm [Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

12. Period 3: Ctau of GSK3640254 for Dolutegravir + GSK3640254 Arm [Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

Secondary Outcome Measures

1. Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) [Up to Day 27]

   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; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication.

2. Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count [Baseline (Day -1) and at Day 9]

   Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

3. Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count [Baseline (Period 1 Day 9) and at Day 7]

   Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

4. Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

   Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

5. Period 1: Change From Baseline in Hematology Parameter: Hemoglobin [Baseline (Day -1) and at Day 9]

   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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

6. Period 2: Change From Baseline in Hematology Parameter: Hemoglobin [Baseline (Period 1 Day 9) and at Day 7]

   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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

7. Period 3: Change From Baseline in Hematology Parameter: Hemoglobin [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

   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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

8. Period 1: Change From Baseline in Hematology Parameter: Hematocrit [Baseline (Day -1) and at Day 9]

   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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

9. Period 2: Change From Baseline in Hematology Parameter: Hematocrit [Baseline (Period 1 Day 9) and at Day 7]

   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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

10. Period 3: Change From Baseline in Hematology Parameter: Hematocrit [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

    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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

11. Period 1: Change From Baseline in Hematology Parameter: Erythrocytes [Baseline (Day -1) and at Day 9]

    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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

12. Period 2: Change From Baseline in Hematology Parameter: Erythrocytes [Baseline (Period 1 Day 9) and at Day 7]

    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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

13. Period 3: Change From Baseline in Hematology Parameter: Erythrocytes [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

    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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

14. Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume [Baseline (Day -1) and at Day 9]

    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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

15. Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume [Baseline (Period 1 Day 9) and at Day 7]

    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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

16. Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

    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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

17. Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin [Baseline (Day -1) and at Day 9]

    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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

18. Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin [Baseline (Period 1 Day 9) and at Day 7]

    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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

19. Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

    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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

20. Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen [Baseline (Day -1) and at Day 9]

    Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

21. Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen [Baseline (Period 1 Day 9) and at Day 7]

    Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

22. Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

    Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

23. Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase [Baseline (Day -1) and at Day 9]

    Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

24. Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase [Baseline (Period 1 Day 9) and at Day 7]

    Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

25. Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

    Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

26. Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin [Baseline (Day -1) and at Day 9]

    Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

27. Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin [Baseline (Period 1 Day 9) and at Day 7]

    Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

28. Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

    Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

29. Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein [Baseline (Day -1) and at Day 9]

    Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

30. Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein [Baseline (Period 1 Day 9) and at Day 7]

    Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

31. Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

    Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

32. Period 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase [Baseline (Day -1) and at Day 9]

    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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

33. Period 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase [Baseline (Period 1 Day 9) and at Day 7]

    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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

34. Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

    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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

35. Period 1: Change From Baseline in Urinalysis Parameter: Specific Gravity [Baseline (Day -1) and at Day 9]

    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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

36. Period 2: Change From Baseline in Urinalysis Parameter: Specific Gravity [Baseline (Period 1 Day 9) and at Day 7]

    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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

37. Period 3: Change From Baseline in Urinalysis Parameter: Specific Gravity [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

    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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

38. Period 1: Change From Baseline in Urinalysis Parameter: Urobilinogen [Baseline (Day -1) and at Day 9]

    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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

39. Period 2: Change From Baseline in Urinalysis Parameter: Urobilinogen [Baseline (Period 1 Day 9) and at Day 7]

    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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

40. Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

    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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

41. Period 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) [Baseline (Day -1) and at Day 9]

    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 acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

42. Period 2: Change From Baseline in Urinalysis Parameter: pH [Baseline (Period 1 Day 9) and at Day 7]

    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 acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

43. Period 3: Change From Baseline in Urinalysis Parameter: pH [Baseline (Period 2 Day 7) and at Days 4, 7 and 10]

    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 acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

44. Period 1: Number of Participants With Urinalysis Dipstick Results [Day 9]

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present) and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample.

45. Period 2: Number of Participants With Urinalysis Dipstick Results [Day 7]

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample.

46. Period 3: Number of Participants With Urinalysis Dipstick Results [Days 4, 7 and 10]

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present)indicating proportional concentrations in the urine sample.

47. Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) [Baseline, Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours]

    Twelve-lead electrocardiograms (ECG) were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

48. Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB [Baseline; Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours]

    Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

49. Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB [Baseline; Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10]

    Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

50. Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5]

    SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

51. Period 2: Change From Baseline in SBP and DBP [Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7]

    SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

52. Period 3: Change From Baseline in SBP and DBP [Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11]

    SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

53. Period 1: Change From Baseline in Pulse Rate [Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5]

    Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

54. Period 2: Change From Baseline in Pulse Rate [Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7]

    Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

55. Period 3: Change From Baseline in Pulse Rate [Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11]

    Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

56. Period 1: Change From Baseline in Respiratory Rate [Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5]

    Respiratory rate was measured in the semi-recumbent position 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, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

57. Period 2: Change From Baseline in Respiratory Rate [Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7]

    Respiratory rate was measured in the semi-recumbent position 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, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

58. Period 3: Change From Baseline in Respiratory Rate [Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11]

    Respiratory rate was measured in the semi-recumbent position 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, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

59. Period 1: Change From Baseline in Body Temperature [Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5]

    Body temperature was measured in the semi-recumbent position 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, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

60. Period 2: Change From Baseline in Body Temperature [Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7]

    Body temperature was measured in the semi-recumbent position 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, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

61. Period 3: Change From Baseline in Body Temperature [Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11]

    Body temperature was measured in the semi-recumbent position 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, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

62. Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count [Day 9]

    Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.

63. Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count [Day 7]

    Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.

64. Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count [Days 4, 7 and 10]

    Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.

65. Period 1: Absolute Values for Hematology Parameter: Hemoglobin [Day 9]

    Blood samples were collected to analyze the hematology parameter: hemoglobin.

66. Period 2: Absolute Values for Hematology Parameter: Hemoglobin [Day 7]

    Blood samples were collected to analyze the hematology parameter: hemoglobin.

67. Period 3: Absolute Values for Hematology Parameter: Hemoglobin [Days 4, 7 and 10]

    Blood samples were collected to analyze the hematology parameter: hemoglobin.

68. Period 1: Absolute Values for Hematology Parameter: Hematocrit [Day 9]

    Blood samples were collected to analyze the hematology parameter: hematocrit.

69. Period 2: Absolute Values for Hematology Parameter: Hematocrit [Day 7]

    Blood samples were collected to analyze the hematology parameter: hematocrit.

70. Period 3: Absolute Values for Hematology Parameter: Hematocrit [Days 4, 7 and 10]

    Blood samples were collected to analyze the hematology parameter: hematocrit.

71. Period 1: Absolute Values for Hematology Parameter: Erythrocytes [Day 9]

    Blood samples were collected to analyze the hematology parameter: erythrocytes.

72. Period 2: Absolute Values for Hematology Parameter: Erythrocytes [Day 7]

    Blood samples were collected to analyze the hematology parameter: erythrocytes.

73. Period 3: Absolute Values for Hematology Parameter: Erythrocytes [Days 4, 7 and 10]

    Blood samples were collected to analyze the hematology parameter: erythrocytes.

74. Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume [Day 9]

    Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.

75. Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume [Day 7]

    Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.

76. Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume [Days 4, 7 and 10]

    Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.

77. Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin [Day 9]

    Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.

78. Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin [Day 7]

    Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.

79. Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin [Days 4, 7 and 10]

    Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.

80. Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen [Day 9]

    Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.

81. Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen [Day 7]

    Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.

82. Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen [Days 4, 7 and 10]

    Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.

83. Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase [Day 9]

    Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.

84. Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase [Day 7]

    Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.

85. Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase [Days 4, 7 and 10]

    Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.

86. Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin [Day 9]

    Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.

87. Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin [Day 7]

    Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.

88. Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin [Days 4, 7 and 10]

    Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.

89. Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein [Day 9]

    Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.

90. Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein [Day 7]

    Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.

91. Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein [Days 4, 7 and 10]

    Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.

92. Period 1: Absolute Values for Chemistry Parameters: Amylase, Lipase [Day 9]

    Blood samples were collected to analyze the chemistry parameters: amylase and lipase.

93. Period 2: Absolute Values for Chemistry Parameters: Amylase, Lipase [Day 7]

    Blood samples were collected to analyze the chemistry parameters: amylase and lipase.

94. Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase [Days 4, 7 and 10]

    Blood samples were collected to analyze the chemistry parameters: amylase and lipase.

95. Period 1: Absolute Values for Urinalysis Parameter: Specific Gravity [Day 9]

    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.

96. Period 2: Absolute Values for Urinalysis Parameter: Specific Gravity [Day 7]

    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.

97. Period 3: Absolute Values for Urinalysis Parameter: Specific Gravity [Days 4, 7 and 10]

    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.

98. Period 1: Absolute Values for Urinalysis Parameter: Urobilinogen [Day 9]

    Urine samples were collected to analyze the urinalysis parameter: urobilinogen.

99. Period 2: Absolute Values for Urinalysis Parameter: Urobilinogen [Day 7]

    Urine samples were collected to analyze the urinalysis parameter: urobilinogen.

100. Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen [Days 4, 7 and 10]

     Urine samples were collected to analyze the urinalysis parameter: urobilinogen.

101. Period 1: Absolute Values for Urinalysis Parameter: pH [Day 9]

     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 acid pH (5.0 - 6.0).

102. Period 2: Absolute Values for Urinalysis Parameter: pH [Day 7]

     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 acid pH (5.0 - 6.0).

103. Period 3: Absolute Values for Urinalysis Parameter: pH [Days 4, 7 and 10]

     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 acid pH (5.0 - 6.0).

104. Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB [Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours]

     Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.

105. Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB [Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours]

     Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.

106. Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB [Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10]

     Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.

107. Period 1: Absolute Values for SBP and DBP [Days 2, 3, 4 and 5]

     SBP and DBP were measured in the semi-recumbent position with a completely automated device.

108. Period 2: Absolute Values for SBP and DBP [Days 2, 3, 4, 5, 6 and 7]

     SBP and DBP were measured in the semi-recumbent position with a completely automated device.

109. Period 3: Absolute Values for SBP and DBP [Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11]

     SBP and DBP were measured in the semi-recumbent position with a completely automated device.

110. Period 1: Absolute Values for Pulse Rate [Days 2, 3, 4 and 5]

     Pulse rate was measured in the semi-recumbent position with a completely automated device.

111. Period 2: Absolute Values for Pulse Rate [Days 2, 3, 4, 5, 6 and 7]

     Pulse rate was measured in the semi-recumbent position with a completely automated device.

112. Period 3: Absolute Values for Pulse Rate [Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11]

     Pulse rate was measured in the semi-recumbent position with a completely automated device.

113. Period 1: Absolute Values for Respiratory Rate [Days 2, 3, 4 and 5]

     Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

114. Period 2: Absolute Values for Respiratory Rate [Days 2, 3, 4, 5, 6 and 7]

     Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

115. Period 3: Absolute Values for Respiratory Rate [Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11]

     Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

116. Period 1: Absolute Values for Body Temperature [Days 2, 3, 4 and 5]

     Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

117. Period 2: Absolute Values for Body Temperature [Days 2, 3, 4, 5, 6 and 7]

     Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

118. Period 3: Absolute Values for Body Temperature [Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11]

     Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.

119. Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 for GSK3640254 Arm [Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

120. Period 3: Tmax of GSK3640254 for Dolutegravir + GSK3640254 Arm [Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

121. Period 2: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 for GSK3640254 Arm [Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

     Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Data could not be determined due to limited sampling points after final dosing (during elimination phase). An accurate determination of GSK3640254 half-life would require sampling up to 3 times half-life (3 * approximately 24 hours). However sampling in Period 2 was performed up to only 24 hours post-dose.

122. Period 3: T1/2 of GSK3640254 for Dolutegravir + GSK3640254 Arm [Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

123. Period 1: Tmax of Dolutegravir for Dolutegravir Arm [Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

124. Period 3: Tmax of Dolutegravir for Dolutegravir + GSK3640254 Arm [Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

125. Period 1: T1/2 of Dolutegravir for Dolutegravir Arm [Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

126. Period 3: T1/2 of Dolutegravir for Dolutegravir + GSK3640254 Arm [Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent.

• Subjects who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).

• Body weight >=50 kilograms (kg) (110 pounds [lbs]) for men and >=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 31.0 kilograms per square meter (kg/m^2) (inclusive).

• Male or female subjects can participate. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP).

• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.

Exclusion Criteria:

• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

• A pre-existing condition interfering with normal gastrointestinal (GI) anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs or render the subject unable to take oral study intervention.

• Any history of significant underlying psychiatric disorder, including but not limited to schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder.

• Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment. Subjects with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the ViiV Medical Monitor.

• Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the investigator (with or without psychiatric evaluation), could interfere with the subject's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the subject.

• Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome.

• Presence of Hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to starting study intervention.

• Positive Hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention and positive on reflex to Hepatitis C ribonucleic acid (RNA).

• Positive HIV-1 and -2 antigen/antibody immunoassay at Screening.

• ALT >1.5 times upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility.

• Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).

• Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.

• Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT (described above), will exclude a subject from the study unless the investigator can provide a compelling explanation for the laboratory results and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility.

• A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine (indicating active current smoking) at Screening or before the first dose of study intervention.

• Unable to refrain from the use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication and for the duration of the study.

• Treatment with any vaccine within 30 days prior to receiving study intervention.

• Unwillingness to abstain from excessive consumption of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study intervention(s) until the end of the study.

• Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the study intervention (whichever is longer).

• Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 56 days.

• Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia Suicide Severity Rating Scale (C-SSRS).

• Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction, sinoatrial pauses, bundle branch block, or conduction abnormality) which, in the opinion of the investigator or ViiV Healthcare (VH)/GlaxoSmithKline (GSK) Medical Monitor, will interfere with the safety for the individual subject.

• Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): Heart rate (males: <45 or >100 beats per minute [bpm] and females: <50 or >100 bpm); PR interval (<120 or >200 milliseconds [msec]); QRS duration (<70 or

110 msec); QTcF interval (males: >450 msec and females: >470 msec).

• History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 units. One unit is equivalent to 8 grams of alcohol: a half-pint (equivalent to 240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits.

• Regular use of tobacco- or nicotine-containing products within 3 months prior to Screening.

• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Austin	Texas	United States	78744

Sponsors and Collaborators

• ViiV Healthcare

Investigators

• Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

• Study Protocol - Dec 12, 2018
• Statistical Analysis Plan - Apr 1, 2019

More Information

Publications

None provided.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT03816696
• Other Study ID Numbers: 209712
• First Posted: Jan 25, 2019
• Last Update Posted: Mar 19, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ViiV Healthcare: GSK3640254, dolutegravir, healthy subjects, two-way interaction, HIV
• Additional relevant MeSH terms: HIV Infections

Study Results

Participant Flow

Recruitment Details	This was an open-label, fixed-sequence, two-way drug interaction and 3-period study. Participants received treatment A- dolutegravir 50 milligram (mg) in Period 1; treatment B- GSK3640254 200 mg in Period 2 and treatment C- dolutegravir 50 mg and GSK3640254 200 mg in Period 3.
Pre-assignment Detail	A total of 30 participants were screened, of which 14 were screening failures. Hence, 16 participants were enrolled in this study. This study was conducted at a single center in the United States.

Arm/Group Title	Dolutegravir/GSK3640254/Dolutegravir+GSK3640254
Arm/Group Description	Participants received treatment A- dolutegravir 50 mg, tablets, orally, once daily on Days 1 to 5 in Period 1; followed by washout period of 4 days between last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2; followed by treatment B- GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 2; further followed by treatment C- dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 3.
Period Title: Period 1 (Up to Day 5)
STARTED	16
COMPLETED	16
NOT COMPLETED	0
Period Title: Period 1 (Up to Day 5)
STARTED	16
COMPLETED	16
NOT COMPLETED	0
Period Title: Period 1 (Up to Day 5)
STARTED	16
COMPLETED	16
NOT COMPLETED	0
Period Title: Period 1 (Up to Day 5)
STARTED	16
COMPLETED	16
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Dolutegravir/GSK3640254/Dolutegravir+GSK3640254
Arm/Group Description	Participants received treatment A- dolutegravir 50 mg, tablets, orally, once daily on Days 1 to 5 in Period 1; followed by washout period of 4 days between last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2; followed by treatment B- GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 2; further followed by treatment C- dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 3.
Overall Participants	16
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	36.7 (10.66)
Sex: Female, Male (Count of Participants)
Female	1 6.3%
Male	15 93.8%
Race/Ethnicity, Customized (Count of Participants)
Asian - East Asian Heritage	1 6.3%
Asian - South East Asian Heritage	1 6.3%
Black or African American	3 18.8%
White - White/Caucasian/European Heritage	11 68.8%

Outcome Measures

1. Primary Outcome

Title	Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing (AUC[0 to Tau]) of Dolutegravir for Dolutegravir Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic Parameter Population consisted of all participants who underwent plasma pharmacokinetic sampling and had evaluable pharmacokinetic parameters estimated.
Time Frame	Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Hours* nanogram per milliliter]	64627.8 (20.1)

2. Primary Outcome

Title	Period 3: AUC(0 to Tau) of Dolutegravir for Dolutegravir + GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Hours* nanogram per milliliter]	75860.5 (22.7)

3. Primary Outcome

Title	Period 1: Maximum Observed Concentration (Cmax) of Dolutegravir for Dolutegravir Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	4962 (16.5)

4. Primary Outcome

Title	Period 3: Cmax of Dolutegravir for Dolutegravir + GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	5408 (17.2)

5. Primary Outcome

Title	Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of Dolutegravir for Dolutegravir Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	1373 (30.6)

6. Primary Outcome

Title	Period 3: Ctau of Dolutegravir for Dolutegravir + GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	1696 (31.1)

7. Primary Outcome

Title	Period 2: AUC(0 to Tau) of GSK3640254 for GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Hours* microgram per milliliter]	26.72 (32.3)

8. Primary Outcome

Title	Period 3: AUC(0 to Tau) of GSK3640254 for Dolutegravir + GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Hours* microgram per milliliter]	27.84 (30.1)

9. Primary Outcome

Title	Period 2: Cmax of GSK3640254 for GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter]	1.676 (26.4)

10. Primary Outcome

Title	Period 3: Cmax of GSK3640254 for Dolutegravir + GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter]	1.662 (26.8)

11. Primary Outcome

Title	Period 2: Ctau of GSK3640254 for GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter]	0.8583 (38.3)

12. Primary Outcome

Title	Period 3: Ctau of GSK3640254 for Dolutegravir + GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter]	0.8549 (34.1)

13. Secondary Outcome

Title	Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
Description	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; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication.
Time Frame	Up to Day 27

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg	GSK3640254 200 mg	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16	16	16
Non-SAEs	1 6.3%	3 NaN	2 NaN
SAEs	0 0%	0 NaN	0 NaN

14. Secondary Outcome

Title	Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Description	Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Basophils	-0.003 (0.0124)
Eosinophils	0.046 (0.1198)
Lymphocytes	0.013 (0.3793)
Monocytes	-0.020 (0.0829)
Neutrophils	-0.217 (0.6421)
Platelet count	-6.5 (21.73)

15. Secondary Outcome

Title	Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Description	Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Basophils	-0.006 (0.0089)
Eosinophils	-0.026 (0.0810)
Lymphocytes	-0.154 (0.2718)
Monocytes	-0.024 (0.0701)
Neutrophils	-0.160 (0.3762)
Platelet count	-6.0 (30.58)

16. Secondary Outcome

Title	Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Description	Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4: Basophils, n=16	0.003 (0.0101)
Day 7: Basophils, n=16	0.007 (0.0135)
Day 10: Basophils, n=16	0.003 (0.0144)
Day 4: Eosinophils, n=16	-0.001 (0.0448)
Day 7: Eosinophils, n=16	0.004 (0.0846)
Day 10: Eosinophils, n=16	-0.036 (0.0468)
Day 4: Lymphocytes, n=16	-0.130 (0.2931)
Day 7: Lymphocytes, n=16	-0.033 (0.3260)
Day 10: Lymphocytes, n=16	-0.117 (0.2628)
Day 4: Monocytes, n=16	0.049 (0.1627)
Day 7: Monocytes, n=16	0.003 (0.0850)
Day 10: Monocytes, n=16	-0.018 (0.0693)
Day 4: Neutrophils, n=16	0.443 (1.5098)
Day 7: Neutrophils, n=16	0.076 (0.5969)
Day 10: Neutrophils, n=16	0.204 (0.5116)
Day 4: Platelet count, n=16	-4.9 (11.08)
Day 7: Platelet count, n=15	-11.5 (12.03)
Day 10: Platelet count, n=16	-5.9 (16.50)

17. Secondary Outcome

Title	Period 1: Change From Baseline in Hematology Parameter: Hemoglobin
Description	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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Grams per liter]	4.4 (5.97)

18. Secondary Outcome

Title	Period 2: Change From Baseline in Hematology Parameter: Hemoglobin
Description	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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Grams per liter]	0.1 (2.53)

19. Secondary Outcome

Title	Period 3: Change From Baseline in Hematology Parameter: Hemoglobin
Description	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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	3.3 (3.00)
Day 7	0.6 (3.50)
Day 10	1.2 (3.69)

20. Secondary Outcome

Title	Period 1: Change From Baseline in Hematology Parameter: Hematocrit
Description	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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Proportion of red blood cells in blood]	0.0178 (0.01988)

21. Secondary Outcome

Title	Period 2: Change From Baseline in Hematology Parameter: Hematocrit
Description	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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Proportion of red blood cells in blood]	-0.0013 (0.00948)

22. Secondary Outcome

Title	Period 3: Change From Baseline in Hematology Parameter: Hematocrit
Description	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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	0.0035 (0.00794)
Day 7	-0.0049 (0.01101)
Day 10	-0.0041 (0.01402)

23. Secondary Outcome

Title	Period 1: Change From Baseline in Hematology Parameter: Erythrocytes
Description	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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Trillion cells per liter]	0.170 (0.2080)

24. Secondary Outcome

Title	Period 2: Change From Baseline in Hematology Parameter: Erythrocytes
Description	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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Trillion cells per liter]	0.036 (0.1020)

25. Secondary Outcome

Title	Period 3: Change From Baseline in Hematology Parameter: Erythrocytes
Description	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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	0.016 (0.0943)
Day 7	-0.079 (0.1038)
Day 10	-0.054 (0.1540)

26. Secondary Outcome

Title	Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Description	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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Femtoliter]	0.63 (0.774)

27. Secondary Outcome

Title	Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Description	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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Femtoliter]	-0.86 (0.564)

28. Secondary Outcome

Title	Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Description	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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	0.40 (0.542)
Day 7	0.36 (0.762)
Day 10	0.05 (0.954)

29. Secondary Outcome

Title	Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Description	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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Picograms]	-0.11 (0.279)

30. Secondary Outcome

Title	Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Description	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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Picograms]	-0.17 (0.218)

31. Secondary Outcome

Title	Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Description	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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	0.55 (0.225)
Day 7	0.55 (0.329)
Day 10	0.52 (0.315)

32. Secondary Outcome

Title	Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Description	Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Glucose	0.063 (0.4235)
Cholesterol	0.088 (0.6858)
Triglycerides	-0.084 (0.3983)
Anion gap	-1.2 (1.33)
Calcium	0.025 (0.0599)
Carbon dioxide	-0.1 (2.03)
Chloride	1.6 (2.63)
Phosphate	0.091 (0.1531)
Potassium	0.05 (0.356)
Sodium	0.3 (2.15)
Blood urea nitrogen	0.297 (0.9823)

33. Secondary Outcome

Title	Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Description	Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Glucose	-0.249 (0.1748)
Cholesterol	-0.269 (0.2363)
Triglycerides	0.087 (0.2374)
Anion gap	2.2 (1.52)
Calcium	0.014 (0.0245)
Carbon dioxide	-1.3 (1.53)
Chloride	-0.7 (1.78)
Phosphate	0.037 (0.0955)
Potassium	-0.03 (0.272)
Sodium	0.3 (1.74)
Blood urea nitrogen	-0.341 (0.3937)

34. Secondary Outcome

Title	Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Description	Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4: Glucose	0.062 (0.1638)
Day 7: Glucose	0.103 (0.1806)
Day 10: Glucose	-0.066 (0.2205)
Day 4: Cholesterol	0.096 (0.2400)
Day 7: Cholesterol	-0.008 (0.2693)
Day 10: Cholesterol	-0.030 (0.2366)
Day 4: Triglycerides	0.034 (0.2316)
Day 7: Triglycerides	-0.094 (0.2578)
Day 10: Triglycerides	0.095 (0.2178)
Day 4: Anion gap	-4.1 (1.24)
Day 7: Anion gap	0.1 (1.69)
Day 10: Anion gap	0.8 (1.65)
Day 4: Calcium	-0.003 (0.0416)
Day 7: Calcium	0.026 (0.0413)
Day 10: Calcium:	0.035 (0.0561)
Day 4: Carbon dioxide	0.9 (1.65)
Day 7: Carbon dioxide	0.1 (1.59)
Day 10: Carbon dioxide	1.0 (2.16)
Day 4: Chloride	0.7 (1.92)
Day 7: Chloride	-0.3 (1.39)
Day 10: Chloride	-1.1 (1.86)
Day 4: Phosphate	-0.004 (0.0808)
Day 7: Phosphate	-0.013 (0.1151)
Day 10: Phosphate	-0.051 (0.1115)
Day 4: Potassium	-0.04 (0.239)
Day 7: Potassium	-0.03 (0.218)
Day 10: Potassium	0.06 (0.189)
Day 4: Sodium	-2.0 (1.37)
Day 7: Sodium	-0.1 (1.65)
Day 10: Sodium	0.5 (1.90)
Day 4: Blood urea nitrogen	0.054 (0.5287)
Day 7: Blood urea nitrogen	-0.178 (0.3542)
Day 10: Blood urea nitrogen	-0.026 (0.5156)

35. Secondary Outcome

Title	Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
Description	Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Creatine kinase	-32.0 (61.33)
Lactate dehydrogenase	-21.9 (14.16)
ALT	-0.3 (8.28)
ALP	-0.1 (7.67)
AST	-0.7 (3.36)
Gamma-glutamyl transferase	-2.1 (3.13)

36. Secondary Outcome

Title	Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Description	Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Creatine kinase	22.6 (58.21)
Lactate dehydrogenase	9.1 (5.76)
ALT	-0.6 (2.80)
ALP	1.9 (2.70)
AST	0.2 (1.87)
Gamma-glutamyl transferase	-0.8 (1.28)

37. Secondary Outcome

Title	Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Description	Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4: Creatine kinase	-32.1 (131.30)
Day 7: Creatine kinase	-37.1 (158.35)
Day 10: Creatine kinase	-42.1 (162.94)
Day 4: Lactate dehydrogenase	5.9 (7.38)
Day 7: Lactate dehydrogenase	-0.9 (7.02)
Day 10: Lactate dehydrogenase	0.1 (10.32)
Day 4: ALT	1.1 (4.36)
Day 7: ALT	0.7 (4.69)
Day 10: ALT	1.9 (4.11)
Day 4: ALP	-1.6 (2.00)
Day 7: ALP	-0.6 (2.39)
Day 10: ALP	0.8 (4.06)
Day 4: AST	0.9 (2.45)
Day 7: AST	-0.5 (2.68)
Day 10: AST	0.3 (2.29)
Day 4: Gamma-glutamyl transferase	-0.8 (0.75)
Day 7: Gamma-glutamyl transferase	-0.3 (1.06)
Day 10: Gamma-glutamyl transferase	0.5 (1.51)

38. Secondary Outcome

Title	Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Description	Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Urate	-32.3 (42.01)
Creatinine	5.41 (7.253)
Bilirubin	0.01 (4.516)
Direct bilirubin	0.03 (0.677)

39. Secondary Outcome

Title	Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Description	Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Urate	-7.1 (14.52)
Creatinine	-3.36 (4.219)
Bilirubin	0.27 (1.299)
Direct bilirubin	0.06 (0.328)

40. Secondary Outcome

Title	Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Description	Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4: Urate	0.0 (16.23)
Day 7: Urate	-15.6 (26.39)
Day 10: Urate	-1.4 (24.69)
Day 4: Creatinine	7.90 (4.239)
Day 7: Creatinine	9.89 (4.014)
Day 10: Creatinine	1.99 (4.739)
Day 4: Bilirubin	2.24 (2.659)
Day 7: Bilirubin	-0.21 (1.455)
Day 10: Bilirubin	1.43 (2.011)
Day 4: Direct bilirubin	0.33 (0.425)
Day 7: Direct bilirubin	-0.19 (0.436)
Day 10: Direct bilirubin	0.22 (0.248)

41. Secondary Outcome

Title	Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Description	Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Albumin	0.4 (2.45)
Globulin	0.8 (1.11)
Protein	1.2 (3.06)

42. Secondary Outcome

Title	Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Description	Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Albumin	0.9 (1.45)
Globulin	-1.1 (0.77)
Protein	-0.2 (1.76)

43. Secondary Outcome

Title	Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
Description	Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4: Albumin	0.9 (1.00)
Day 7: Albumin	0.2 (1.22)
Day 10: Albumin	0.4 (2.06)
Day 4: Globulin	-0.9 (1.29)
Day 7: Globulin	1.0 (1.10)
Day 10: Globulin	0.5 (1.32)
Day 4: Protein	0.0 (1.75)
Day 7: Protein	1.2 (1.80)
Day 10: Protein	0.9 (2.90)

44. Secondary Outcome

Title	Period 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Description	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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Amylase	3.1 (9.63)
Lipase	-3.4 (8.97)

45. Secondary Outcome

Title	Period 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Description	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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Amylase	-2.8 (4.65)
Lipase	-0.7 (3.79)

46. Secondary Outcome

Title	Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Description	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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4: Amylase	-1.6 (3.18)
Day 7: Amylase	0.1 (4.25)
Day 10: Amylase	-0.9 (6.08)
Day 4: Lipase	4.7 (6.10)
Day 7: Lipase	-0.8 (4.76)
Day 10: Lipase	0.1 (5.24)

47. Secondary Outcome

Title	Period 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
Description	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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Ratio]	0.0053 (0.00865)

48. Secondary Outcome

Title	Period 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
Description	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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Ratio]	-0.0004 (0.00645)

49. Secondary Outcome

Title	Period 3: Change From Baseline in Urinalysis Parameter: Specific Gravity
Description	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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	0.0003 (0.00652)
Day 7	-0.0007 (0.00545)
Day 10	-0.0016 (0.00901)

50. Secondary Outcome

Title	Period 1: Change From Baseline in Urinalysis Parameter: Urobilinogen
Description	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, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Micromoles per liter]	0.0000 (0.00000)

51. Secondary Outcome

Title	Period 2: Change From Baseline in Urinalysis Parameter: Urobilinogen
Description	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, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Micromoles per liter]	0.0000 (0.00000)

52. Secondary Outcome

Title	Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen
Description	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, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	0.0000 (0.00000)
Day 7	0.0000 (0.00000)
Day 10	0.0000 (0.00000)

53. Secondary Outcome

Title	Period 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH)
Description	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 acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day -1) and at Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [pH]	-0.22 (0.730)

54. Secondary Outcome

Title	Period 2: Change From Baseline in Urinalysis Parameter: pH
Description	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 acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 1 Day 9) and at Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [pH]	0.13 (0.428)

55. Secondary Outcome

Title	Period 3: Change From Baseline in Urinalysis Parameter: pH
Description	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 acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Period 2 Day 7) and at Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	0.03 (0.531)
Day 7	-0.13 (0.500)
Day 10	0.16 (0.569)

56. Secondary Outcome

Title	Period 1: Number of Participants With Urinalysis Dipstick Results
Description	Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present) and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Bilirubin: Negative	16 100%
Glucose: Negative	16 100%
Ketones: Negative	15 93.8%
Ketones: Trace	1 6.3%
Leukocyte Esterase: Negative	16 100%
Nitrite: Negative	16 100%
Occult Blood: Negative	15 93.8%
Occult Blood: 2+	1 6.3%
Protein: Negative	16 100%

57. Secondary Outcome

Title	Period 2: Number of Participants With Urinalysis Dipstick Results
Description	Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Bilirubin: Negative	16 100%
Glucose: Negative	16 100%
Ketones: Negative	15 93.8%
Ketones: 1+	1 6.3%
Leukocyte Esterase: Negative	15 93.8%
Leukocyte Esterase: 1+	1 6.3%
Nitrite: Negative	16 100%
Occult Blood: Negative	16 100%
Protein: Negative	16 100%

58. Secondary Outcome

Title	Period 3: Number of Participants With Urinalysis Dipstick Results
Description	Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present)indicating proportional concentrations in the urine sample.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Bilirubin: Day 4, Negative	16 100%
Bilirubin: Day 7, Negative	16 100%
Bilirubin: Day 10, Negative	16 100%
Glucose: Day 4, Negative	16 100%
Glucose: Day 7, Negative	16 100%
Glucose: Day 10, Negative	16 100%
Ketones: Day 4, Negative	16 100%
Ketones: Day 7, Negative	16 100%
Ketones: Day 10, Negative	16 100%
Leukocyte Esterase: Day 4, Negative	16 100%
Leukocyte Esterase: Day 7, Negative	16 100%
Leukocyte Esterase: Day 10, Negative	16 100%
Nitrite: Day 4, Negative	16 100%
Nitrite: Day 7, Negative	16 100%
Nitrite: Day 10, Negative	16 100%
Occult Blood: Day 4, Negative	16 100%
Occult Blood: Day 7, Negative	16 100%
Occult Blood: Day 10, Negative	16 100%
Protein: Day 4, Negative	16 100%
Protein: Day 7, Negative	16 100%
Protein: Day 10, Negative	16 100%

59. Secondary Outcome

Title	Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
Description	Twelve-lead electrocardiograms (ECG) were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline, Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
PR Interval: Day 1, 2 hours	-0.5 (9.33)
PR Interval: Day 1, 4 hours	1.7 (8.34)
PR Interval: Day 5, Pre-dose	4.7 (6.32)
PR Interval: Day 5, 2 hours	1.3 (8.52)
PR Interval: Day 5, 4 hours	1.9 (12.94)
QRS Duration: Day 1, 2 hours	1.8 (3.04)
QRS Duration: Day 1, 4 hours	1.3 (3.32)
QRS Duration: Day 5, Pre-dose	-0.8 (3.21)
QRS Duration: Day 5, 2 hours	0.8 (3.99)
QRS Duration: Day 5, 4 hours	0.6 (2.78)
QT Interval: Day 1, 2 hours	-5.5 (8.21)
QT Interval: Day 1, 4 hours	9.9 (12.91)
QT Interval: Day 5, Pre-dose	-6.8 (11.74)
QT Interval: Day 5, 2 hours	-16.3 (16.64)
QT Interval: Day 5, 4 hours	1.2 (16.07)
QTcF Interval: Day 1, 2 hours	-5.0 (8.42)
QTcF Interval: Day 1, 4 hours	-1.6 (8.52)
QTcF Interval: Day 5, Pre-dose	-7.1 (8.53)
QTcF Interval: Day 5, 2 hours	-7.9 (9.92)
QTcF Interval: Day 5, 4 hours	-3.9 (7.56)
QTcB Interval: Day 1, 2 hours	-4.5 (10.26)
QTcB Interval: Day 1, 4 hours	-7.4 (9.16)
QTcB Interval: Day 5, Pre-dose	-6.7 (8.16)
QTcB Interval: Day 5, 2 hours	-3.4 (10.84)
QTcB Interval: Day 5, 4 hours	-5.9 (11.62)

60. Secondary Outcome

Title	Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
Description	Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline; Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
PR Interval: Day 1, 2 hours	-3.3 (6.31)
PR Interval: Day 1, 4 hours	-3.0 (5.55)
PR Interval: Day 5, Pre-dose	-2.1 (6.15)
PR Interval: Day 5, 2 hours	-3.4 (7.81)
PR Interval: Day 5, 4 hours	-6.4 (6.77)
QRS Duration: Day 1, 2 hours	0.1 (2.54)
QRS Duration: Day 1, 4 hours	-1.1 (4.08)
QRS Duration: Day 5, Pre-dose	0.3 (3.89)
QRS Duration: Day 5, 2 hours	-0.2 (3.85)
QRS Duration: Day 5, 4 hours	0.6 (2.70)
QT Interval: Day 1, 2 hours	-7.9 (11.47)
QT Interval: Day 1, 4 hours	4.6 (13.48)
QT Interval: Day 5, Pre-dose	2.8 (17.38)
QT Interval: Day 5, 2 hours	-7.1 (16.13)
QT Interval: Day 5, 4 hours	6.3 (20.51)
QTcF Interval: Day 1, 2 hours	-1.3 (8.74)
QTcF Interval: Day 1, 4 hours	3.1 (6.44)
QTcF Interval: Day 5, Pre-dose	6.6 (6.79)
QTcF Interval: Day 5, 2 hours	3.7 (9.36)
QTcF Interval: Day 5, 4 hours	10.2 (10.44)
QTcB Interval: Day 1, 2 hours	2.4 (13.45)
QTcB Interval: Day 1, 4 hours	2.6 (12.62)
QTcB Interval: Day 5, Pre-dose	8.4 (5.92)
QTcB Interval: Day 5, 2 hours	9.9 (11.93)
QTcB Interval: Day 5, 4 hours	12.4 (8.57)

61. Secondary Outcome

Title	Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
Description	Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline; Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
PR Interval: Day 1, 2 hours	1.9 (7.47)
PR Interval: Day 1, 4 hours	-1.9 (8.19)
PR Interval: Day 4, Pre-dose	-0.4 (6.97)
PR Interval: Day 4, 2 hours	0.9 (8.48)
PR Interval: Day 4, 4 hours	-2.9 (9.53)
PR Interval: Day 5, Pre-dose	-1.4 (10.59)
PR Interval: Day 5, 2 hours	-3.2 (9.13)
PR Interval: Day 5, 4 hours	-2.7 (7.77)
PR Interval: Day 7, Pre-dose	3.6 (7.61)
PR Interval: Day 7, 2 hours	-1.0 (9.47)
PR Interval: Day 7, 4 hours	-0.4 (7.61)
PR Interval: Day 10	2.3 (8.60)
QRS Duration: Day 1, 2 hours	1.1 (5.47)
QRS Duration: Day 1, 4 hours	-2.1 (3.80)
QRS Duration: Day 4, Pre-dose	2.0 (5.61)
QRS Duration: Day 4, 2 hours	-1.3 (3.09)
QRS Duration: Day 4, 4 hours	0.5 (6.63)
QRS Duration: Day 5, Pre-dose	1.8 (6.18)
QRS Duration: Day 5, 2 hours	1.3 (5.11)
QRS Duration: Day 5, 4 hours	-0.5 (3.31)
QRS Duration: Day 7, Pre-dose	0.6 (3.58)
QRS Duration: Day 7, 2 hours	0.3 (4.93)
QRS Duration: Day 7, 4 hours	-0.4 (3.72)
QRS Duration: Day 10	1.7 (5.45)
QT Interval: Day 1, 2 hours	-7.8 (8.68)
QT Interval: Day 1, 4 hours	4.4 (13.15)
QT Interval: Day 4, Pre-dose	1.4 (14.28)
QT Interval: Day 4, 2 hours	-11.2 (14.53)
QT Interval: Day 4, 4 hours	7.4 (13.68)
QT Interval: Day 5, Pre-dose	-1.4 (13.57)
QT Interval: Day 5, 2 hours	-6.9 (10.65)
QT Interval: Day 5, 4 hours	3.9 (14.59)
QT Interval: Day 7, Pre-dose	3.2 (17.34)
QT Interval: Day 7, 2 hours	-5.6 (14.01)
QT Interval: Day 7, 4 hours	8.0 (15.38)
QT Interval: Day 10	5.1 (10.39)
QTcF Interval: Day 1, 2 hours	-0.4 (5.63)
QTcF Interval: Day 1, 4 hours	6.6 (4.97)
QTcF Interval: Day 4, Pre-dose	2.7 (8.21)
QTcF Interval: Day 4, 2 hours	-2.5 (8.41)
QTcF Interval: Day 4, 4 hours	8.1 (9.10)
QTcF Interval: Day 5, Pre-dose	6.1 (8.14)
QTcF Interval: Day 5, 2 hours	1.1 (9.42)
QTcF Interval: Day 5, 4 hours	8.6 (6.26)
QTcF Interval: Day 7, Pre-dose	2.0 (9.21)
QTcF Interval: Day 7, 2 hours	0.6 (7.46)
QTcF Interval: Day 7, 4 hours	3.6 (7.28)
QTcF Interval: Day 10	1.6 (7.36)
QTcB Interval: Day 1, 2 hours	3.8 (9.50)
QTcB Interval: Day 1, 4 hours	7.4 (10.78)
QTcB Interval: Day 4, Pre-dose	3.8 (13.72)
QTcB Interval: Day 4, 2 hours	-0.6 (17.78)
QTcB Interval: Day 4, 4 hours	8.6 (12.83)
QTcB Interval: Day 5, Pre-dose	10.6 (13.25)
QTcB Interval: Day 5, 2 hours	5.5 (12.47)
QTcB Interval: Day 5, 4 hours	11.3 (9.50)
QTcB Interval: Day 7, Pre-dose	2.1 (14.09)
QTcB Interval: Day 7, 2 hours	4.4 (14.43)
QTcB Interval: Day 7, 4 hours	1.4 (10.35)
QTcB Interval: Day 10	0.2 (10.89)

62. Secondary Outcome

Title	Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Description	SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
SBP: Day 2	3.5 (9.97)
SBP: Day 3	-0.4 (8.88)
SBP: Day 4	3.7 (11.97)
SBP: Day 5	-6.2 (8.88)
DBP: Day 2	4.3 (6.70)
DBP: Day 3	0.9 (9.89)
DBP: Day 4	2.3 (8.50)
DBP: Day 5	-2.6 (10.70)

63. Secondary Outcome

Title	Period 2: Change From Baseline in SBP and DBP
Description	SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
SBP: Day 2	1.7 (5.19)
SBP: Day 3	1.3 (6.83)
SBP: Day 4	3.0 (7.73)
SBP: Day 5	-0.5 (5.40)
SBP: Day 6	-0.1 (8.01)
SBP: Day 7	0.6 (4.57)
DBP: Day 2	-0.4 (7.03)
DBP: Day 3	1.1 (4.46)
DBP: Day 4	-0.4 (4.67)
DBP: Day 5	-1.3 (4.85)
DBP: Day 6	0.3 (6.37)
DBP: Day 7	0.4 (5.62)

64. Secondary Outcome

Title	Period 3: Change From Baseline in SBP and DBP
Description	SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
SBP: Day 2	-0.1 (7.66)
SBP: Day 3	-3.4 (6.54)
SBP: Day 4	-3.3 (6.63)
SBP: Day 5	3.6 (17.17)
SBP: Day 6	-1.4 (7.08)
SBP: Day 7	-2.1 (7.76)
SBP: Day 8	-2.0 (9.36)
SBP: Day 9	-2.3 (8.00)
SBP: Day 10	-4.3 (8.35)
SBP: Day 11	-3.4 (7.69)
DBP: Day 2	1.3 (3.32)
DBP: Day 3	-0.1 (5.73)
DBP: Day 4	1.2 (4.51)
DBP: Day 5	6.7 (22.20)
DBP: Day 6	1.4 (6.99)
DBP: Day 7	2.9 (5.88)
DBP: Day 8	1.8 (9.89)
DBP: Day 9	2.1 (5.87)
DBP: Day 10	2.3 (4.91)
DBP: Day 11	-0.1 (5.43)

65. Secondary Outcome

Title	Period 1: Change From Baseline in Pulse Rate
Description	Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Day 2	-0.3 (4.30)
Day 3	-1.3 (4.63)
Day 4	2.0 (8.46)
Day 5	-1.6 (5.08)

66. Secondary Outcome

Title	Period 2: Change From Baseline in Pulse Rate
Description	Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Day 2	3.9 (8.54)
Day 3	5.4 (7.19)
Day 4	4.8 (7.50)
Day 5	4.2 (8.73)
Day 6	3.8 (6.51)
Day 7	2.7 (5.78)

67. Secondary Outcome

Title	Period 3: Change From Baseline in Pulse Rate
Description	Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 2	1.8 (5.65)
Day 3	2.2 (6.88)
Day 4	0.3 (7.63)
Day 5	3.1 (7.79)
Day 6	1.3 (6.97)
Day 7	-2.1 (5.94)
Day 8	2.3 (9.34)
Day 9	-0.8 (7.90)
Day 10	-2.9 (5.34)
Day 11	1.7 (10.56)

68. Secondary Outcome

Title	Period 1: Change From Baseline in Respiratory Rate
Description	Respiratory rate was measured in the semi-recumbent position 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, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Day 2	-0.9 (3.18)
Day 3	0.3 (2.05)
Day 4	-1.5 (3.06)
Day 5	-0.8 (2.29)

69. Secondary Outcome

Title	Period 2: Change From Baseline in Respiratory Rate
Description	Respiratory rate was measured in the semi-recumbent position 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, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Day 2, n=16	-0.5 (2.58)
Day 3, n=16	0.4 (3.03)
Day 4, n=16	-0.6 (3.07)
Day 5, n=15	1.3 (2.47)
Day 6, n=16	-0.4 (2.55)
Day 7, n=16	0.1 (3.30)

70. Secondary Outcome

Title	Period 3: Change From Baseline in Respiratory Rate
Description	Respiratory rate was measured in the semi-recumbent position 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, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 2	1.4 (3.07)
Day 3	0.5 (3.39)
Day 4	0.3 (3.34)
Day 5	-0.5 (2.97)
Day 6	0.6 (3.24)
Day 7	0.3 (3.09)
Day 8	1.4 (2.80)
Day 9	-0.4 (3.36)
Day 10	1.4 (2.80)
Day 11	2.8 (2.41)

71. Secondary Outcome

Title	Period 1: Change From Baseline in Body Temperature
Description	Body temperature was measured in the semi-recumbent position 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, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Day 2	-0.04 (0.326)
Day 3	-0.14 (0.287)
Day 4	-0.19 (0.370)
Day 5	0.03 (0.275)

72. Secondary Outcome

Title	Period 2: Change From Baseline in Body Temperature
Description	Body temperature was measured in the semi-recumbent position 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, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Day 2	-0.14 (0.299)
Day 3	-0.25 (0.415)
Day 4	-0.19 (0.294)
Day 5	-0.05 (0.363)
Day 6	-0.13 (0.300)
Day 7	-0.13 (0.373)

73. Secondary Outcome

Title	Period 3: Change From Baseline in Body Temperature
Description	Body temperature was measured in the semi-recumbent position 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, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time Frame	Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 2	-0.08 (0.286)
Day 3	-0.18 (0.423)
Day 4	0.02 (0.229)
Day 5	0.00 (0.175)
Day 6	-0.03 (0.318)
Day 7	0.06 (0.287)
Day 8	-0.13 (0.458)
Day 9	-0.10 (0.329)
Day 10	-0.03 (0.291)
Day 11	0.13 (0.302)

74. Secondary Outcome

Title	Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Description	Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Basophils	0.045 (0.0115)
Eosinophils	0.232 (0.1440)
Lymphocytes	2.023 (0.5931)
Monocytes	0.512 (0.1133)
Neutrophils	3.038 (0.7559)
Platelet count	270.2 (47.62)

75. Secondary Outcome

Title	Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Description	Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Basophils	0.039 (0.0134)
Eosinophils	0.206 (0.0960)
Lymphocytes	1.869 (0.4383)
Monocytes	0.488 (0.1081)
Neutrophils	2.878 (0.6859)
Platelet count	264.2 (48.37)

76. Secondary Outcome

Title	Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
Description	Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4: Basophils, n=16	0.043 (0.0165)
Day 7: Basophils, n=16	0.046 (0.0196)
Day 10: Basophils, n=16	0.042 (0.0142)
Day 4: Eosinophils, n=16	0.206 (0.1120)
Day 7: Eosinophils, n=16	0.211 (0.1512)
Day 10: Eosinophils, n=16	0.171 (0.0874)
Day 4: Lymphocytes, n=16	1.739 (0.3701)
Day 7: Lymphocytes, n=16	1.837 (0.3916)
Day 10: Lymphocytes, n=16	1.753 (0.3450)
Day 4: Monocytes, n=16	0.537 (0.1821)
Day 7: Monocytes, n=16	0.490 (0.1157)
Day 10: Monocytes, n=16	0.470 (0.1128)
Day 4: Neutrophils, n=16	3.321 (1.4579)
Day 7: Neutrophils, n=16	2.954 (0.5600)
Day 10: Neutrophils, n=16	3.082 (0.6649)
Day 4: Platelet count, n=16	259.3 (46.03)
Day 7: Platelet count, n=15	255.3 (46.20)
Day 10: Platelet count, n=16	258.3 (42.92)

77. Secondary Outcome

Title	Period 1: Absolute Values for Hematology Parameter: Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: hemoglobin.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Grams per liter]	146.4 (8.02)

78. Secondary Outcome

Title	Period 2: Absolute Values for Hematology Parameter: Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: hemoglobin.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Grams per liter]	146.5 (8.68)

79. Secondary Outcome

Title	Period 3: Absolute Values for Hematology Parameter: Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: hemoglobin.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	149.8 (8.74)
Day 7	147.1 (8.23)
Day 10	147.7 (9.17)

80. Secondary Outcome

Title	Period 1: Absolute Values for Hematology Parameter: Hematocrit
Description	Blood samples were collected to analyze the hematology parameter: hematocrit.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Proportion of red blood cells in blood]	0.4419 (0.01697)

81. Secondary Outcome

Title	Period 2: Absolute Values for Hematology Parameter: Hematocrit
Description	Blood samples were collected to analyze the hematology parameter: hematocrit.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Proportion of red blood cells in blood]	0.4406 (0.01887)

82. Secondary Outcome

Title	Period 3: Absolute Values for Hematology Parameter: Hematocrit
Description	Blood samples were collected to analyze the hematology parameter: hematocrit.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	0.4441 (0.01956)
Day 7	0.4357 (0.01924)
Day 10	0.4364 (0.02267)

83. Secondary Outcome

Title	Period 1: Absolute Values for Hematology Parameter: Erythrocytes
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Trillion cells per liter]	5.143 (0.3580)

84. Secondary Outcome

Title	Period 2: Absolute Values for Hematology Parameter: Erythrocytes
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Trillion cells per liter]	5.179 (0.3575)

85. Secondary Outcome

Title	Period 3: Absolute Values for Hematology Parameter: Erythrocytes
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	5.194 (0.3476)
Day 7	5.099 (0.3798)
Day 10	5.124 (0.3678)

86. Secondary Outcome

Title	Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Femtoliter]	86.22 (5.670)

87. Secondary Outcome

Title	Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Femtoliter]	85.36 (5.509)

88. Secondary Outcome

Title	Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	85.76 (5.323)
Day 7	85.72 (5.117)
Day 10	85.41 (5.030)

89. Secondary Outcome

Title	Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Picograms]	28.58 (2.446)

90. Secondary Outcome

Title	Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Picograms]	28.41 (2.385)

91. Secondary Outcome

Title	Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Description	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	28.96 (2.514)
Day 7	28.96 (2.404)
Day 10	28.93 (2.530)

92. Secondary Outcome

Title	Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Description	Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Glucose	5.165 (0.4788)
Cholesterol	4.456 (0.6591)
Triglycerides	1.107 (0.5362)
Anion gap	9.2 (1.28)
Calcium	2.393 (0.0781)
Carbon dioxide	30.5 (1.15)
Chloride	103.8 (2.32)
Phosphate	1.244 (0.1658)
Potassium	4.31 (0.427)
Sodium	139.3 (2.52)
Blood urea nitrogen	5.406 (0.7575)

93. Secondary Outcome

Title	Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Description	Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Glucose	4.916 (0.4825)
Cholesterol	4.187 (0.6783)
Triglycerides	1.194 (0.7294)
Anion gap	11.4 (1.20)
Calcium	2.406 (0.0772)
Carbon dioxide	29.3 (1.57)
Chloride	103.1 (2.35)
Phosphate	1.281 (0.1510)
Potassium	4.23 (0.249)
Sodium	139.6 (1.90)
Blood urea nitrogen	5.065 (0.6775)

94. Secondary Outcome

Title	Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Description	Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4: Glucose	4.978 (0.4655)
Day 7: Glucose	5.018 (0.3977)
Day 10: Glucose	4.849 (0.3858)
Day 4: Cholesterol	4.283 (0.8001)
Day 7: Cholesterol	4.179 (0.7438)
Day 10: Cholesterol	4.157 (0.8037)
Day 4: Triglycerides	1.228 (0.6403)
Day 7: Triglycerides	1.100 (0.5887)
Day 10: Triglycerides	1.289 (0.6625)
Day 4: Anion gap	7.3 (1.01)
Day 7: Anion gap	11.4 (1.75)
Day 10: Anion gap	12.1 (1.31)
Day 4: Calcium	2.404 (0.0855)
Day 7: Calcium	2.433 (0.0827)
Day 10: Calcium	2.441 (0.0681)
Day 4: Carbon dioxide	30.2 (1.56)
Day 7: Carbon dioxide	29.4 (1.15)
Day 10: Carbon dioxide	30.3 (1.53)
Day 4: Chloride	103.8 (2.77)
Day 7: Chloride	102.8 (2.07)
Day 10: Chloride	101.9 (2.02)
Day 4: Phosphate	1.276 (0.1304)
Day 7: Phosphate	1.268 (0.1802)
Day 10: Phosphate	1.229 (0.1213)
Day 4: Potassium	4.19 (0.150)
Day 7: Potassium	4.19 (0.217)
Day 10: Potassium	4.29 (0.275)
Day 4: Sodium	137.6 (2.06)
Day 7: Sodium	139.5 (2.56)
Day 10: Sodium	140.1 (2.11)
Day 4: Blood urea nitrogen	5.119 (0.8548)
Day 7: Blood urea nitrogen	4.887 (0.6388)
Day 10: Blood urea nitrogen	5.039 (0.8264)

95. Secondary Outcome

Title	Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Description	Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Creatine kinase	101.3 (57.10)
Lactate dehydrogenase	107.4 (14.33)
ALT	21.0 (10.71)
ALP	57.4 (8.74)
AST	16.6 (3.86)
Gamma-glutamyl transferase	21.1 (9.24)

96. Secondary Outcome

Title	Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Description	Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Creatine kinase	123.9 (112.28)
Lactate dehydrogenase	116.5 (15.10)
ALT	20.4 (9.88)
ALP	59.3 (9.19)
AST	16.8 (3.80)
Gamma-glutamyl transferase	20.3 (8.44)

97. Secondary Outcome

Title	Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
Description	Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4: Creatine kinase	110.3 (67.02)
Day 7: Creatine kinase	105.3 (63.83)
Day 10: Creatine kinase	100.3 (50.51)
Day 4: Lactate dehydrogenase	122.4 (16.26)
Day 7: Lactate dehydrogenase	115.6 (15.47)
Day 10: Lactate dehydrogenase	116.6 (18.79)
Day 4: ALT	21.4 (11.98)
Day 7: ALT	21.1 (12.00)
Day 10: ALT	22.3 (12.93)
Day 4: ALP	57.8 (9.34)
Day 7: ALP	58.8 (9.63)
Day 10: ALP	60.1 (9.07)
Day 4: AST	17.7 (5.12)
Day 7: AST	16.3 (4.78)
Day 10: AST	17.1 (4.55)
Day 4: Gamma-glutamyl transferase	19.5 (8.38)
Day 7: Gamma-glutamyl transferase	20.1 (8.35)
Day 10: Gamma-glutamyl transferase	20.8 (9.13)

98. Secondary Outcome

Title	Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Description	Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Urate	321.9 (64.43)
Creatinine	90.28 (11.281)
Bilirubin	9.14 (2.423)
Direct bilirubin	1.87 (0.551)

99. Secondary Outcome

Title	Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Description	Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Urate	314.8 (69.34)
Creatinine	86.92 (11.567)
Bilirubin	9.41 (3.014)
Direct bilirubin	1.93 (0.704)

100. Secondary Outcome

Title	Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
Description	Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4: Urate	314.8 (65.44)
Day 7: Urate	299.3 (62.85)
Day 10: Urate	313.4 (60.33)
Day 4: Creatinine	94.82 (13.650)
Day 7: Creatinine	96.81 (12.861)
Day 10: Creatinine	88.91 (12.545)
Day 4: Bilirubin	11.64 (4.856)
Day 7: Bilirubin	9.19 (2.511)
Day 10: Bilirubin	10.83 (3.796)
Day 4: Direct bilirubin	2.26 (0.995)
Day 7: Direct bilirubin	1.74 (0.617)
Day 10: Direct bilirubin	2.15 (0.784)

101. Secondary Outcome

Title	Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Description	Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Albumin	44.1 (3.32)
Globulin	27.9 (3.59)
Protein	71.9 (4.63)

102. Secondary Outcome

Title	Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Description	Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Albumin	44.9 (3.13)
Globulin	26.8 (3.78)
Protein	71.8 (4.73)

103. Secondary Outcome

Title	Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
Description	Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4: Albumin	45.9 (3.12)
Day 7: Albumin	45.1 (2.83)
Day 10: Albumin	45.3 (2.80)
Day 4: Globulin	25.9 (3.52)
Day 7: Globulin	27.8 (3.49)
Day 10: Globulin	27.3 (3.34)
Day 4: Protein	71.8 (3.89)
Day 7: Protein	72.9 (4.28)
Day 10: Protein	72.6 (4.11)

104. Secondary Outcome

Title	Period 1: Absolute Values for Chemistry Parameters: Amylase, Lipase
Description	Blood samples were collected to analyze the chemistry parameters: amylase and lipase.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Amylase	59.6 (21.96)
Lipase	22.4 (8.57)

105. Secondary Outcome

Title	Period 2: Absolute Values for Chemistry Parameters: Amylase, Lipase
Description	Blood samples were collected to analyze the chemistry parameters: amylase and lipase.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Amylase	56.8 (19.06)
Lipase	21.7 (7.34)

106. Secondary Outcome

Title	Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase
Description	Blood samples were collected to analyze the chemistry parameters: amylase and lipase.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4: Amylase	55.3 (18.81)
Day 7: Amylase	56.9 (21.03)
Day 10: Amylase	55.9 (20.57)
Day 4: Lipase	26.4 (11.10)
Day 7: Lipase	20.9 (9.12)
Day 10: Lipase	21.8 (9.25)

107. Secondary Outcome

Title	Period 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Description	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.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Ratio]	1.0181 (0.00662)

108. Secondary Outcome

Title	Period 2: Absolute Values for Urinalysis Parameter: Specific Gravity
Description	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.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Ratio]	1.0176 (0.00552)

109. Secondary Outcome

Title	Period 3: Absolute Values for Urinalysis Parameter: Specific Gravity
Description	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.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	1.0179 (0.00712)
Day 7	1.0169 (0.00640)
Day 10	1.0160 (0.00747)

110. Secondary Outcome

Title	Period 1: Absolute Values for Urinalysis Parameter: Urobilinogen
Description	Urine samples were collected to analyze the urinalysis parameter: urobilinogen.
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [Micromoles per liter]	3.3860 (0.00000)

111. Secondary Outcome

Title	Period 2: Absolute Values for Urinalysis Parameter: Urobilinogen
Description	Urine samples were collected to analyze the urinalysis parameter: urobilinogen.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [Micromoles per liter]	3.3860 (0.00000)

112. Secondary Outcome

Title	Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen
Description	Urine samples were collected to analyze the urinalysis parameter: urobilinogen.
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	3.3860 (0.00000)
Day 7	3.3860 (0.00000)
Day 10	3.3860 (0.00000)

113. Secondary Outcome

Title	Period 1: Absolute Values for Urinalysis Parameter: pH
Description	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 acid pH (5.0 - 6.0).
Time Frame	Day 9

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Mean (Standard Deviation) [pH]	5.88 (0.465)

114. Secondary Outcome

Title	Period 2: Absolute Values for Urinalysis Parameter: pH
Description	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 acid pH (5.0 - 6.0).
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Mean (Standard Deviation) [pH]	6.00 (0.548)

115. Secondary Outcome

Title	Period 3: Absolute Values for Urinalysis Parameter: pH
Description	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 acid pH (5.0 - 6.0).
Time Frame	Days 4, 7 and 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 4	6.03 (0.591)
Day 7	5.88 (0.387)
Day 10	6.16 (0.473)

116. Secondary Outcome

Title	Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
Description	Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.
Time Frame	Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
PR Interval: Day 1, 2 hours	159.1 (14.42)
PR Interval: Day 1, 4 hours	161.3 (16.51)
PR Interval: Day 5, Pre-dose	164.3 (14.87)
PR Interval: Day 5, 2 hours	160.9 (11.34)
PR Interval: Day 5, 4 hours	161.5 (12.66)
QRS Duration: Day 1, 2 hours	95.2 (9.59)
QRS Duration: Day 1, 4 hours	94.7 (10.90)
QRS Duration: Day 5, Pre-dose	92.6 (8.39)
QRS Duration: Day 5, 2 hours	94.2 (10.78)
QRS Duration: Day 5, 4 hours	94.0 (9.26)
QT Interval: Day 1, 2 hours	386.4 (16.06)
QT Interval: Day 1, 4 hours	401.8 (19.94)
QT Interval: Day 5, Pre-dose	385.1 (13.96)
QT Interval: Day 5, 2 hours	375.6 (11.46)
QT Interval: Day 5, 4 hours	393.1 (18.80)
QTcF Interval: Day 1, 2 hours	391.6 (11.37)
QTcF Interval: Day 1, 4 hours	395.0 (12.90)
QTcF Interval: Day 5, Pre-dose	389.5 (10.92)
QTcF Interval: Day 5, 2 hours	388.6 (14.47)
QTcF Interval: Day 5, 4 hours	392.7 (14.11)
QTcB Interval: Day 1, 2 hours	393.1 (15.31)
QTcB Interval: Day 1, 4 hours	390.2 (16.01)
QTcB Interval: Day 5, Pre-dose	390.9 (14.91)
QTcB Interval: Day 5, 2 hours	394.2 (21.59)
QTcB Interval: Day 5, 4 hours	391.7 (19.71)

117. Secondary Outcome

Title	Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
Description	Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.
Time Frame	Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
PR Interval: Day 1, 2 hours	165.1 (15.46)
PR Interval: Day 1, 4 hours	165.4 (14.32)
PR Interval: Day 5, Pre-dose	166.3 (16.89)
PR Interval: Day 5, 2 hours	165.0 (19.90)
PR Interval: Day 5, 4 hours	162.0 (13.64)
QRS Duration: Day 1, 2 hours	94.1 (9.66)
QRS Duration: Day 1, 4 hours	92.9 (9.20)
QRS Duration: Day 5, Pre-dose	94.3 (10.12)
QRS Duration: Day 5, 2 hours	93.9 (9.00)
QRS Duration: Day 5, 4 hours	94.7 (8.51)
QT Interval: Day 1, 2 hours	381.8 (14.37)
QT Interval: Day 1, 4 hours	394.4 (19.18)
QT Interval: Day 5, Pre-dose	392.6 (23.20)
QT Interval: Day 5, 2 hours	382.6 (17.13)
QT Interval: Day 5, 4 hours	396.0 (21.45)
QTcF Interval: Day 1, 2 hours	390.0 (13.74)
QTcF Interval: Day 1, 4 hours	394.4 (12.38)
QTcF Interval: Day 5, Pre-dose	397.9 (14.64)
QTcF Interval: Day 5, 2 hours	395.0 (14.70)
QTcF Interval: Day 5, 4 hours	401.5 (12.66)
QTcB Interval: Day 1, 2 hours	393.3 (18.57)
QTcB Interval: Day 1, 4 hours	393.4 (18.53)
QTcB Interval: Day 5, Pre-dose	399.2 (16.61)
QTcB Interval: Day 5, 2 hours	400.7 (20.02)
QTcB Interval: Day 5, 4 hours	403.2 (13.41)

118. Secondary Outcome

Title	Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
Description	Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.
Time Frame	Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
PR Interval: Day 1, 2 hours	167.9 (13.86)
PR Interval: Day 1, 4 hours	164.1 (15.12)
PR Interval: Day 4, Pre-dose	165.6 (16.02)
PR Interval: Day 4, 2 hours	166.9 (15.67)
PR Interval: Day 4, 4 hours	163.1 (15.13)
PR Interval: Day 5, Pre-dose	164.6 (18.30)
PR Interval: Day 5, 2 hours	162.8 (12.71)
PR Interval: Day 5, 4 hours	163.3 (14.96)
PR Interval: Day 7, Pre-dose	169.6 (17.47)
PR Interval: Day 7, 2 hours	165.0 (15.69)
PR Interval: Day 7, 4 hours	165.6 (15.00)
PR Interval: Day 10	168.3 (17.14)
QRS Duration: Day 1, 2 hours	95.9 (10.49)
QRS Duration: Day 1, 4 hours	92.8 (8.76)
QRS Duration: Day 4, Pre-dose	96.8 (9.41)
QRS Duration: Day 4, 2 hours	93.5 (8.21)
QRS Duration: Day 4, 4 hours	95.3 (8.79)
QRS Duration: Day 5, Pre-dose	96.6 (9.77)
QRS Duration: Day 5, 2 hours	96.1 (11.66)
QRS Duration: Day 5, 4 hours	94.3 (9.56)
QRS Duration: Day 7, Pre-dose	95.4 (9.44)
QRS Duration: Day 7, 2 hours	95.1 (9.52)
QRS Duration: Day 7, 4 hours	94.4 (9.30)
QRS Duration: Day 10	96.5 (9.14)
QT Interval: Day 1, 2 hours	380.0 (12.90)
QT Interval: Day 1, 4 hours	392.3 (16.39)
QT Interval: Day 4, Pre-dose	389.2 (18.65)
QT Interval: Day 4, 2 hours	376.6 (18.49)
QT Interval: Day 4, 4 hours	395.3 (17.89)
QT Interval: Day 5, Pre-dose	386.4 (18.49)
QT Interval: Day 5, 2 hours	380.9 (13.91)
QT Interval: Day 5, 4 hours	391.8 (20.53)
QT Interval: Day 7, Pre-dose	391.0 (21.99)
QT Interval: Day 7, 2 hours	382.3 (13.85)
QT Interval: Day 7, 4 hours	395.8 (20.94)
QT Interval: Day 10	392.9 (14.54)
QTcF Interval: Day 1, 2 hours	392.7 (11.45)
QTcF Interval: Day 1, 4 hours	399.7 (10.37)
QTcF Interval: Day 4, Pre-dose	395.8 (13.94)
QTcF Interval: Day 4, 2 hours	390.6 (12.33)
QTcF Interval: Day 4, 4 hours	401.2 (13.55)
QTcF Interval: Day 5, Pre-dose	399.2 (14.92)
QTcF Interval: Day 5, 2 hours	394.3 (12.83)
QTcF Interval: Day 5, 4 hours	401.7 (11.91)
QTcF Interval: Day 7, Pre-dose	395.1 (12.91)
QTcF Interval: Day 7, 2 hours	393.7 (12.69)
QTcF Interval: Day 7, 4 hours	396.8 (13.47)
QTcF Interval: Day 10	394.8 (13.08)
QTcB Interval: Day 1, 2 hours	398.4 (15.81)
QTcB Interval: Day 1, 4 hours	402.0 (15.46)
QTcB Interval: Day 4, Pre-dose	398.4 (17.82)
QTcB Interval: Day 4, 2 hours	394.0 (21.41)
QTcB Interval: Day 4, 4 hours	403.1 (17.67)
QTcB Interval: Day 5, Pre-dose	405.1 (23.00)
QTcB Interval: Day 5, 2 hours	400.1 (18.05)
QTcB Interval: Day 5, 4 hours	405.9 (16.27)
QTcB Interval: Day 7, Pre-dose	396.6 (17.50)
QTcB Interval: Day 7, 2 hours	398.9 (21.21)
QTcB Interval: Day 7, 4 hours	396.0 (18.10)
QTcB Interval: Day 10	394.8 (18.39)

119. Secondary Outcome

Title	Period 1: Absolute Values for SBP and DBP
Description	SBP and DBP were measured in the semi-recumbent position with a completely automated device.
Time Frame	Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
SBP: Day 2	118.8 (8.57)
SBP: Day 3	114.9 (8.09)
SBP: Day 4	119.0 (9.81)
SBP: Day 5	109.1 (7.16)
DBP: Day 2	76.1 (6.53)
DBP: Day 3	72.7 (8.32)
DBP: Day 4	74.1 (8.58)
DBP: Day 5	69.2 (9.77)

120. Secondary Outcome

Title	Period 2: Absolute Values for SBP and DBP
Description	SBP and DBP were measured in the semi-recumbent position with a completely automated device.
Time Frame	Days 2, 3, 4, 5, 6 and 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
SBP: Day 2	115.8 (7.15)
SBP: Day 3	115.3 (7.57)
SBP: Day 4	117.1 (8.74)
SBP: Day 5	113.6 (7.35)
SBP: Day 6	113.9 (8.29)
SBP: Day 7	114.6 (5.73)
DBP: Day 2	69.6 (8.50)
DBP: Day 3	71.1 (7.65)
DBP: Day 4	69.6 (5.24)
DBP: Day 5	68.8 (6.49)
DBP: Day 6	70.3 (7.02)
DBP: Day 7	70.4 (6.65)

121. Secondary Outcome

Title	Period 3: Absolute Values for SBP and DBP
Description	SBP and DBP were measured in the semi-recumbent position with a completely automated device.
Time Frame	Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
SBP: Day 2	115.8 (8.12)
SBP: Day 3	112.5 (5.81)
SBP: Day 4	112.6 (6.11)
SBP: Day 5	119.4 (19.70)
SBP: Day 6	114.4 (7.45)
SBP: Day 7	113.8 (8.13)
SBP: Day 8	113.9 (6.72)
SBP: Day 9	113.6 (7.67)
SBP: Day 10	111.6 (6.38)
SBP: Day 11	112.4 (7.69)
DBP: Day 2	69.0 (6.46)
DBP: Day 3	67.7 (6.52)
DBP: Day 4	68.9 (6.33)
DBP: Day 5	74.4 (21.90)
DBP: Day 6	69.2 (8.27)
DBP: Day 7	70.6 (5.78)
DBP: Day 8	69.5 (9.34)
DBP: Day 9	69.8 (5.98)
DBP: Day 10	70.0 (5.14)
DBP: Day 11	67.7 (4.32)

122. Secondary Outcome

Title	Period 1: Absolute Values for Pulse Rate
Description	Pulse rate was measured in the semi-recumbent position with a completely automated device.
Time Frame	Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Day 2	67.8 (8.47)
Day 3	66.8 (6.68)
Day 4	70.1 (10.57)
Day 5	66.4 (8.21)

123. Secondary Outcome

Title	Period 2: Absolute Values for Pulse Rate
Description	Pulse rate was measured in the semi-recumbent position with a completely automated device.
Time Frame	Days 2, 3, 4, 5, 6 and 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Day 2	68.3 (9.75)
Day 3	69.7 (8.65)
Day 4	69.1 (8.21)
Day 5	68.5 (11.14)
Day 6	68.1 (8.88)
Day 7	67.0 (8.95)

124. Secondary Outcome

Title	Period 3: Absolute Values for Pulse Rate
Description	Pulse rate was measured in the semi-recumbent position with a completely automated device.
Time Frame	Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 2	68.4 (9.79)
Day 3	68.9 (8.63)
Day 4	66.9 (9.26)
Day 5	69.8 (10.57)
Day 6	67.9 (10.12)
Day 7	64.6 (8.02)
Day 8	69.0 (12.02)
Day 9	65.9 (10.12)
Day 10	63.8 (8.53)
Day 11	68.4 (12.27)

125. Secondary Outcome

Title	Period 1: Absolute Values for Respiratory Rate
Description	Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame	Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Day 2	13.5 (1.37)
Day 3	14.6 (2.16)
Day 4	12.9 (1.78)
Day 5	13.6 (2.22)

126. Secondary Outcome

Title	Period 2: Absolute Values for Respiratory Rate
Description	Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame	Days 2, 3, 4, 5, 6 and 7

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Day 2, n=16	13.6 (0.81)
Day 3, n=16	14.5 (2.00)
Day 4, n=16	13.5 (1.15)
Day 5, n=15	15.3 (2.09)
Day 6, n=16	13.8 (2.52)
Day 7, n=16	14.3 (2.18)

127. Secondary Outcome

Title	Period 3: Absolute Values for Respiratory Rate
Description	Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame	Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 2	15.0 (2.42)
Day 3	14.1 (1.54)
Day 4	13.9 (2.96)
Day 5	13.1 (1.45)
Day 6	14.3 (2.05)
Day 7	13.9 (1.86)
Day 8	15.0 (1.03)
Day 9	13.3 (3.00)
Day 10	15.0 (1.79)
Day 11	16.4 (1.31)

128. Secondary Outcome

Title	Period 1: Absolute Values for Body Temperature
Description	Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame	Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Day 2	36.36 (0.303)
Day 3	36.26 (0.287)
Day 4	36.21 (0.361)
Day 5	36.43 (0.270)

129. Secondary Outcome

Title	Period 2: Absolute Values for Body Temperature
Description	Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame	Days 2, 3, 4, 5, 6 and 7

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Day 2	36.26 (0.339)
Day 3	36.15 (0.361)
Day 4	36.21 (0.318)
Day 5	36.35 (0.306)
Day 6	36.28 (0.309)
Day 7	36.28 (0.394)

130. Secondary Outcome

Title	Period 3: Absolute Values for Body Temperature
Description	Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame	Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Day 2	36.33 (0.284)
Day 3	36.22 (0.369)
Day 4	36.42 (0.412)
Day 5	36.40 (0.405)
Day 6	36.37 (0.366)
Day 7	36.46 (0.371)
Day 8	36.28 (0.451)
Day 9	36.30 (0.337)
Day 10	36.37 (0.294)
Day 11	36.53 (0.307)

131. Secondary Outcome

Title	Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 for GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Median (Full Range) [Hours]	5.000

132. Secondary Outcome

Title	Period 3: Tmax of GSK3640254 for Dolutegravir + GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Median (Full Range) [Hours]	5.000

133. Secondary Outcome

Title	Period 2: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 for GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Data could not be determined due to limited sampling points after final dosing (during elimination phase). An accurate determination of GSK3640254 half-life would require sampling up to 3 times half-life (3 * approximately 24 hours). However sampling in Period 2 was performed up to only 24 hours post-dose.
Time Frame	Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	GSK3640254 200 mg
Arm/Group Description	In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Hours]	NA (NA)

134. Secondary Outcome

Title	Period 3: T1/2 of GSK3640254 for Dolutegravir + GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Hours]	23.417 (15.0)

135. Secondary Outcome

Title	Period 1: Tmax of Dolutegravir for Dolutegravir Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Median (Full Range) [Hours]	3.000

136. Secondary Outcome

Title	Period 3: Tmax of Dolutegravir for Dolutegravir + GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Median (Full Range) [Hours]	3.000

137. Secondary Outcome

Title	Period 1: T1/2 of Dolutegravir for Dolutegravir Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Hours]	14.492 (11.8)

138. Secondary Outcome

Title	Period 3: T1/2 of Dolutegravir for Dolutegravir + GSK3640254 Arm
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame	Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Parameter Population.

Arm/Group Title	Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Hours]	14.690 (12.1)

Adverse Events

Time Frame	Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Adverse Event Reporting Description	Safety Population consisted of all participants who received at least 1 dose of study medication.
Arm/Group Title	Dolutegravir 50 mg		GSK3640254 200 mg		Dolutegravir 50 mg + GSK3640254 200 mg
Arm/Group Description	In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2.		In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7.		In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment.
All Cause Mortality
	Dolutegravir 50 mg		GSK3640254 200 mg		Dolutegravir 50 mg + GSK3640254 200 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)		0/16 (0%)
Serious Adverse Events
	Dolutegravir 50 mg		GSK3640254 200 mg		Dolutegravir 50 mg + GSK3640254 200 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Dolutegravir 50 mg		GSK3640254 200 mg		Dolutegravir 50 mg + GSK3640254 200 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/16 (6.3%)		3/16 (18.8%)		2/16 (12.5%)
Ear and labyrinth disorders
Ear pruritus	0/16 (0%)		0/16 (0%)		1/16 (6.3%)
General disorders
Medical device site dermatitis	0/16 (0%)		1/16 (6.3%)		1/16 (6.3%)
Fatigue	0/16 (0%)		0/16 (0%)		1/16 (6.3%)
Injury, poisoning and procedural complications
Skin abrasion	1/16 (6.3%)		0/16 (0%)		0/16 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/16 (0%)		1/16 (6.3%)		0/16 (0%)
Psychiatric disorders
Anxiety	0/16 (0%)		1/16 (6.3%)		0/16 (0%)
Skin and subcutaneous tissue disorders
Dermatitis	0/16 (0%)		0/16 (0%)		1/16 (6.3%)
Dermatitis contact	0/16 (0%)		0/16 (0%)		1/16 (6.3%)
Keratosis pilaris	0/16 (0%)		1/16 (6.3%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.