Study to Evaluate the Effect of GSK3640254 on the Pharmacokinetics of Tenofovir Alafenamide/Emtricitabine

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03836729
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

Human immunodeficiency virus (HIV) infection frequently involves combination drug therapy for its treatment; hence, it is important to understand their interactions and resulting changes in exposure which are associated with medications. This is a Phase-1, open-label, fixed-sequence 2-period, one-way drug interaction study to assess the pharmacokinetic (PK), safety, and tolerability of GSK3640254 and Tenofovir alafenamide/emtricitabine (TAF/FTC) when administered alone and in combination in healthy subjects. The study will consist of a screening period of 28 days before the first dose of study intervention followed by 2 sequential treatment periods. Subjects will be administered TAF/FTC 25/200 milligram (mg) once daily (QD) on Days 1 to 14 of Period 1 followed by co-administration of TAF/FTC 25/200 mg QD with GSK3640254 200 mg QD on Days 1 to 7 of Period 2.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Tenofovir alafenamide/emtricitabine; Drug: GSK3640254	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Intervention Model: Sequential Assignment
• Intervention Model Description: This is a fixed-sequence 2-period, one-way drug interaction studyThis is a fixed-sequence 2-period, one-way drug interaction study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label One-way Interaction Clinical Trial to Evaluate the Pharmacokinetic Interactions Between GSK3640254 and Tenofovir Alafenamide/Emtricitabine in Healthy Subjects
• Actual Study Start Date: Feb 11, 2019
• Actual Primary Completion Date: Mar 30, 2019
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAF/FTC followed by TAF/FTC + GSK3640254 Subjects will receive TAF/FTC 25/200 mg QD on Days 1 through 14 in Treatment Period 1. Subjects will be co-administered TAF/FTC 25/200 mg QD with GSK3640254 200 mg QD on Days 1 through 7 in Treatment Period 2.	Drug: Tenofovir alafenamide/emtricitabine; TAF/FTC will be available as 25/200 milligrams (mg) tablet. Subjects will be administered TAF/FTC 25/200 mg QD via the oral route.; Drug: GSK3640254; GSK3640254 will be available as 100 mg capsule. Subjects will be administered GSK3640254 200 mg capsule 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 Interval at Steady State (AUC [0-tau]) of TAF [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14]

   Blood samples were collected at indicated time-points for analysis of AUC (0-tau). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.

2. Period 2: AUC (0-tau) of TAF [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

   Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

3. Period 1: Maximum Observed Concentration (Cmax) of TAF [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14]

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

4. Period 2: Cmax of TAF [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

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

5. Period 1: AUC (0-tau) of FTC [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14]

   Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

6. Period 2: AUC (0-tau) of FTC [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

   Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

7. Period 1:Cmax of FTC [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14]

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

8. Period 2:Cmax of FTC [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

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

9. Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14]

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

10. Period 2: Ctau of FTC [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

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

11. Period 1: AUC (0-tau) of Tenofovir (TFV) [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14]

    Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

12. Period 2: AUC (0-tau) of TFV [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

    Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

13. Period 1: Cmax of TFV [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14]

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

14. Period 2: Cmax of TFV [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

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

15. Period 1: Ctau of TFV [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14]

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

16. Period 2: Ctau of TFV [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

    Blood samples were collected at indicated time-points for analysis of Ctau. PK 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 (SAE) [Up to Day 24]

   An adverse events (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. 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; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before

2. Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils [Baseline and at Days 7, and 14]

   Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

3. Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils [Baseline and at Days 3, 7, 9]

   Blood samples were collected at indicated timepoints for analysis for hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

4. Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils [Baseline and at Days 7, and 14]

   Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1.

5. Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils [Baseline and at Days 3, 7, 9]

   Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2.

6. Period 1: Change From Baseline in Hematology Parameter of Hematocrit [Baseline and at Days 7, 14]

   Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

7. Period 2: Change From Baseline in Hematology Parameter of Hematocrit [Baseline and at Days 3, 7, 9]

   Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

8. Period 1: Absolute Values of the Hematology Parameter: Hematocrit [Baseline and at Days 7, 14]

   Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1.

9. Period 2: Absolute Values of the Hematology Parameter: Hematocrit [Baseline and at Days 3, 7, 9]

   Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2.

10. Period 1: Change From Baseline in Hematology Parameter of Hemoglobin [Baseline and at Days 7, 14]

    Blood samples were collected at indicated timepoints for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

11. Period 2: Change From Baseline in Hematology Parameter of Hemoglobin [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

12. Period 1: Absolute Values of the Hematology Parameter: Hemoglobin [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1.

13. Period 2: Absolute Values of the Hematology Parameter: Hemoglobin [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2.

14. Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) [Baseline and at Days 7, 14]

    Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

15. Period 2: Change From Baseline in Hematology Parameter of MCH [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

16. Period 1: Absolute Values of the Hematology Parameter: MCH [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1.

17. Period 2: Absolute Values of the Hematology Parameter: MCH [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis of hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2.

18. Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

19. Period 2: Change From Baseline in Hematology Parameter of MCV [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

20. Period 1: Absolute Values of the Hematology Parameter: MCV [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1.

21. Period 2: Absolute Values of the Hematology Parameter: MCV [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2.

22. Period 1: Change From Baseline in Hematology Parameter of Erythrocytes [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

23. Period 2: Change From Baseline in Hematology Parameter of Erythrocytes [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

24. Period 1: Absolute Values of the Hematology Parameter: Erythrocytes [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1.

25. Period 2: Absolute Values of the Hematology Parameter: Erythrocytes [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2.

26. Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

27. Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

28. Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1.

29. Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2.

30. Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK) [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter like alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

31. Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

32. Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1.

33. Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2.

34. Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

35. Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

36. Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1.

37. Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2.

38. Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

39. Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

40. Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1.

41. Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2.

42. Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

43. Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

44. Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin [Baseline and at Days 7, 14]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1.

45. Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin [Baseline and at Days 3, 7, 9]

    Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2.

46. Period 1: Change From Baseline in Specific Gravity of Urine [Baseline and at Days 7, 14]

    Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

47. Period 2: Change From Baseline in Specific Gravity of Urine [Baseline and at Days 3, 7, 9]

    Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

48. Period 1: Absolute Values of Specific Gravity of Urine [Baseline and at Days 7, 14]

    Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1.

49. Period 2: Absolute Values of Specific Gravity of Urine [Baseline and at Days 3, 7, 9]

    Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2.

50. Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine [Baseline and at Days 7, 14]

    Urine samples were collected at indicated time points for the assessment of Urinary 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 Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

51. Period 2: Change From Baseline in pH of Urine [Baseline and at Days 3, 7, 9]

    Urine samples were collected at indicated time points for the assessment of Urinary 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 Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

52. Period 1: Absolute Values of pH of Urine [Baseline and at Days 7, 14]

    Urine samples were collected at indicated time points for the assessment of Urinary 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 Day -1 for Period 1.

53. Period 2: Absolute Values of pH of Urine [Baseline and at Days 3, 7, 9]

    Urine samples were collected at indicated time points for the assessment of Urinary 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 Period 1 Day 14 for Period 2.

54. Period 1: Change From Baseline in Urine Urobilinogen [Baseline and at Days 7, 14]

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

55. Period 2: Change From Baseline in Urine Urobilinogen [Baseline and at Days 3, 7, 9]

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.

56. Period 1: Absolute Values of Urine Urobilinogen [Baseline and at Days 7, 14]

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1.

57. Period 2: Absolute Values of Urine Urobilinogen [Baseline and at Days 3, 7, 9]

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2.

58. Period 1: Change From Baseline in Heart Rate [Baseline and at Day 1, 2 and 4 hours post-dose]

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.

59. Period 2: Change From Baseline in Heart Rate [Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose]

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

60. Period 1: Absolute Values of Heart Rate [Baseline and at Day 1, 2 and 4 hours post-dose]

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

61. Period 2: Absolute Values of Heart Rate [Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose]

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period.

62. Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval [Baseline and at Day 1, 2 and 4 hours post-dose]

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

63. Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval [Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose]

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

64. Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval [Baseline and at Day 1, 2 and 4 hours post-dose]

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period.

65. Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval [Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose]

    Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period.

66. Period 1: Change From Baseline in Temperature [Baseline and at Days 2, 3, 4, 5 and 7]

    Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

67. Period 2: Change From Baseline in Temperature [Baseline and at Days 4, 7, 9, and 10]

    Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

68. Period 1: Absolute Values of Temperature [Baseline and at Days 2, 3, 4, 5 and 7]

    Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

69. Period 2: Absolute Values of Temperature [Baseline and at Days 4, 7, 9, and 10]

    Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

70. Period 1: Change From Baseline in Pulse Rate [Baseline and at Days 2, 3, 4, 5 and 7]

    Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

71. Period 2: Change From Baseline in Pulse Rate [Baseline and at Days 4, 7, 9, and 10]

    Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

72. Period 1: Absolute Values of Pulse Rate [Baseline and at Days 2, 3, 4, 5 and 7]

    Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

73. Period 2: Absolute Values of Pulse Rate [Baseline and at Days 4, 7, 9, and 10]

    Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

74. Period 1: Change From Baseline in Respiratory Rate [Baseline and at Days 2, 3, 4, 5 and 7]

    Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

75. Period 2: Change From Baseline in Respiratory Rate [Baseline and at Days 4, 7, 9, and 10]

    Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

76. Period 1: Absolute Values of Respiratory Rate [Baseline and at Days 2, 3, 4, 5 and 7]

    Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

77. Period 2: Absolute Values of Respiratory Rate [Baseline and at Days 4, 7, 9, and 10]

    Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

78. Period 1: Change From Baseline in Blood Pressure [Baseline and at Days 2, 3, 4, 5 and 7]

    Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

79. Period 2: Change From Baseline in Blood Pressure [Baseline and at Days 4, 7, 9, and 10]

    SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.

80. Period 1: Absolute Values of Blood Pressure [Baseline and at Days 2, 3, 4, 5 and 7]

    SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

81. Period 2: Absolute Values of Blood Pressure [Baseline and at Days 4, 7, 9, and 10]

    SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.

82. Period 2: AUC (0-tau) of GSK3640254 [Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

    Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.

83. Period 2: Cmax of GSK3640254 [Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

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

84. Period 2: Ctau of GSK3640254 [Pre-dose, 1 and 2 hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

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

85. Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 [Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

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

86. Period 1: Tmax of TAF [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14]

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

87. Period 2: Tmax of TAF [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

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

88. Period 1: Tmax of FTC [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14]

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

89. Period 2: Tmax of FTC [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

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

90. Period 1: Tmax of TFV [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14]

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

91. Period 2: Tmax of TFV [Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7]

    Blood samples were collected at indicated time-points for analysis of Tmax. PK 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 >=50.0 kilograms (kg) (110 pound [lbs]) for men and >=45.0 kilograms [kg] (99 lbs) for women and body mass index (BMI) within the range 18.5 to 31.0 kilograms per meter square (kg/m^2) (inclusive).

• Male or female; 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.

• History of any kidney disease or current or chronic history of impaired renal function as indicated by an estimated creatinine clearance <80 milliliters per minute (mL/min). Creatinine clearance (CrCL) is estimated by either of the following methods: (a) The Modification of Diet in Renal Disease (MDRD) equation: estimated glomerular filtration rate (eGFR) (milliliter [mL]/minute [min]/1.73 meter square [m^{2]) = 175 x (SCr)}-1.154 x (Age)^{-0.203 x 0.742 [if female] x 1.212 [if African American] glomerular filtration rate (GFR) is expressed in mL/min/1.73 m}2, SCr is serum creatinine expressed in milligrams per deciliter (mg/dL), and age is expressed in years. (b)The Cockcroft-Gault equation: CrCL(mL/min) ={((l40-age) x weight)/(72xSCr)}x 0.85 (if female) CrCL is expressed in mL/min, age is expressed in years, weight is expressed in kg, and SCr is serum creatinine expressed in mg/dL.

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

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

• 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, etc), and ALT (described above), will exclude a subject from the study unless the investigator can provide a compelling explanation for the laboratory result(s) 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 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 VH/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 for male: <45 or >100 beats per minute (bpm) and for females: <50 or >100 bpm; PR interval: <120 or >200 milliseconds (msec); QRS duration: <70 or >110 msec and QTcF interval for male: >450 msec and for female: >470 msec. A heart rate from 100 to 110 bpm can be rechecked by ECG or vital signs within 30 minutes to verify eligibility.

• 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)

• Statistical Analysis Plan - Apr 29, 2019
• Study Protocol - Dec 27, 2018

More Information

Publications

None provided.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT03836729
• Other Study ID Numbers: 208134
• First Posted: Feb 11, 2019
• Last Update Posted: Apr 21, 2020
• Last Verified: Apr 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: Human immunodeficiency virus; Sequential; Tenofovir alafenamide; Emtricitabine; GSK3640254
• Additional relevant MeSH terms: HIV Infections; Tenofovir; Emtricitabine

Study Results

Participant Flow

Recruitment Details	This was an open-label, single-sequence one-way interaction drug interaction study to investigate the effect of GSK3640254 on the pharmacokinetics (PK) of tenofovir alafenamide (TAF) and emtricitabine (FTC).
Pre-assignment Detail	A total of 16 participants were enrolled in the study.

Arm/Group Title	TAF/FTC Followed by TAF/FTC+GSK3640254
Arm/Group Description	Participants in Period 1 received 25 milligram (mg) of TAF and 200 mg of FTC once daily (QD) on Days 1 through 14. In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Period Title: Treatment Period 1 (Up to Day 14)
STARTED	16
COMPLETED	16
NOT COMPLETED	0
Period Title: Treatment Period 1 (Up to Day 14)
STARTED	16
COMPLETED	15
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	TAF/FTC Followed by TAF/FTC+GSK3640254
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Overall Participants	16
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	33.9 (9.67)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	16 100%
Race/Ethnicity, Customized (Number) [Number]
American Indian or Alaska Native	1 6.3%
Asian: East Asian Heritage	1 6.3%
Black or African American	7 43.8%
Native Hawaiian or other pacific islander	1 6.3%
White:White/Caucasian/European Heritage	6 37.5%

Outcome Measures

1. Primary Outcome

Title	Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF
Description	Blood samples were collected at indicated time-points for analysis of AUC (0-tau). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Hours*nanogram per milliliter]	250.4 (58.2)

2. Primary Outcome

Title	Period 2: AUC (0-tau) of TAF
Description	Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Geometric Mean (Geometric Coefficient of Variation) [Hours*nanogram per milliliter]	215.4 (36.3)

3. Primary Outcome

Title	Period 1: Maximum Observed Concentration (Cmax) of TAF
Description	Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	203.4 (56.1)

4. Primary Outcome

Title	Period 2: Cmax of TAF
Description	Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	175.1 (44.4)

5. Primary Outcome

Title	Period 1: AUC (0-tau) of FTC
Description	Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Hours*nanogram per milliliter]	9787.5 (15.5)

6. Primary Outcome

Title	Period 2: AUC (0-tau) of FTC
Description	Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Geometric Mean (Geometric Coefficient of Variation) [Hours*nanogram per milliliter]	9421.0 (14.4)

7. Primary Outcome

Title	Period 1:Cmax of FTC
Description	Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	1811 (15.9)

8. Primary Outcome

Title	Period 2:Cmax of FTC
Description	Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	1701 (20.9)

9. Primary Outcome

Title	Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC
Description	Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	71.81 (25.5)

10. Primary Outcome

Title	Period 2: Ctau of FTC
Description	Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	82.92 (29.1)

11. Primary Outcome

Title	Period 1: AUC (0-tau) of Tenofovir (TFV)
Description	Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Hours*nanogram per milliliter]	221.9 (18.3)

12. Primary Outcome

Title	Period 2: AUC (0-tau) of TFV
Description	Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Geometric Mean (Geometric Coefficient of Variation) [Hours*nanogram per milliliter]	229.1 (21.5)

13. Primary Outcome

Title	Period 1: Cmax of TFV
Description	Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	13.14 (17.8)

14. Primary Outcome

Title	Period 2: Cmax of TFV
Description	Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	13.30 (20.8)

15. Primary Outcome

Title	Period 1: Ctau of TFV
Description	Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	7.688 (20.4)

16. Primary Outcome

Title	Period 2: Ctau of TFV
Description	Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	8.244 (22.9)

17. Secondary Outcome

Title	Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)
Description	An adverse events (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. 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; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before
Time Frame	Up to Day 24

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received at least 1 dose of study medication.

Arm/Group Title	TAF/FTC	TAF/FTC+GSK3640254
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16	15
Non-SAEs	9 56.3%	3 NaN
SAEs	0 0%	0 NaN

18. Secondary Outcome

Title	Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Description	Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, and 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Basophils, Period 1 Day 7	-0.005 (0.0167)
Basophils, Period 1 Day 14	-0.006 (0.0260)
Eosinophils, Period 1 Day 7	-0.021 (0.0795)
Eosinophils, Period 1 Day 14	-0.020 (0.1531)
Monocytes, Period 1 Day 7	0.014 (0.1808)
Monocytes, Period 1 Day 14	0.049 (0.2718)
Leukocytes, Period 1 Day 7	-0.08 (1.795)
Leukocytes, Period 1 Day 14	0.27 (2.191)
Lymphocytes, Period 1 Day 7	-0.246 (0.3089)
Lymphocytes, Period 1 Day 14	-0.262 (0.4138)
Neutrophils, Period 1 Day 7	0.188 (1.5473)
Neutrophils, Period 1 Day 14	0.513 (1.7986)
Platelets, Period 1 Day 7	3.3 (21.23)
Platelets, Period 1 Day 14	21.8 (35.37)

19. Secondary Outcome

Title	Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Description	Blood samples were collected at indicated timepoints for analysis for hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Basophils, Period 2 Day 3, n= 15	-0.004 (0.0196)
Basophils, Period 2 Day 7, n= 15	-0.002 (0.0204)
Basophils, Period 2 Day 9, n= 15	0.003 (0.0150)
Eosinophils, Period 2 Day 3, n=15	-0.023 (0.0811)
Eosinophils, Period 2 Day 7, n=15	-0.039 (0.1058)
Eosinophils, Period 2 Day 9, n=16	-0.043 (0.1093)
Monocytes, Period 2 Day 3, n= 16	-0.053 (0.1895)
Monocytes, Period 2 Day 7, n= 15	-0.077 (0.1709)
Monocytes, Period 2 Day 9, n= 15	-0.104 (0.1672)
Leukocytes, Period 2 Day 3, n= 16	-1.06 (1.188)
Leukocytes, Period 2 Day 7, n= 15	-0.61 (1.050)
Leukocytes, Period 2 Day 9, n= 15	-0.49 (1.193)
Lymphocytes, Period 2 Day 3, n= 16	-0.158 (0.2296)
Lymphocytes, Period 2 Day 7, n= 15	-0.105 (0.2306)
Lymphocytes, Period 2 Day 9, n= 15	-0.111 (0.2728)
Neutrophils, Period 2 Day 3, n= 16	-0.868 (0.9597)
Neutrophils, Period 2 Day 7, n= 15	-0.417 (0.9069)
Neutrophils, Period 2 Day 9, n= 15	-0.282 (1.0161)
Platelets, Period 2 Day 3, n= 16	9.2 (20.41)
Platelets, Period 2 Day 7, n= 15	19.8 (43.02)
Platelets, Period 2 Day 9, n= 15	16.2 (38.11)

20. Secondary Outcome

Title	Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Description	Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1.
Time Frame	Baseline and at Days 7, and 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Basophils, Period 1 Baseline	0.046 (0.0216)
Basophils, Period 1 Day 7	0.041 (0.0189)
Basophils, Period 1 Day 14	0.040 (0.0256)
Eosinophils, Period 1 Baseline	0.225 (0.1918)
Eosinophils, Period 1 Day 7	0.204 (0.1737)
Eosinophils, Period 1 Day 14	0.205 (0.1766)
Monocytes, Period 1 Baseline	0.522 (0.1147)
Monocytes, Period 1 Day 7	0.536 (0.2063)
Monocytes, Period 1 Day 14	0.571 (0.2830)
Leukocytes, Period 1 Baseline	6.18 (1.336)
Leukocytes, Period 1 Day 7	6.10 (2.024)
Leukocytes, Period 1 Day 14	6.45 (2.231)
Lymphocytes, Period 1 Baseline	1.945 (0.7419)
Lymphocytes, Period 1 Day 7	1.699 (0.5822)
Lymphocytes, Period 1 Day 14	1.683 (0.4988)
Neutrophils, Period 1 Baseline	3.441 (0.9719)
Neutrophils, Period 1 Day 7	3.628 (1.9503)
Neutrophils, Period 1 Day 14	3.954 (1.9141)
Platelets, Period 1 Baseline	253.3 (49.81)
Platelets, Period 1 Day 7	256.6 (49.72)
Platelets, Period 1 Day 14	275.1 (53.39)

21. Secondary Outcome

Title	Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Description	Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Basophils, Period 2 Baseline, n= 16	0.040 (0.0256)
Basophils, Period 2 Day 3, n= 15	0.036 (0.0182)
Basophils, Period 2 Day 7, n= 15	0.038 (0.0152)
Basophils, Period 2 Day 9, n= 15	0.043 (0.0232)
Eosinophils, Period 2 Baseline, n= 16	0.208 (0.1764)
Eosinophils, Period 2 Day 3, n= 15	0.185 (0.1533)
Eosinophils, Period 2 Day 7, n= 15	0.157 (0.1405)
Eosinophils, Period 2 Day 9, n= 16	0.153 (0.1384)
Monocytes, Period 2 Baseline, n= 16	0.545 (0.2127)
Monocytes, Period 2 Day 3, n= 16	0.492 (0.1975)
Monocytes, Period 2 Day 7, n= 15	0.448 (0.1472)
Monocytes, Period 2 Day 9, n= 15	0.421 (0.1212)
Leukocytes, Period 2 Baseline, n= 16	6.20 (1.752)
Leukocytes, Period 2 Day 3, n= 16	5.14 (1.035)
Leukocytes, Period 2 Day 7, n= 15	5.39 (1.311)
Leukocytes, Period 2 Day 9, n= 15	5.51 (1.415)
Lymphocytes, Period 2 Baseline, n= 16	1.718 (0.4814)
Lymphocytes, Period 2 Day 3, n= 16	1.560 (0.3786)
Lymphocytes, Period 2 Day 7, n= 15	1.570 (0.4116)
Lymphocytes, Period 2 Day 9, n= 15	1.563 (0.4236)
Neutrophils, Period 2 Baseline, n= 16	3.724 (1.3787)
Neutrophils, Period 2 Day 3, n= 16	2.857 (0.8106)
Neutrophils, Period 2 Day 7, n= 15	3.189 (1.0515)
Neutrophils, Period 2 Day 9, n= 15	3.324 (1.1988)
Platelets, Period 2 Baseline, n= 16	274.3 (51.10)
Platelets, Period 2 Day 3, n= 16	283.4 (54.62)
Platelets, Period 2 Day 7, n= 15	294.0 (54.62)
Platelets, Period 2 Day 9, n= 15	290.4 (73.92)

22. Secondary Outcome

Title	Period 1: Change From Baseline in Hematology Parameter of Hematocrit
Description	Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Day 7	0.0121 (0.01389)
Day 14	0.0189 (0.01304)

23. Secondary Outcome

Title	Period 2: Change From Baseline in Hematology Parameter of Hematocrit
Description	Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Day 3, n= 16	-0.0147 (0.00982)
Day 7, n= 15	-0.0007 (0.01369)
Day 9, n= 15	-0.0204 (0.01371)

24. Secondary Outcome

Title	Period 1: Absolute Values of the Hematology Parameter: Hematocrit
Description	Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Baseline	0.4264 (0.01891)
Day 7	0.4384 (0.02358)
Day 14	0.4453 (0.01997)

25. Secondary Outcome

Title	Period 2: Absolute Values of the Hematology Parameter: Hematocrit
Description	Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Baseline, n= 16	0.4453 (0.01997)
Day 3, n= 16	0.4306 (0.01780)
Day 7, n= 15	0.4444 (0.02234)
Day 9, n= 15	0.4247 (0.01518)

26. Secondary Outcome

Title	Period 1: Change From Baseline in Hematology Parameter of Hemoglobin
Description	Blood samples were collected at indicated timepoints for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Day 7	6.1 (4.51)
Day 14	8.4 (3.98)

27. Secondary Outcome

Title	Period 2: Change From Baseline in Hematology Parameter of Hemoglobin
Description	Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Day 3, n= 16	-3.9 (3.51)
Day 7, n= 15	-1.1 (4.58)
Day 9, n= 15	-6.4 (5.55)

28. Secondary Outcome

Title	Period 1: Absolute Values of the Hematology Parameter: Hemoglobin
Description	Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Baseline	142.0 (6.70)
Day 7	148.1 (8.11)
Day 14	150.4 (7.45)

29. Secondary Outcome

Title	Period 2: Absolute Values of the Hematology Parameter: Hemoglobin
Description	Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Baseline, n= 16	150.4 (7.45)
Day 3, n= 16	146.4 (6.37)
Day 7, n= 15	149.1 (7.26)
Day 9, n= 15	143.9 (5.19)

30. Secondary Outcome

Title	Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH)
Description	Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Day 7	0.13 (0.272)
Day 14	0.36 (0.276)

31. Secondary Outcome

Title	Period 2: Change From Baseline in Hematology Parameter of MCH
Description	Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Day 3, n= 16	-0.11 (0.205)
Day 7, n= 15	-0.21 (0.203)
Day 9, n= 15	-0.17 (0.253)

32. Secondary Outcome

Title	Period 1: Absolute Values of the Hematology Parameter: MCH
Description	Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Baseline	28.63 (1.780)
Day 7	28.75 (1.687)
Day 14	28.98 (1.690)

33. Secondary Outcome

Title	Period 2: Absolute Values of the Hematology Parameter: MCH
Description	Blood samples were collected at indicated time-points for analysis of hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Baseline, n= 16	28.98 (1.690)
Day 3, n= 16	28.88 (1.699)
Day 7, n= 15	28.83 (1.630)
Day 9, n= 15	28.87 (1.702)

34. Secondary Outcome

Title	Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV)
Description	Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Day 7	-0.83 (0.620)
Day 14	-0.07 (0.712)

35. Secondary Outcome

Title	Period 2: Change From Baseline in Hematology Parameter of MCV
Description	Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Day 3, n= 16	-1.02 (0.483)
Day 7, n= 15	-0.17 (0.472)
Day 9, n= 15	-0.82 (0.499)

36. Secondary Outcome

Title	Period 1: Absolute Values of the Hematology Parameter: MCV
Description	Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Baseline	85.92 (4.690)
Day 7	85.09 (4.504)
Day 14	85.85 (4.492)

37. Secondary Outcome

Title	Period 2: Absolute Values of the Hematology Parameter: MCV
Description	Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Baseline, n= 16	85.85 (4.492)
Day 3, n= 16	84.83 (4.490)
Day 7, n= 15	85.85 (4.491)
Day 9, n= 15	85.20 (4.601)

38. Secondary Outcome

Title	Period 1: Change From Baseline in Hematology Parameter of Erythrocytes
Description	Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Day 7	0.189 (0.1485)
Day 14	0.226 (0.1360)

39. Secondary Outcome

Title	Period 2: Change From Baseline in Hematology Parameter of Erythrocytes
Description	Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Day 3, n= 16	-0.113 (0.1123)
Day 7, n= 15	0.000 (0.1466)
Day 9, n= 15	-0.189 (0.1697)

40. Secondary Outcome

Title	Period 1: Absolute Values of the Hematology Parameter: Erythrocytes
Description	Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Baseline	4.977 (0.3351)
Day 7	5.166 (0.3679)
Day 14	5.203 (0.3604)

41. Secondary Outcome

Title	Period 2: Absolute Values of the Hematology Parameter: Erythrocytes
Description	Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Baseline, n= 16	5.203 (0.3604)
Day 3, n= 16	5.090 (0.3395)
Day 7, n= 15	5.190 (0.4087)
Day 9, n= 15	5.001 (0.3446)

42. Secondary Outcome

Title	Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Glucose, Day 7	-0.160 (0.3793)
Glucose, Day 14	-0.320 (0.3432)
Cholesterol, Day 7	-0.004 (0.3735)
Cholesterol, Day 14	-0.389 (0.3533)
Anion gap, Day 7	1.9 (2.08)
Anion gap, Day 14	2.2 (1.42)
Calcium, Day 7	0.028 (0.0780)
Calcium, Day 14	0.028 (0.0556)
CO2, Day 7	-1.6 (1.93)
CO2, Day 14	-0.9 (1.20)
Chloride, Day 7	-1.1 (1.06)
Chloride, Day 14	-2.0 (1.46)
Phosphate, Day 7	0.017 (0.0960)
Phosphate, Day 14	0.026 (0.1330)
Potassium, Day 7	0.03 (0.304)
Potassium, Day 14	-0.03 (0.328)
Sodium, Day 7	-0.6 (1.45)
Sodium, Day 14	-0.6 (1.59)
Triglycerides, Day 7	0.092 (0.4841)
Triglycerides, Day 14	-0.044 (0.4569)
BUN, Day 7	-0.018 (1.2157)
BUN, Day 14	-0.195 (1.0640)

43. Secondary Outcome

Title	Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Glucose, Day 3, n= 15	0.236 (0.2463)
Glucose, Day 7, n= 15	0.315 (0.3282)
Glucose, Day 9, n= 15	0.136 (0.2433)
Cholesterol, Day 3, n=15	0.011 (0.2372)
Cholesterol, Day 7, n= 15	0.102 (0.3899)
Cholesterol, Day 9, n= 16	0.030 (0.4594)
Anion gap, Day 3, n= 16	-0.4 (1.82)
Anion gap, Day 7, n= 15	-0.5 (1.73)
Anion gap, Day 9, n= 15	-0.3 (1.67)
Calcium, Day 3, n= 16	0.013 (0.0478)
Calcium, Day 7, n= 15	0.037 (0.0568)
Calcium, Day 9, n= 15	0.033 (0.0628)
CO2, Day 3, n= 16	-0.5 (1.26)
CO2, Day 7, n= 15	-0.1 (1.36)
CO2, Day 9, n= 15	-0.4 (1.18)
Chloride, Day 3, n= 16	2.3 (1.20)
Chloride, Day 7, n= 15	0.6 (1.35)
Chloride, Day 9, n= 15	1.3 (1.72)
Phosphate, Day 3, n= 16	0.062 (0.0683)
Phosphate, Day 7, n= 15	0.002 (0.0800)
Phosphate, Day 9, n= 15	0.007 (0.0584)
Potassium, Day 3, n= 16	0.01 (0.284)
Potassium, Day 7, n= 15	-0.03 (0.213)
Potassium, Day 9, n= 15	0.10 (0.344)
Sodium, Day 3, n= 16	1.4 (1.36)
Sodium, Day 7, n= 15	0.1 (1.53)
Sodium, Day 9, n= 15	0.6 (1.06)
Triglycerides, Day 3, n= 16	-0.003 (0.1753)
Triglycerides, Day 7, n= 15	0.111 (0.2414)
Triglycerides, Day 9, n= 15	-0.049 (0.2747)
BUN, Day 3, n= 16	0.312 (0.5567)
BUN, Day 7, n= 15	-0.031 (0.5038)
BUN, Day 9, n= 15	-0.028 (0.4521)

44. Secondary Outcome

Title	Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Description	Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Glucose, Baseline	5.111 (0.3747)
Glucose, Day 7	4.951 (0.2587)
Glucose, Day 14	4.791 (0.2662)
Cholesterol, Baseline	4.253 (0.7938)
Cholesterol, Day 7	4.249 (0.8494)
Cholesterol, Day 14	3.864 (0.6087)
Anion gap, Baseline	8.7 (1.08)
Anion gap, Day 7	10.6 (2.25)
Anion gap, Day 14	10.9 (1.45)
Calcium, Baseline	2.359 (0.0697)
Calcium, Day 7	2.387 (0.0663)
Calcium, Day 14	2.387 (0.0637)
CO2, Baseline	31.7 (1.49)
CO2, Day 7	30.1 (1.86)
CO2, Day 14	30.8 (1.38)
Chloride, Baseline	103.3 (1.84)
Chloride, Day 7	102.2 (1.72)
Chloride, Day 14	101.3 (2.32)
Phosphate, Baseline	1.078 (0.1301)
Phosphate, Day 7	1.094 (0.1202)
Phosphate, Day 14	1.103 (0.0807)
Potassium, Baseline	4.25 (0.225)
Potassium, Day 7	4.28 (0.161)
Potassium, Day 14	4.22 (0.279)
Sodium, Baseline	139.4 (1.45)
Sodium, Day 7	138.8 (1.77)
Sodium, Day 14	138.8 (1.69)
Triglycerides, Baseline	1.076 (0.5825)
Triglycerides, Day 7	1.168 (0.3759)
Triglycerides, Day 14	1.033 (0.3034)
BUN, Baseline	4.441 (1.2792)
BUN, Day 7	4.423 (0.9623)
BUN, Day 14	4.246 (0.7820)

45. Secondary Outcome

Title	Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Glucose, Baseline, n= 16	4.791 (0.2662)
Glucose, Day 3, n= 15	5.027 (0.2894)
Glucose, Day 7, n= 15	5.129 (0.3388)
Glucose, Day 9, n= 15	4.950 (0.3360)
Cholesterol, Baseline, n= 16	3.864 (0.6087)
Cholesterol, Day 3, n=15	3.875 (0.6509)
Cholesterol, Day 7, n= 15	3.894 (0.7575)
Cholesterol, Day 9, n= 16	3.822 (0.7838)
Anion gap, Baseline, n= 16	10.9 (1.45)
Anion gap, Day 3, n= 16	10.5 (1.37)
Anion gap, Day 7, n= 15	10.3 (1.28)
Anion gap, Day 9, n= 15	10.5 (0.74)
Calcium, Baseline, n= 16	2.387 (0.0637)
Calcium, Day 3, n= 16	2.399 (0.0682)
Calcium, Day 7, n= 15	2.424 (0.0693)
Calcium, Day 9, n= 15	2.421 (0.0670)
CO2, Baseline, n= 16	30.8 (1.38)
CO2, Day 3, n= 16	30.3 (1.96)
CO2, Day 7, n= 15	30.7 (1.91)
CO2, Day 9, n= 15	30.5 (1.30)
Chloride, Baseline, n= 16	101.3 (2.32)
Chloride, Day 3, n= 16	103.6 (1.50)
Chloride, Day 7, n= 15	101.9 (1.62)
Chloride, Day 9, n= 15	102.7 (1.50)
Phosphate, Baseline, n= 16	1.103 (0.0807)
Phosphate, Day 3, n= 16	1.165 (0.1007)
Phosphate, Day 7, n= 15	1.112 (0.1097)
Phosphate, Day 9, n= 15	1.117 (0.0952)
Potassium, Baseline, n= 16	4.22 (0.279)
Potassium, Day 3, n= 16	4.23 (0.241)
Potassium, Day 7, n= 15	4.21 (0.236)
Potassium, Day 9, n= 15	4.35 (0.226)
Sodium, Baseline, n= 16	138.8 (1.69)
Sodium, Day 3, n= 16	140.2 (1.56)
Sodium, Day 7, n= 15	138.8 (1.42)
Sodium, Day 9, n=15	139.3 (1.18)
Triglycerides, Baseline, n= 16	1.033 (0.3034)
Triglycerides, Day 3, n= 16	1.029 (0.3440)
Triglycerides, Day 7, n= 15	1.120 (0.4358)
Triglycerides, Day 9, n= 15	0.961 (0.4320)
BUN, Baseline, n= 16	4.246 (0.7820)
BUN, Day 3, n= 16	4.558 (0.8267)
BUN, Day 7, n= 15	4.260 (0.8705)
BUN Day 9, n= 15	4.263 (0.6977)

46. Secondary Outcome

Title	Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK)
Description	Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter like alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Alkaline phosphatase, Day 7	-2.6 (5.10)
Alkaline phosphatase, Day 14	2.4 (6.91)
AST, Day 7	-6.2 (4.59)
AST, Day 14	-6.9 (4.95)
ALT, Day 7	-2.1 (7.26)
ALT, Day 14	-6.2 (6.98)
GGT Day 7	0.2 (2.32)
GGT Day 14	-1.7 (3.63)
LDH, Day 7	-14.6 (13.07)
LDH, Day 14	-12.0 (16.25)
CK, Day 7	-103.0 (127.10)
CK, Day 14	-99.2 (135.80)

47. Secondary Outcome

Title	Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Alkaline phosphatase, Day 3, n= 16	3.7 (3.48)
Alkaline phosphatase, Day 7, n= 15	2.6 (3.64)
Alkaline phosphatase, Day 9, n= 15	-1.0 (3.98)
AST, Day 3, n= 16	-1.4 (1.31)
AST, Day 7, n= 15	-0.5 (2.45)
AST, Day 9, n= 15	-0.1 (2.13)
ALT, Day 3, n= 16	-2.0 (1.63)
ALT, Day 7, n= 15	-1.9 (2.76)
ALT, Day 9, n= 15	-0.7 (4.56)
GGT, Day 3, n= 16	-0.9 (1.18)
GGT, Day 7, n= 15	-1.4 (1.50)
GGT, Day 9, n= 15	-1.9 (2.55)
LDH, Day 3, n= 16	-7.0 (11.98)
LDH, Day 7, n= 15	-8.2 (12.73)
LDH, Day 9, n= 15	-7.0 (11.98)
CK, Day 3, n= 16	3.4 (29.12)
CK, Day 7, n= 15	11.3 (33.83)
CK, Day 9, n= 15	-2.3 (22.65)

48. Secondary Outcome

Title	Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Alkaline phosphatase, Baseline	60.9 (9.33)
Alkaline phosphatase, Day 7	58.3 (8.36)
Alkaline phosphatase, Day 14	63.4 (8.82)
AST, Baseline	24.6 (6.16)
AST, Day 7	18.4 (4.79)
AST, Day 14	17.6 (3.46)
ALT, Baseline	26.6 (10.44)
ALT, Day 7	24.4 (13.28)
ALT, Day 14	20.4 (8.59)
GGT Baseline	1.76 (1.016)
GGT Day 7	1.91 (0.752)
GGT Day 14	2.40 (1.035)
LDH, Baseline	138.0 (19.77)
LDH, Day 7	123.4 (19.67)
LDH, Day 9	126.0 (19.50)
CK, Baseline	219.6 (150.90)
CK, Day 7	116.6 (49.16)
CK, Day 14	120.4 (62.41)

49. Secondary Outcome

Title	Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Alkaline phosphatase, Baseline Day 3, n= 16	63.4 (8.82)
Alkaline phosphatase, Day 3, n= 16	67.1 (10.45)
Alkaline phosphatase, Day 7, n= 15	65.4 (9.81)
Alkaline phosphatase, Day 9, n= 15	61.8 (9.65)
AST, Baseline, n= 16	17.6 (3.46)
AST, Day 3, n= 16	16.2 (3.04)
AST, Day 7, n= 15	17.2 (3.38)
AST, Day 9, n= 15	17.6 (3.83)
ALT, Baseline, n= 16	20.4 (8.59)
ALT, Day 3, n= 16	18.4 (7.87)
ALT, Day 7, n= 15	18.5 (8.31)
ALT, Day 9, n= 15	19.7 (9.43)
GGT, Baseline, n= 16	2.40 (1.035)
GGT, Day 3, n= 16	2.14 (1.065)
GGT, Day 7, n= 15	2.41 (0.828)
GGT, Day 9, n= 15	1.95 (0.673)
LDH, Baseline, n= 16	126.0 (19.50)
LDH, Day 3, n= 16	119.0 (19.37)
LDH, Day 7, n= 15	118.0 (13.93)
LDH, Day 9, n= 15	119.2 (17.70)
CK, Baseline, n= 16	120.4 (62.41)
CK, Day 3, n= 16	123.8 (51.53)
CK, Day 7, n= 15	135.8 (66.33)
CK, Day 9, n= 15	122.2 (54.94)

50. Secondary Outcome

Title	Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Amylase, Day 7	-2.3 (9.68)
Amylase, Day 14	-2.8 (10.48)
Lipase, Day 7	-4.0 (8.93)
Lipase, Day 14	-5.3 (12.69)

51. Secondary Outcome

Title	Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Amylase, Day 3, n= 16	3.3 (8.93)
Amylase, Day 7, n= 15	-1.9 (6.77)
Amylase, Day 9, n= 15	1.1 (6.32)
Lipase, Day 3, n= 16	7.7 (21.62)
Lipase, Day 7, n= 15	0.0 (8.20)
Lipase, Day 9, n= 15	3.5 (3.89)

52. Secondary Outcome

Title	Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Amylase, Baseline	56.4 (14.66)
Amylase, Day 7	54.1 (13.15)
Amylase, Day 14	53.6 (14.48)
Lipase, Baseline	22.2 (14.00)
Lipase, Day 7	18.2 (9.72)
Lipase, Day 14	16.9 (14.65)

53. Secondary Outcome

Title	Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Amylase, Baseline, n= 16	53.6 (14.48)
Amylase, Day 3, n= 16	56.8 (19.32)
Amylase, Day 7, n= 15	52.7 (12.97)
Amylase, Day 9, n= 15	55.7 (13.39)
Lipase, Baseline, n= 16	16.9 (14.65)
Lipase, Day 3, n= 16	24.6 (34.82)
Lipase, Day 7, n= 15	17.5 (10.69)
Lipase, Day 9, n= 15	21.0 (14.16)

54. Secondary Outcome

Title	Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Creatinine, Day 7	5.69 (3.508)
Creatinine, Day 14	7.36 (4.833)
Total bilirubin, Day 7	2.25 (4.756)
Total bilirubin, Day 14	2.10 (5.109)
Direct bilirubin, Day 7	0.15 (0.634)
Direct bilirubin, Day 14	0.64 (0.699)

55. Secondary Outcome

Title	Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Creatinine, Day 3, n= 16	-2.34 (3.755)
Creatinine, Day 7, n= 15	3.53 (3.802)
Creatinine, Day 9, n= 15	0.28 (3.569)
Total bilirubin, Day 3, n= 16	-0.82 (3.475)
Total bilirubin, Day 7, n= 15	-0.26 (2.466)
Total bilirubin, Day 9, n= 15	-1.91 (2.252)
Direct bilirubin, Day 3, n= 16	-0.26 (0.534)
Direct bilirubin, Day 7, n= 15	-0.03 (0.547)
Direct bilirubin, Day 9, n= 15	-0.49 (0.501)

56. Secondary Outcome

Title	Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Creatinine, Baseline	80.16 (10.103)
Creatinine, Day 7	85.85 (9.586)
Creatinine, Day 14	87.52 (10.058)
Total bilirubin, Baseline	9.64 (6.143)
Total bilirubin, Day 7	11.89 (6.781)
Total bilirubin, Day 14	11.74 (7.046)
Direct bilirubin, Baseline	1.76 (1.016)
Direct bilirubin, Day 7	1.91 (0.752)
Direct bilirubin, Day 14	2.40 (1.035)

57. Secondary Outcome

Title	Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Creatinine, Baseline, n= 16	87.52 (10.058)
Creatinine, Day 3, n= 16	85.18 (10.314)
Creatinine, Day 7, n= 15	91.53 (9.504)
Creatinine, Day 9, n= 15	88.27 (9.916)
Total bilirubin, Baseline, n= 16	11.44 (6.022)
Total bilirubin, Day 3, n= 16	10.62 (7.886)
Total bilirubin, Day 7, n= 15	11.33 (5.487)
Total bilirubin, Day 9, n= 15	9.68 (4.603)
Direct bilirubin, Baseline, n= 16	2.40 (1.035)
Direct bilirubin, Day 3, n= 16	2.14 (1.065)
Direct bilirubin, Day 7, n= 15	2.41 (0.828)
Direct bilirubin, Day 9, n= 15	1.95 (0.673)

58. Secondary Outcome

Title	Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Total Protein, Day 7	2.6 (3.20)
Total Protein, Day 14	2.9 (2.66)
Globulin, Day 7	2.5 (1.37)
Globulin, Day 14	2.8 (1.91)
Albumin, Day 7	0.1 (2.22)
Albumin, Day 14	0.1 (2.05)

59. Secondary Outcome

Title	Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Total Protein, Day 3, n= 16	0.1 (2.68)
Total Protein, Day 7, n= 15	3.1 (2.85)
Total Protein, Day 9, n= 15	0.8 (3.28)
Globulin, Day 3, n= 16	0.2 (1.17)
Globulin, Day 7, n= 15	2.3 (0.96)
Globulin, Day 9, n= 15	0.2 (1.08)
Albumin, Day 3, n= 16	-0.1 (1.95)
Albumin, Day 7, n= 15	0.9 (2.20)
Albumin, Day 9, n= 15	0.6 (2.50)

60. Secondary Outcome

Title	Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Total Protein, Baseline	69.8 (3.64)
Total Protein, Day 7	72.4 (3.70)
Total Protein, Day 14	72.6 (3.10)
Globulin, Baseline	25.9 (2.50)
Globulin, Day 7	28.4 (2.60)
Globulin, Day 14	28.7 (1.99)
Albumin, Baseline	43.9 (2.36)
Albumin, Day 7	44.0 (1.90)
Albumin, Day 14	43.9 (2.41)

61. Secondary Outcome

Title	Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Description	Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Total Protein, Baseline, n= 16	72.6 (3.10)
Total Protein, Day 3, n= 16	72.8 (2.96)
Total Protein, Day 7, n= 15	75.7 (2.89)
Total Protein, Day 9, n= 15	73.3 (2.61)
Globulin, Baseline, n= 16	28.7 (1.99)
Globulin, Day 3, n= 16	28.9 (2.31)
Globulin, Day 7, n= 15	30.9 (1.96)
Globulin, Day 9, n= 15	28.8 (1.90)
Albumin, Baseline, n= 16	43.9 (2.41)
Albumin, Day 3, n= 16	43.9 (1.89)
Albumin, Day 7, n= 15	44.8 (2.08)
Albumin, Day 9, n= 15	44.5 (1.73)

62. Secondary Outcome

Title	Period 1: Change From Baseline in Specific Gravity of Urine
Description	Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Day 7	0.0007 (0.01085)
Day 14	0.0011 (0.00941)

63. Secondary Outcome

Title	Period 2: Change From Baseline in Specific Gravity of Urine
Description	Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Day 3, n= 16	0.0031 (0.00666)
Day 7, n= 15	0.0024 (0.00608)
Day 9, n= 15	0.0005 (0.00872)

64. Secondary Outcome

Title	Period 1: Absolute Values of Specific Gravity of Urine
Description	Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Baseline	1.0136 (0.01095)
Day 7	1.0143 (0.00556)
Day 14	1.0147 (0.00789)

65. Secondary Outcome

Title	Period 2: Absolute Values of Specific Gravity of Urine
Description	Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Baseline, n= 16	1.0147 (0.00789)
Day 3, n= 16	1.0178 (0.00584)
Day 7, n= 15	1.0170 (0.00655)
Day 9, n= 15	1.0151 (0.00788)

66. Secondary Outcome

Title	Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
Description	Urine samples were collected at indicated time points for the assessment of Urinary 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 Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Day 7	-0.34 (0.397)
Day 14	-0.19 (0.544)

67. Secondary Outcome

Title	Period 2: Change From Baseline in pH of Urine
Description	Urine samples were collected at indicated time points for the assessment of Urinary 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 Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Day 3, n= 16	0.19 (0.479)
Day 7, n= 15	0.10 (0.471)
Day 9, n= 15	0.10 (0.507)

68. Secondary Outcome

Title	Period 1: Absolute Values of pH of Urine
Description	Urine samples were collected at indicated time points for the assessment of Urinary 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 Day -1 for Period 1.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Baseline	6.22 (0.446)
Day 7	5.88 (0.289)
Day 14	6.03 (0.531)

69. Secondary Outcome

Title	Period 2: Absolute Values of pH of Urine
Description	Urine samples were collected at indicated time points for the assessment of Urinary 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 Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Baseline, n= 16	6.03 (0.531)
Day 3, n= 16	6.22 (0.482)
Day 7, n= 15	6.07 (0.320)
Day 9, n= 15	6.07 (0.320)

70. Secondary Outcome

Title	Period 1: Change From Baseline in Urine Urobilinogen
Description	Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Day 7	-2.5395 (5.45976)
Day 14	-2.5395 (5.45976)

71. Secondary Outcome

Title	Period 2: Change From Baseline in Urine Urobilinogen
Description	Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Day 3, n= 16	0.0000 (0.00000)
Day 7, n= 15	0.0000 (0.00000)
Day 9, n= 15	0.0000 (0.00000)

72. Secondary Outcome

Title	Period 1: Absolute Values of Urine Urobilinogen
Description	Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1.
Time Frame	Baseline and at Days 7, 14

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Baseline	5.9255 (5.45976)
Day 7	3.3860 (0.0000)
Day 14	3.3860 (0.0000)

73. Secondary Outcome

Title	Period 2: Absolute Values of Urine Urobilinogen
Description	Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2.
Time Frame	Baseline and at Days 3, 7, 9

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Baseline, n= 16	3.3860 (0.0000)
Day 3, n= 16	3.3860 (0.0000)
Day 7, n= 15	3.3860 (0.0000)
Day 9, n= 15	3.3860 (0.0000)

74. Secondary Outcome

Title	Period 1: Change From Baseline in Heart Rate
Description	Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Day 1, 2 and 4 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Day 1, 2 hours post-dose	1.5 (6.87)
Day 1, 4 hours post-dose	-3.3 (10.37)

75. Secondary Outcome

Title	Period 2: Change From Baseline in Heart Rate
Description	Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Day 1, 2 hours post-dose, n= 16	5.0 (4.37)
Day 1, 4 hours post-dose, n= 16	2.8 (6.62)
Day 4, Pre-dose, n= 15	-0.5 (11.10)
Day 4, 2 hours post-dose, n= 15	3.3 (5.86)
Day 4, 4 hours post-dose, n= 15	-0.3 (5.13)
Day 7, Pre-dose, n= 15	0.3 (11.18)
Day 7, 2 hours post-dose, n= 15	1.8 (6.72)
Day 7, 4 hours post-dose, n= 15	-2.3 (7.08)
Day 9 post-dose, n= 15	2.1 (7.84)

76. Secondary Outcome

Title	Period 1: Absolute Values of Heart Rate
Description	Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Day 1, 2 and 4 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Baseline	67.6 (8.72)
Day 1, 2 hours post-dose	69.1 (11.04)
Day 1, 4 hours post-dose	64.4 (11.87)

77. Secondary Outcome

Title	Period 2: Absolute Values of Heart Rate
Description	Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame	Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Baseline, n= 16	66.5 (8.06)
Day 1, 2 hours post-dose, n= 16	71.5 (9.95)
Day 1, 4 hours post-dose, n= 16	69.3 (11.38)
Day 4, Pre-dose, n= 15	65.1 (10.48)
Day 4, 2 hours post-dose, n= 15	68.9 (8.00)
Day 4, 4 hours post-dose, n= 15	65.3 (8.97)
Day 7, Pre-dose, n= 15	65.9 (10.25)
Day 7, 2 hours post-dose, n= 15	67.4 (6.39)
Day 7, 4 hours post-dose, n= 15	63.3 (8.31)
Day 9 post-dose, n= 15	67.7 (9.23)

78. Secondary Outcome

Title	Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval
Description	Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Day 1, 2 and 4 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
PR Interval, Day 1, 2 hours post-dose	1.5 (9.67)
PR Interval, Day 1, 4 hours post-dose	-1.9 (8.64)
QRS Duration, Day 1, 2 hours post-dose	-1.1 (3.68)
QRS Duration, Day 1, 4 hours post-dose	0.3 (4.96)
QT Interval, Day 1, 2 hours post-dose	-7.5 (14.12)
QT Interval, Day 1, 4 hours post-dose	5.8 (23.18)
QTcF Interval, Day 1, 2 hours post-dose	-4.9 (10.63)
QTcF Interval, Day 1, 4 hours post-dose	-1.3 (10.56)
QTcB Interval, Day 1, 2 hours post-dose	-4.1 (12.70)
QTcB Interval, Day 1, 4 hours post-dose	-5.4 (12.39)

79. Secondary Outcome

Title	Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
Description	Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
PR Interval, Day 1, 2 hours post-dose, n= 16	-6.8 (6.77)
PR Interval, Day 1, 4 hours post-dose, n= 16	-3.7 (5.99)
PR Interval, Day 4, Pre-dose, n= 15	-0.5 (4.56)
PR Interval, Day 4, 2 hours post-dose, n= 15	-6.9 (6.67)
PR Interval, Day 4, 4 hours post-dose, n= 15	-3.9 (7.83)
PR Interval, Day 7, Pre-dose, n= 15	-2.7 (8.57)
PR Interval, Day 7, 2 hours post-dose, n= 15	-3.3 (7.06)
PR Interval, Day 7, 4 hours post-dose, n= 15	-3.7 (8.53)
PR Interval, Day 9 post-dose, n= 15	1.2 (6.42)
QRS Duration, Day 1, 2 hours post-dose, n= 16	-2.5 (4.40)
QRS Duration, Day 1, 4 hours post-dose, n= 16	-1.4 (4.69)
QRS Duration, Day 4, Pre-dose, n= 15	0.5 (3.44)
QRS Duration, Day 4, 2 hours post-dose, n= 15	0.5 (5.72)
QRS Duration, Day 4, 4 hours post-dose, n= 15	-0.2 (2.70)
QRS Duration, Day 7, Pre-dose, n= 15	3.3 (4.53)
QRS Duration, Day 7, 2 hours post-dose, n= 15	1.5 (5.15)
QRS Duration, Day 7, 4 hours post-dose, n= 15	0.3 (3.72)
QRS Duration, Day 9 post-dose, n= 15	3.0 (5.36)
QT Interval, Day 1, 2 hours post-dose, n= 16	-12.6 (9.11)
QT Interval, Day 1, 4 hours post-dose, n= 16	-1.8 (14.72)
QT Interval, Day 4, Pre-dose, n= 15	7.3 (18.27)
QT Interval, Day 4, 2 hours post-dose, n= 15	-6.8 (15.72)
QT Interval, Day 4, 4 hours post-dose, n= 15	5.6 (14.64)
QT Interval, Day 7, Pre-dose, n= 15	3.5 (18.31)
QT Interval, Day 7, 2 hours post-dose, n= 15	-8.4 (16.15)
QT Interval, Day 7, 4 hours post-dose, n= 15	5.8 (17.37)
QT Interval, Day 9 post-dose, n= 15	4.1 (16.46)
QTcF Interval, Day 1, 2 hours post-dose, n= 16	-4.4 (7.29)
QTcF Interval, Day 1, 4 hours post-dose, n= 16	2.4 (7.77)
QTcF Interval, Day 4, Pre-dose, n= 15	6.1 (11.17)
QTcF Interval, Day 4, 2 hours post-dose, n= 15	-0.6 (10.91)
QTcF Interval, Day 4, 4 hours post-dose, n= 15	4.5 (8.22)
QTcF Interval, Day 7, Pre-dose, n= 15	4.1 (8.71)
QTcF Interval, Day 7, 2 hours post-dose, n= 15	-5.1 (9.34)
QTcF Interval, Day 7, 4 hours post-dose, n= 15	0.6 (9.03)
QTcF Interval, Day 9 post-dose, n= 15	7.9 (8.53)
QTcB Interval, Day 1, 2 hours post-dose, n= 16	0.7 (8.83)
QTcB Interval, Day 1, 4 hours post-dose, n= 16	4.7 (8.49)
QTcB Interval, Day 4, Pre-dose, n= 15	5.5 (18.50)
QTcB Interval, Day 4, 2 hours post-dose, n= 15	2.5 (12.37)
QTcB Interval, Day 4, 4 hours post-dose, n= 15	4.3 (8.52)
QTcB Interval, Day 7, Pre-dose, n= 15	4.6 (16.31)
QTcB Interval, Day 7, 2 hours post-dose, n= 15	-3.2 (11.64)
QTcB Interval, Day 7, 4 hours post-dose, n= 15	-1.7 (12.06)
QTcB Interval, Day 9 post-dose, n= 15	10.3 (12.19)

80. Secondary Outcome

Title	Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
Description	Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame	Baseline and at Day 1, 2 and 4 hours post-dose

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
PR Interval, Baseline	161.3 (16.53)
PR Interval, Day 1, 2 hours post-dose	162.8 (19.01)
PR Interval, Day 1, 4 hours post-dose	159.4 (19.47)
QRS Duration, Baseline	91.0 (8.22)
QRS Duration, Day 1, 2 hours post-dose	89.9 (7.54)
QRS Duration, Day 1, 4 hours post-dose	91.3 (8.14)
QT Interval, Baseline	377.8 (24.84)
QT Interval, Day 1, 2 hours post-dose	370.3 (24.74)
QT Interval, Day 1, 4 hours post-dose	383.6 (32.12)
QTcF Interval, Baseline	391.6 (12.92)
QTcF Interval, Day 1, 2 hours post-dose	386.7 (14.33)
QTcF Interval, Day 1, 4 hours post-dose	390.3 (18.27)
QTcB Interval, Baseline	398.8 (11.28)
QTcB Interval, Day 1, 2 hours post-dose	394.6 (15.14)
QTcB Interval, Day 1, 4 hours post-dose	393.3 (18.26)

81. Secondary Outcome

Title	Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
Description	Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame	Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
PR Interval, Baseline, n= 16	167.3 (19.46)
PR Interval, Day 1, 2 hours post-dose, n= 16	160.4 (19.73)
PR Interval, Day 1, 4 hours post-dose, n= 16	163.6 (19.04)
PR Interval, Day 4, Pre-dose, n= 15	167.1 (22.20)
PR Interval, Day 4, 2 hours post-dose, n= 15	160.7 (19.59)
PR Interval, Day 4, 4 hours post-dose, n= 15	163.7 (19.29)
PR Interval, Day 7, Pre-dose, n= 15	164.9 (21.11)
PR Interval, Day 7, 2 hours post-dose, n= 15	164.3 (20.95)
PR Interval, Day 7, 4 hours post-dose, n= 15	163.9 (22.05)
PR Interval, Day 9 post-dose, n= 15	168.8 (23.70)
QRS Duration, Baseline, n= 16	91.4 (7.87)
QRS Duration, Day 1, 2 hours post-dose, n= 16	88.9 (8.20)
QRS Duration, Day 1, 4 hours post-dose, n= 16	90.1 (7.66)
QRS Duration, Day 4, Pre-dose, n= 15	91.8 (8.37)
QRS Duration, Day 4, 2 hours post-dose, n= 15	91.8 (9.12)
QRS Duration, Day 4, 4 hours post-dose, n= 15	91.1 (8.51)
QRS Duration, Day 7, Pre-dose, n= 15	94.5 (8.25)
QRS Duration, Day 7, 2 hours post-dose, n= 15	92.7 (7.49)
QRS Duration, Day 7, 4 hours post-dose, n= 15	91.6 (7.23)
QRS Duration, Day 9 post-dose, n= 15	94.3 (8.17)
QT Interval, Baseline, n= 16	377.7 (22.66)
QT Interval, Day 1, 2 hours post-dose, n= 16	365.1 (23.71)
QT Interval, Day 1, 4 hours post-dose, n= 16	375.9 (30.14)
QT Interval, Day 4, Pre-dose, n= 15	385.6 (26.65)
QT Interval, Day 4, 2 hours post-dose, n= 15	371.5 (27.31)
QT Interval, Day 4, 4 hours post-dose, n= 15	383.9 (31.05)
QT Interval, Day 7, Pre-dose, n= 15	381.7 (22.25)
QT Interval, Day 7, 2 hours post-dose, n= 15	369.9 (25.66)
QT Interval, Day 7, 4 hours post-dose, n= 15	384.1 (30.53)
QT Interval, Day 9 post-dose, n= 15	382.4 (26.55)
QTcF Interval, Baseline, n= 16	390.0 (13.48)
QTcF Interval, Day 1, 2 hours, n= 16	385.6 (15.44)
QTcF Interval, Day 1, 4 hours post-dose, n= 16	392.4 (15.95)
QTcF Interval, Day 4, Pre-dose, n= 15	395.0 (21.88)
QTcF Interval, Day 4, 2 hours post-dose, n= 15	388.3 (17.56)
QTcF Interval, Day 4, 4 hours post-dose, n= 15	393.4 (18.97)
QTcF Interval, Day 7, Pre-dose, n= 15	393.0 (18.42)
QTcF Interval, Day 7, 2 hours post-dose, n= 15	383.8 (16.19)
QTcF Interval, Day 7, 4 hours post-dose, n= 15	389.5 (18.06)
QTcF Interval, Day 9 post-dose, n= 15	396.8 (18.51)
QTcB Interval, Baseline, n= 16	395.7 (14.19)
QTcB Interval, Day 1, 2 hours post-dose, n= 16	396.4 (17.29)
QTcB Interval, Day 1, 4 hours post-dose, n= 16	400.4 (16.20)
QTcB Interval, Day 4, Pre-dose, n= 15	399.2 (25.96)
QTcB Interval, Day 4, 2 hours post-dose, n= 15	396.2 (16.01)
QTcB Interval, Day 4, 4 hours post-dose, n= 15	398.0 (17.53)
QTcB Interval, Day 7, Pre-dose, n= 15	398.3 (23.83)
QTcB Interval, Day 7, 2 hours post-dose, n= 15	390.5 (13.31)
QTcB Interval, Day 7, 4 hours post-dose, n= 15	391.9 (16.35)
QTcB Interval, Day 9 post-dose, n= 15	404.0 (20.62)

82. Secondary Outcome

Title	Period 1: Change From Baseline in Temperature
Description	Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 2, 3, 4, 5 and 7

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Day 2	-0.16 (0.400)
Day 3	-0.15 (0.576)
Day 4	-0.09 (0.406)
Day 5	-0.15 (0.371)
Day 7	-0.24 (0.491)

83. Secondary Outcome

Title	Period 2: Change From Baseline in Temperature
Description	Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 4, 7, 9, and 10

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Day 4	-0.10 (0.344)
Day 7	-0.07 (0.337)
Day 9	-0.01 (0.386)
Day 10	0.07 (0.320)

84. Secondary Outcome

Title	Period 1: Absolute Values of Temperature
Description	Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame	Baseline and at Days 2, 3, 4, 5 and 7

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Baseline	36.49 (0.298)
Day 2	36.33 (0.342)
Day 3	36.34 (0.456)
Day 4	36.41 (0.431)
Day 5	36.34 (0.360)
Day 7	36.25 (0.407)

85. Secondary Outcome

Title	Period 2: Absolute Values of Temperature
Description	Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame	Baseline and at Days 4, 7, 9, and 10

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Baseline, n= 16	36.49 (0.257)
Day 4, n=15	36.37 (0.348)
Day 7, n=15	36.40 (0.421)
Day 9, n=15	36.46 (0.378)
Day 10, n=15	36.53 (0.282)

86. Secondary Outcome

Title	Period 1: Change From Baseline in Pulse Rate
Description	Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 2, 3, 4, 5 and 7

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Day 2	-1.2 (9.77)
Day 3	-3.8 (9.94)
Day 4	-4.0 (9.67)
Day 5	-1.6 (10.47)
Day 7	-7.6 (7.83)

87. Secondary Outcome

Title	Period 2: Change From Baseline in Pulse Rate
Description	Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 4, 7, 9, and 10

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Day 4	2.4 (18.62)
Day 7	1.9 (15.62)
Day 9	-0.3 (10.20)
Day 10	9.5 (11.12)

88. Secondary Outcome

Title	Period 1: Absolute Values of Pulse Rate
Description	Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame	Baseline and at Days 2, 3, 4, 5 and 7

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Baseline	73.9 (9.24)
Day 2	72.8 (10.14)
Day 3	70.1 (11.18)
Day 4	69.9 (10.81)
Day 5	72.3 (12.38)
Day 7	66.3 (10.20)

89. Secondary Outcome

Title	Period 2: Absolute Values of Pulse Rate
Description	Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame	Baseline and at Days 4, 7, 9, and 10

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Baseline, n= 16	70.5 (11.33)
Day 4, n=15	71.9 (18.39)
Day 7, n=15	71.4 (14.73)
Day 9, n=15	69.2 (10.73)
Day 10, n=15	79.0 (12.45)

90. Secondary Outcome

Title	Period 1: Change From Baseline in Respiratory Rate
Description	Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 2, 3, 4, 5 and 7

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Day 2	-1.5 (2.00)
Day 3	-0.5 (3.14)
Day 4	-0.5 (2.37)
Day 5	1.3 (2.52)
Day 7	0.6 (3.24)

91. Secondary Outcome

Title	Period 2: Change From Baseline in Respiratory Rate
Description	Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 4, 7, 9, and 10

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Day 4	-3.2 (3.61)
Day 7	-2.4 (2.85)
Day 9	-0.8 (2.11)
Day 10	-1.5 (2.33)

92. Secondary Outcome

Title	Period 1: Absolute Values of Respiratory Rate
Description	Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame	Baseline and at Days 2, 3, 4, 5 and 7

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Baseline	14.0 (1.63)
Day 2	12.5 (1.37)
Day 3	13.5 (2.48)
Day 4	13.5 (2.00)
Day 5	15.3 (2.05)
Day 7	14.6 (2.70)

93. Secondary Outcome

Title	Period 2: Absolute Values of Respiratory Rate
Description	Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame	Baseline and at Days 4, 7, 9, and 10

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
Baseline, n= 16	15.6 (2.22)
Day 4, n=15	12.5 (2.67)
Day 7, n=15	13.3 (2.35)
Day 9, n=15	14.9 (1.49)
Day 10, n=15	14.3 (1.49)

94. Secondary Outcome

Title	Period 1: Change From Baseline in Blood Pressure
Description	Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 2, 3, 4, 5 and 7

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
SBP, Day 2	1.4 (8.96)
SBP, Day 3	-1.8 (8.54)
SBP, Day 4	-2.7 (6.16)
SBP, Day 5	-2.3 (8.81)
SBP, Day 7	0.8 (9.47)
DBP, Day 2	0.1 (8.33)
DBP, Day 3	-1.6 (7.20)
DBP, Day 4	0.1 (7.89)
DBP, Day 5	-1.4 (6.20)
DBP, Day 7	2.9 (7.58)

95. Secondary Outcome

Title	Period 2: Change From Baseline in Blood Pressure
Description	SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline and at Days 4, 7, 9, and 10

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
SBP, Day 4	-0.3 (5.07)
SBP, Day 7	1.1 (8.95)
SBP, Day 9	-1.7 (6.91)
SBP, Day 10	4.1 (7.79)
DBP, Day 4	0.1 (4.96)
DBP, Day 7	3.7 (5.70)
DBP, Day 9	-4.0 (5.26)
DBP, Day 10	-2.1 (8.18)

96. Secondary Outcome

Title	Period 1: Absolute Values of Blood Pressure
Description	SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame	Baseline and at Days 2, 3, 4, 5 and 7

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
SBP, Baseline	123.3 (8.27)
SBP, Day 2	124.7 (9.60)
SBP, Day 3	121.5 (7.70)
SBP, Day 4	120.6 (8.47)
SBP, Day 5	121.0 (6.95)
SBP, Day 7	124.1 (10.56)
DBP, Baseline	75.3 (5.22)
DBP, Day 2	75.4 (9.08)
DBP, Day 3	73.8 (5.69)
DBP, Day 4	75.4 (10.42)
DBP, Day 5	73.9 (5.46)
DBP, Day 7	78.2 (7.57)

97. Secondary Outcome

Title	Period 2: Absolute Values of Blood Pressure
Description	SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.
Time Frame	Baseline and at Days 4, 7, 9, and 10

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	16
SBP, Baseline, n= 16	120.4 (7.27)
SBP, Day 4, n=15	119.3 (7.03)
SBP, Day 7, n=15	120.8 (10.58)
SBP, Day 9, n=15	117.9 (7.42)
SBP, Day 10, n=15	123.7 (8.52)
DBP, Baseline, n= 16	74.4 (6.14)
DBP, Day 4, n= 15	74.3 (5.16)
DBP, Day 7, n= 15	77.9 (8.98)
DBP, Day 9, n= 15	70.3 (7.36)
DBP, Day 10, n= 15	72.1 (6.41)

98. Secondary Outcome

Title	Period 2: AUC (0-tau) of GSK3640254
Description	Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Geometric Mean (Geometric Coefficient of Variation) [Hours*nanogram per milliliter]	24.53 (26.5)

99. Secondary Outcome

Title	Period 2: Cmax of GSK3640254
Description	Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	1.411 (26.4)

100. Secondary Outcome

Title	Period 2: Ctau of GSK3640254
Description	Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 1 and 2 hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Geometric Mean (Geometric Coefficient of Variation) [Nanogram per milliliter]	0.7883 (30.3)

101. Secondary Outcome

Title	Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254
Description	Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Median (Full Range) [Hours]	5.000

102. Secondary Outcome

Title	Period 1: Tmax of TAF
Description	Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Median (Full Range) [Hours]	1.00

103. Secondary Outcome

Title	Period 2: Tmax of TAF
Description	Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Median (Full Range) [Hours]	1.000

104. Secondary Outcome

Title	Period 1: Tmax of FTC
Description	Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Median (Full Range) [Hours]	1.500

105. Secondary Outcome

Title	Period 2: Tmax of FTC
Description	Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Median (Full Range) [Hours]	1.500

106. Secondary Outcome

Title	Period 1: Tmax of TFV
Description	Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.
Measure Participants	16
Median (Full Range) [Hours]	3.000

107. Secondary Outcome

Title	Period 2: Tmax of TFV
Description	Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.
Time Frame	Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7

Outcome Measure Data

Analysis Population Description

PK Parameter Population

Arm/Group Title	TAF/FTC+GSK3640254
Arm/Group Description	In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
Measure Participants	15
Median (Full Range) [Hours]	3.000

Adverse Events

Time Frame	Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Adverse Event Reporting Description	Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
Arm/Group Title	TAF/FTC		TAF/FTC+GSK3640254
Arm/Group Description	Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods.		In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods.
All Cause Mortality
	TAF/FTC		TAF/FTC+GSK3640254
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)
Serious Adverse Events
	TAF/FTC		TAF/FTC+GSK3640254
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	TAF/FTC		TAF/FTC+GSK3640254
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/16 (56.3%)		3/16 (18.8%)
Blood and lymphatic system disorders
Lymphadenopathy	1/16 (6.3%)	1	0/16 (0%)	0
Gastrointestinal disorders
Nausea	2/16 (12.5%)	2	0/16 (0%)	0
Abdominal discomfort	1/16 (6.3%)	1	0/16 (0%)	0
Vomiting	1/16 (6.3%)	2	0/16 (0%)	0
Immune system disorders
Seasonal allergy	1/16 (6.3%)	1	0/16 (0%)	0
Infections and infestations
Upper respiratory tract infection	3/16 (18.8%)	3	0/16 (0%)	0
Rash pustular	2/16 (12.5%)	2	0/16 (0%)	0
Conjunctivitis	1/16 (6.3%)	1	0/16 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	1/16 (6.3%)	1	0/16 (0%)	0
Muscular weakness	1/16 (6.3%)	1	0/16 (0%)	0
Nervous system disorders
Headache	1/16 (6.3%)	1	0/16 (0%)	0
Somnolence	0/16 (0%)	0	1/16 (6.3%)	1
Psychiatric disorders
Abnormal dreams	1/16 (6.3%)	1	0/16 (0%)	0
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic	1/16 (6.3%)	1	1/16 (6.3%)	1
Skin and subcutaneous tissue disorders
Ingrown hair	1/16 (6.3%)	1	0/16 (0%)	0
Urticaria	0/16 (0%)	0	1/16 (6.3%)	1

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.