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A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants

Sponsor
ViiV Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT04263142
Collaborator
(none)
39
Enrollment
1
Location
5
Arms
1.9
Actual Duration (Months)
20.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, 2 part, single-dose and crossover study conducted to assess the relative bioavailability of a tablet compared to a capsule of GSK3640254 and to assess the effect of food on the GSK3640254 tablet in healthy participants. This study will also evaluate the effect of food (fasted, moderate fat meal, and high fat meal) on the pharmacokinetics of the GSK3640254 mesylate tablet formulation. In Part 1, participants will be randomly assigned to 1 of 2 treatment sequences (AB or BA) in two sequential treatment periods; and in Part 2, participants will be randomly assigned to 1 of 3 treatment sequences (CDE, DEC, or ECD) in three sequential treatment periods. Participants will be randomized to receive a single dose of GSK3640254 200 milligram (mg) capsules under moderate fat conditions and GSK3640254 200 mg tablets under moderate fat, fasted and high fat conditions in each treatment period. Approximately 30 participants will be enrolled.

Condition or Disease Intervention/Treatment Phase
  • Drug: GSK3640254 Tablet
  • Drug: GSK3640254 Capsule
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Eligible participants will be randomly assigned to 1 of 2 treatment sequences (AB or BA) in Part 1 and 1 of 3 treatment sequences (CDE, DEC, or ECD) in Part 2.Eligible participants will be randomly assigned to 1 of 2 treatment sequences (AB or BA) in Part 1 and 1 of 3 treatment sequences (CDE, DEC, or ECD) in Part 2.
Masking:
None (Open Label)
Masking Description:
This is an open label study.
Primary Purpose:
Treatment
Official Title:
A Two-Part, Randomized, Open-Label, Single Dose, Crossover Clinical Trial to Assess the Relative Bioavailability of a Tablet Compared to a Capsule of GSK3640254 and to Assess the Effect of Food on the GSK3640254 Tablet in Healthy Participants
Actual Study Start Date :
Jan 27, 2020
Actual Primary Completion Date :
Mar 24, 2020
Actual Study Completion Date :
Mar 24, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: Treatment AB

Participants will receive a single dose of GSK3640254 200 mg (Treatment A- Reference), capsules, orally under moderate fat conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment B- Test), tablets, orally under moderate fat conditions on Day 1 in second intervention period. There will be at least 7 days wash out period between each dose of study intervention.

Drug: GSK3640254 Tablet
GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.

Drug: GSK3640254 Capsule
GSK3640254 capsules will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
Experimental: Part 1: Treatment BA

Participants will receive a single dose of GSK3640254 200 mg (Treatment B- Test), tablets, orally under moderate fat conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment A- Reference), capsules, orally under moderate fat conditions on Day 1 in second intervention period. There will be at least 7 days wash out period between each dose of study intervention.

Drug: GSK3640254 Tablet
GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.

Drug: GSK3640254 Capsule
GSK3640254 capsules will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
Experimental: Part 2: Treatment CDE

Participants will receive a single dose of GSK3640254 200 mg (Treatment C- Test), tablets, orally under moderate fat conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment D- Reference), tablets, orally under fasted conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment E- Test), tablets, orally under high fat conditions on Day 1 in third intervention period. There will be at least 7 days wash out period between each dose of study intervention.

Drug: GSK3640254 Tablet
GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
Experimental: Part 2: Treatment DEC

Participants will receive a single dose of GSK3640254 200 mg (Treatment D- Reference), tablets, orally under fasted conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment E- Test), tablets, orally under high fat conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment C- Test), tablets, orally under moderate fat conditions on Day 1 in third intervention period. There will be at least 7 days wash out period between each dose of study intervention.

Drug: GSK3640254 Tablet
GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
Experimental: Part 2: Treatment ECD

Participants will receive a single dose of GSK3640254 200 mg (Treatment E- Test), tablets, orally under high fat conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment C- Test), tablets, orally under moderate fat conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment D- Reference), tablets, orally under fasted conditions on Day 1 in third intervention period. There will be at least 7 days wash out period between each dose of study intervention.

Drug: GSK3640254 Tablet
GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.

Outcome Measures

Primary Outcome Measures

  1. Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) for GSK3640254-Part 1 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were calculated using standard non-compartmental analysis.

  2. Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Time t (AUC[0 to t]) for GSK3640254-Part 1 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  3. Maximum Observed Concentration (Cmax) for GSK3640254-Part 1 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  4. Time of Maximum Observed Concentration for GSK3640254-Part 1 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  5. AUC(0 to Inf) for GSK3640254-Part 2 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  6. AUC(0 to t) for GSK3640254-Part 2 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  7. Cmax for GSK3640254-Part 2 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  8. Time of Maximum Observed Concentration for GSK3640254-Part 2 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

Secondary Outcome Measures

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 [Up to Day 12]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is 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 or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

  2. Number of Participants With AEs and SAEs-Part 2 [Up to Day 19]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is 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 or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

  3. Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets.

  4. Absolute Values for Erythrocytes Count-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: erythrocytes count.

  5. Absolute Values for Hemoglobin-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: hemoglobin.

  6. Absolute Values for Hematocrit-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: hematocrit.

  7. Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume.

  8. Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin.

  9. Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets.

  10. Absolute Values for Erythrocytes Count-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: erythrocytes count.

  11. Absolute Values for Hemoglobin-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: hemoglobin.

  12. Absolute Values for Hematocrit-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: hematocrit.

  13. Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume.

  14. Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin.

  15. Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  16. Change From Baseline in Erythrocytes Count-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  17. Change From Baseline in Hemoglobin-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  18. Change From Baseline in Hematocrit-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  19. Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  20. Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  21. Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  22. Change From Baseline in Erythrocytes Count-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  23. Change From Baseline in Hemoglobin-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  24. Change From Baseline in Hematocrit-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  25. Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  26. Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  27. Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate.

  28. Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide.

  29. Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH.

  30. Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein.

  31. Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase.

  32. Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate.

  33. Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide.

  34. Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH.

  35. Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein.

  36. Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase.

  37. Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  38. Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  39. Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  40. Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  41. Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  42. Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  43. Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  44. Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  45. Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  46. Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  47. Absolute Values for Urine Parameter: Specific Gravity-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    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, indicated as ratio of urine density to water density.

  48. Absolute Values for Urine Parameter: Urobilinogen-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen.

  49. Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0).

  50. Absolute Values for Urine Parameter: Specific Gravity-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    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, indicated as ratio of urine density to water density.

  51. Absolute Values for Urine Parameter: Urobilinogen-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen.

  52. Absolute Values for Urine Parameter: pH-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0).

  53. Change From Baseline in Urine Parameter: Specific Gravity-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    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, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  54. Change From Baseline in Urine Parameter: Urobilinogen-Part 1 [Baseline (Day -1), Day 2 and Day 5]

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  55. Change From Baseline in Urine Parameter: pH-Part 1 [Baseline (Day -1), Day 2 and Day 5]

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

  56. Change From Baseline in Urine Parameter: Specific Gravity-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    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, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  57. Change From Baseline in Urine Parameter: Urobilinogen-Part 2 [Baseline (Day -1), Day 2 and Day 5]

    Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  58. Change From Baseline in Urine Parameter: pH-Part 2 [Baseline (Day -1), Day 2 and Day 5]

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

  59. Number of Participants With Abnormal Urine Dipstick Results-Part 1 [Day 2 and Day 5]

    Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented.

  60. Number of Participants With Abnormal Urine Dipstick Results-Part 2 [Day 2 and Day 5]

    Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented.

  61. Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1 [Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5]

    Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals.

  62. Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 [Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5]

    Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals.

  63. Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1 [Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5]

    Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  64. Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2 [Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5]

    Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  65. Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  66. Absolute Values for Vital Sign: Pulse Rate-Part 1 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  67. Absolute Values for Vital Sign: Respiratory Rate-Part 1 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  68. Absolute Values for Vital Sign: Temperature-Part 1 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  69. Absolute Values for Vital Signs: DBP and SBP-Part 2 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  70. Absolute Values for Vital Sign: Pulse Rate-Part 2 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  71. Absolute Values for Vital Sign: Respiratory Rate-Part 2 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  72. Absolute Values for Vital Sign: Temperature-Part 2 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  73. Change From Baseline in Vital Signs: SBP and DBP-Part 1 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  74. Change From Baseline in Vital Sign: Pulse Rate-Part 1 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

  75. Change From Baseline in Vital Sign: Respiratory Rate-Part 1 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  76. Change From Baseline in Vital Sign: Temperature-Part 1 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  77. Change From Baseline in Vital Signs: SBP and DBP-Part 2 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  78. Change From Baseline in Vital Sign: Pulse Rate-Part 2 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  79. Change From Baseline in Vital Sign: Respiratory Rate-Part 2 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  80. Change From Baseline in Vital Sign: Temperature-Part 2 [Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5]

    Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.

  81. Lag Time for Absorption (Tlag) for GSK3640254-Part 1 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  82. Apparent Terminal Phase Half-life (t1/2) for GSK3640254-Part 1 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  83. Apparent Oral Clearance (CL/F) for GSK3640254-Part 1 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  84. Apparent Volume of Distribution (Vz/F) for GSK3640254-Part 1 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  85. Plasma Concentration of GSK3640254-Part 1 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

    Blood samples were collected at indicated time points for PK analysis.

  86. Tlag for GSK3640254-Part 2 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  87. T1/2 for GSK3640254-Part 2 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  88. CL/F for GSK3640254-Part 2 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  89. Vz/F for GSK3640254-Part 2 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

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

  90. Plasma Concentration of GSK3640254-Part 2 [pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose]

    Blood samples were collected at indicated time points for PK analysis.

Eligibility Criteria

Criteria

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

Inclusion Criteria

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

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

  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants: Males shall not engage in intercourse while confined in the clinic. There is no need for an extended period of double barrier use or prolonged abstinence after study discharge. Female participants: 1. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: a. not a woman of childbearing potential (WOCBP); or Is a WOCBP and using a nonhormonal contraceptive method that is highly effective, with a failure rate of <1 percent (%), for 28 days before intervention, during the intervention period, and for at least 28 days after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. 2. A WOCBP must have a negative highly sensitive serum pregnancy test at Screening and Day -1. 3. Additional requirements for pregnancy testing during and after study intervention.

  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions.

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 (example [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 intervention or render the participant unable to take oral study intervention.

  • Prior cholecystectomy surgery (prior appendectomy is acceptable).

  • 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. Participants 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 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 participant's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the participant.

  • Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome.

  • Presence of hepatitis B surface antigen 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 Human immunodeficiency virus (HIV)-1 and -2 antigen/antibody immunoassay at Screening.

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

  • Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat of any laboratory abnormality is allowed within a single Screening period to determine eligibility.

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

  • Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT (described above), will exclude a participant 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 nonprescription drugs including vitamins, herbal and dietary supplements (including Saint 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 intervention and for the duration of the study.

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

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

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

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

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

  • Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the past 3 months, symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia, second-degree atrioventricular block Mobitz Type II, third-degree atrioventricular block, complete heart block, or conduction abnormality) which, in the opinion of the investigator or Medical Monitor, will interfere with the safety for the individual participant.

  • Exclusion criteria for Screening ECG (a single repeat is allowed for eligibility determination): Heart rate: <50 or >100 beats per minute and QTcF interval: >450 millisecond.

  • 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 (approximately 240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits.

  • Unable to refrain from 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)

More Information

Publications

None provided.
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT04263142
Other Study ID Numbers:
  • 213567
First Posted:
Feb 10, 2020
Last Update Posted:
Mar 3, 2021
Last Verified:
Feb 1, 2021
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
Healthy participants
GSK3640254
Human immunodeficiency virus
Relative Bioavailability
Additional relevant MeSH terms:
HIV Infections

Study Results

Participant Flow

Recruitment Details This was a 2-part, randomized, single dose cross-over study conducted at a single center in the United States to assess the relative bioavailability and food effect of GSK3640254 tablet and capsule formulations in healthy participants.
Pre-assignment Detail A total of 39 participants were enrolled in Part 1 (18 participants) and Part 2 (21 participants) of the study.
Arm/Group Title Part 1: Treatment Sequence AB Part 1: Treatment Sequence BA Part 2: Treatment Sequence CDE Part 2: Treatment Sequence DEC Part 2: Treatment Sequence ECD
Arm/Group Description Participants were administered a single dose of GSK3640254 200 milligram (mg) capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg tablets (Treatment B- test), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention. Participants were administered a single dose of GSK3640254 200 mg tablets (Treatment B-test), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 1; followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 2; followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
Period Title: Part 1 Period 1 (Day 1)
STARTED 9 9 0 0 0
COMPLETED 9 9 0 0 0
NOT COMPLETED 0 0 0 0 0
Period Title: Part 1 Period 1 (Day 1)
STARTED 9 9 0 0 0
COMPLETED 9 9 0 0 0
NOT COMPLETED 0 0 0 0 0
Period Title: Part 1 Period 1 (Day 1)
STARTED 0 0 7 7 7
COMPLETED 0 0 7 7 6
NOT COMPLETED 0 0 0 0 1
Period Title: Part 1 Period 1 (Day 1)
STARTED 0 0 7 7 6
COMPLETED 0 0 7 7 5
NOT COMPLETED 0 0 0 0 1
Period Title: Part 1 Period 1 (Day 1)
STARTED 0 0 7 7 5
COMPLETED 0 0 7 7 5
NOT COMPLETED 0 0 0 0 0

Baseline Characteristics

Arm/Group Title Part 1: Treatment Sequence AB Part 1: Treatment Sequence BA Part 2: Treatment Sequence CDE Part 2: Treatment Sequence DEC Part 2: Treatment Sequence ECD Total
Arm/Group Description Participants were administered a single dose of GSK3640254 200 milligram (mg) capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg tablets (Treatment B- test), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention. Participants were administered a single dose of GSK3640254 200 mg tablets (Treatment B-test), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 1; followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 2; followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention. Total of all reporting groups
Overall Participants 9 9 7 7 7 39
Age, Customized (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
19 to 64 years
9
100%
9
100%
7
100%
7
100%
7
100%
39
100%
>=65 years
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Sex: Female, Male (Count of Participants)
Female
2
22.2%
3
33.3%
3
42.9%
1
14.3%
5
71.4%
14
35.9%
Male
7
77.8%
6
66.7%
4
57.1%
6
85.7%
2
28.6%
25
64.1%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaskan Native
1
11.1%
0
0%
0
0%
0
0%
0
0%
1
2.6%
Black or African American
4
44.4%
2
22.2%
3
42.9%
2
28.6%
4
57.1%
15
38.5%
Native Hawaiian or Other Pacific Islander
0
0%
1
11.1%
0
0%
0
0%
0
0%
1
2.6%
White-Arabic/North African Heritage
0
0%
1
11.1%
0
0%
0
0%
0
0%
1
2.6%
White-White/Caucasian/European Heritage
4
44.4%
5
55.6%
4
57.1%
5
71.4%
3
42.9%
21
53.8%

Outcome Measures

1. Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) for GSK3640254-Part 1
Description Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were calculated using standard non-compartmental analysis.
Time Frame pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description
PK Parameter Population comprised of all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]
36.94
(42.7)
36.88
(40.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: GSK3640254 200 mg Capsules, Part 1: GSK3640254 200 mg Tablets
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.998
Confidence Interval (2-Sided) 90%
0.9263 to 1.0757
Parameter Dispersion Type:
Value:
Estimation Comments Analysis was performed using analysis of variance (ANOVA) with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablets/capsules.
2. Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Time t (AUC[0 to t]) for GSK3640254-Part 1
Description Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time Frame pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description
PK Parameter Population
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Geometric Mean (Geometric Coefficient of Variation) [Hours*microgram per milliliter]
33.72
(41.1)
33.80
(40.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: GSK3640254 200 mg Capsules, Part 1: GSK3640254 200 mg Tablets
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.002
Confidence Interval (2-Sided) 90%
0.9321 to 1.0781
Parameter Dispersion Type:
Value:
Estimation Comments Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablets/capsules.
3. Primary Outcome
Title Maximum Observed Concentration (Cmax) for GSK3640254-Part 1
Description Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time Frame pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description
PK Parameter Population
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter]
1.201
(33.4)
1.313
(45.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: GSK3640254 200 mg Capsules, Part 1: GSK3640254 200 mg Tablets
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.093
Confidence Interval (2-Sided) 90%
0.9885 to 1.2080
Parameter Dispersion Type:
Value:
Estimation Comments Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablets/capsules.
4. Primary Outcome
Title Time of Maximum Observed Concentration for GSK3640254-Part 1
Description Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time Frame pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description
PK Parameter Population
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Median (Full Range) [Hours]
5.000
4.000
5. Primary Outcome
Title AUC(0 to Inf) for GSK3640254-Part 2
Description Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time Frame pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description
PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 10 21
Geometric Mean (Geometric Coefficient of Variation) [Hours*micrograms per milliliter]
41.00
(42.2)
13.46
(58.2)
36.92
(35.9)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: GSK3640254 200 mg Capsules, Part 1: GSK3640254 200 mg Tablets
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 2.926
Confidence Interval (2-Sided) 90%
2.3703 to 3.6107
Parameter Dispersion Type:
Value:
Estimation Comments Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: GSK3640254 200 mg Tablets, Part 2: GSK3640254 200 mg Tablet (High Fat)
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 2.594
Confidence Interval (2-Sided) 90%
2.1003 to 3.2038
Parameter Dispersion Type:
Value:
Estimation Comments Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)
6. Primary Outcome
Title AUC(0 to t) for GSK3640254-Part 2
Description Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time Frame pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description
PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 13 21
Geometric Mean (Geometric Coefficient of Variation) [Hours*micrograms per milliliter]
37.91
(41.5)
11.37
(65.6)
34.08
(34.9)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: GSK3640254 200 mg Capsules, Part 1: GSK3640254 200 mg Tablets
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 3.146
Confidence Interval (2-Sided) 90%
2.5925 to 3.8178
Parameter Dispersion Type:
Value:
Estimation Comments Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: GSK3640254 200 mg Tablets, Part 2: GSK3640254 200 mg Tablet (High Fat)
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 2.785
Confidence Interval (2-Sided) 90%
2.2943 to 3.3807
Parameter Dispersion Type:
Value:
Estimation Comments Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)
7. Primary Outcome
Title Cmax for GSK3640254-Part 2
Description Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time Frame pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description
PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 13 21
Geometric Mean (Geometric Coefficient of Variation) [Micrograms per milliliter]
1.425
(35.6)
0.3544
(84.4)
1.082
(38.6)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: GSK3640254 200 mg Capsules, Part 1: GSK3640254 200 mg Tablets
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 4.101
Confidence Interval (2-Sided) 90%
3.2442 to 5.1830
Parameter Dispersion Type:
Value:
Estimation Comments Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: GSK3640254 200 mg Tablets, Part 2: GSK3640254 200 mg Tablet (High Fat)
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 3.080
Confidence Interval (2-Sided) 90%
2.4359 to 3.8935
Parameter Dispersion Type:
Value:
Estimation Comments Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)
8. Primary Outcome
Title Time of Maximum Observed Concentration for GSK3640254-Part 2
Description Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Time Frame pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Outcome Measure Data

Analysis Population Description
PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 13 21
Median (Full Range) [Hours]
5.000
4.000
5.000
9. Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1
Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is 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 or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Time Frame Up to Day 12

Outcome Measure Data

Analysis Population Description
Safety Population comprised of all participants who received at least 1 dose of study medication.
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
AEs
0
0%
1
11.1%
SAEs
0
0%
0
0%
10. Secondary Outcome
Title Number of Participants With AEs and SAEs-Part 2
Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is 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 or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Time Frame Up to Day 19

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
AEs
0
0%
0
0%
5
71.4%
SAEs
0
0%
0
0%
0
0%
11. Secondary Outcome
Title Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Description Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Basophils; Baseline; n=18, 18
0.032
(0.0134)
0.032
(0.0134)
Basophils; Day 2; n=18, 18
0.030
(0.0137)
0.030
(0.077)
Basophils; Day 5; n=9, 9
0.027
(0.0071)
0.030
(0.0166)
Eosinophils; Baseline; n=18, 18
0.100
(0.0832)
0.100
(0.0832)
Eosinophils; Day 2; n=18, 18
0.116
(0.0911)
0.122
(0.1101)
Eosinophils; Day 5; n=9, 9
0.133
(0.1227)
0.118
(0.0769)
Lymphocytes; Baseline; n=18, 18
1.617
(0.3975)
1.617
(0.3975)
Lymphocytes; Day 2; n=18, 18
1.726
(0.3852)
1.744
(0.4791)
Lymphocytes; Day 5; n=9, 9
1.639
(0.3536)
2.074
(0.6328)
Monocytes; Baseline; n=18, 18
0.403
(0.0859)
0.403
(0.0859)
Monocytes; Day 2; n=18, 18
0.409
(0.0955)
0.412
(0.1379)
Monocytes; Day 5; n=9, 9
0.386
(0.1100)
0.411
(0.1071)
Neutrophils; Baseline; n=18, 18
3.406
(1.0436)
3.406
(1.0436)
Neutrophils; Day 2; n=18, 18
2.925
(0.6617)
2.723
(0.9257)
Neutrophils; Day 5; n=9, 9
2.864
(0.7372)
3.108
(0.5724)
Platelets; Baseline; n=18, 18
232.5
(43.58)
232.5
(43.58)
Platelets; Day 2; n=18, 18
238.2
(49.37)
241.5
(48.56)
Platelets; Day 5; n=9, 9
267.1
(52.86)
231.4
(38.51)
12. Secondary Outcome
Title Absolute Values for Erythrocytes Count-Part 1
Description Blood samples were collected for the assessment of following hematology parameter: erythrocytes count.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Baseline; n=18, 18
4.801
(0.4605)
4.801
(0.4605)
Day 2; n=18, 18
4.937
(0.4896)
4.983
(0.5010)
Day 5; n=9, 9
5.009
(0.4786)
5.061
(0.3888)
13. Secondary Outcome
Title Absolute Values for Hemoglobin-Part 1
Description Blood samples were collected for the assessment of following hematology parameter: hemoglobin.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Baseline; n=18, 18
142.2
(13.46)
142.2
(13.46)
Day 2; n=18, 18
146.4
(13.74)
148.3
(14.29)
Day 5; n=9, 9
150.3
(15.74)
150.3
(13.13)
14. Secondary Outcome
Title Absolute Values for Hematocrit-Part 1
Description Blood samples were collected for the assessment of following hematology parameter: hematocrit.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Baseline; n=18, 18
0.4252
(0.03485)
0.4252
(0.03485)
Day 2; n=18, 18
0.4346
(0.03935)
0.4405
(0.03885)
Day 5; n=9, 9
0.4410
(0.04004)
0.4430
(0.03266)
15. Secondary Outcome
Title Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1
Description Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Baseline; n=18, 18
88.80
(4.887)
88.80
(4.887)
Day 2; n=18, 18
88.21
(4.480)
88.61
(4.363)
Day 5; n=9, 9
88.17
(4.532)
87.63
(4.971)
16. Secondary Outcome
Title Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1
Description Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Baseline; n=18, 18
29.68
(1.858)
29.68
(1.858)
Day 2; n=18, 18
29.69
(1.740)
29.83
(1.772)
Day 5; n=9, 9
30.08
(1.737)
29.74
(1.938)
17. Secondary Outcome
Title Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Description Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Basophils; Baseline; n=20, 19, 21
0.042
(0.0260)
0.042
(0.0260)
0.042
(0.0260)
Basophils; Day 2; n=20, 19, 21
0.041
(0.0276)
0.040
(0.0200)
0.043
(0.0215)
Basophils; Day 5; n=7, 5, 7
0.047
(0.0287)
0.036
(0.0167)
0.049
(0.0219)
Eosinophils; Baseline; n=20, 19, 21
0.141
(0.0879)
0.141
(0.0879)
0.141
(0.0879)
Eosinophils; Day 2; n=20, 19, 21
0.136
(0.0922)
0.135
(0.0837)
0.150
(0.1109)
Eosinophils; Day 5; n=7, 5, 7
0.146
(0.1050)
0.090
(0.0374)
0.151
(0.0915)
Lymphocytes; Baseline; n=20, 19, 21
1.650
(0.4926)
1.650
(0.4926)
1.650
(0.4926)
Lymphocytes; Day 2; n=20, 19, 21
1.576
(0.3410)
1.684
(0.4939)
1.583
(0.3748)
Lymphocytes; Day 5; n=7, 5, 7
1.806
(0.3577)
1.472
(0.2765)
1.923
(0.4442)
Monocytes; Baseline; n=20, 19, 21
0.469
(0.1445)
0.469
(0.1445)
0.469
(0.1445)
Monocytes; Day 2; n=20, 19, 21
0.446
(0.1589)
0.449
(0.1171)
0.446
(0.1553)
Monocytes; Day 5; n=7, 5, 7
0.530
(0.1788)
0.422
(0.0669)
0.504
(0.1130)
Neutrophils; Baseline; n=20, 19, 21
3.246
(1.0719)
3.246
(1.0719)
3.246
(1.0719)
Neutrophils; Day 2; n=20, 19, 21
2.908
(1.1660)
2.904
(0.8595)
2.947
(1.0824)
Neutrophils; Day 5; n=7, 5, 7
2.464
(0.9204)
3.472
(0.8987)
3.877
(1.4452)
Platelets; Baseline; n=20, 19, 21
259.9
(63.91)
259.9
(63.91)
259.9
(63.91)
Platelets; Day 2; n=20, 19, 21
284.2
(55.70)
270.6
(60.80)
281.3
(59.88)
Platelets; Day 5; n=7, 5, 7
255.9
(47.27)
272.4
(77.61)
291.3
(48.52)
18. Secondary Outcome
Title Absolute Values for Erythrocytes Count-Part 2
Description Blood samples were collected for the assessment of following hematology parameter: erythrocytes count.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Baseline; n=20, 19, 21
4.613
(0.5680)
4.613
(0.5680)
4.613
(0.5680)
Day 2; n=20, 19, 21
4.893
(0.5814)
4.899
(0.5878)
4.850
(0.5900)
Day 5; n=7, 5, 7
4.941
(0.6086)
4.424
(0.6683)
4.957
(0.6309)
19. Secondary Outcome
Title Absolute Values for Hemoglobin-Part 2
Description Blood samples were collected for the assessment of following hematology parameter: hemoglobin.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Baseline; n=20, 19, 21
134.0
(15.37)
134.0
(15.37)
134.0
(15.37)
Day 2; n=20, 19, 21
140.6
(15.83)
141.1
(16.19)
140.0
(15.37)
Day 5; n=7, 5, 7
146.9
(14.14)
124.2
(15.74)
142.7
(14.42)
20. Secondary Outcome
Title Absolute Values for Hematocrit-Part 2
Description Blood samples were collected for the assessment of following hematology parameter: hematocrit.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Baseline; n=20, 19, 21
0.4010
(0.03876)
0.4010
(0.03876)
0.4010
(0.03876)
Day 2; n=20, 19, 21
0.4207
(0.03989)
0.4219
(0.04146)
0.4176
(0.03777)
Day 5; n=7, 5, 7
0.4337
(0.03499)
0.3786
(0.04858)
0.4216
(0.03917)
21. Secondary Outcome
Title Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2
Description Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Baseline; n=20, 19, 21
86.98
(5.931)
86.98
(5.931)
86.98
(5.931)
Day 2; n=20, 19, 21
86.37
(5.934)
86.52
(6.038)
86.57
(5.867)
Day 5; n=7, 5, 7
88.47
(8.285)
85.86
(4.453)
85.41
(4.401)
22. Secondary Outcome
Title Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2
Description Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Baseline; n=20, 19, 21
29.05
(2.499)
29.05
(2.499)
29.05
(2.499)
Day 2; n=20, 19, 21
28.87
(2.415)
28.92
(2.449)
28.99
(2.411)
Day 5; n=7, 5, 7
29.96
(3.365)
28.14
(1.394)
28.93
(1.962)
23. Secondary Outcome
Title Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Description Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Basophils; Day 2; n=18, 18
-0.002
(0.0092)
-0.002
(0.0092)
Basophils; Day 5; n=9, 9
-0.002
(0.0083)
-0.004
(0.0073)
Eosinophils; Day 2; n=18, 18
0.016
(0.0322)
0.022
(0.0387)
Eosinophils; Day 5; n=9, 9
0.022
(0.0441)
0.029
(0.0462)
Lymphocytes; Day 2; n=18, 18
0.109
(0.2237)
0.127
(0.2350)
Lymphocytes; Day 5; n=9, 9
0.082
(0.2124)
0.398
(0.3721)
Monocytes; Day 2; n=18, 18
0.006
(0.0581)
0.008
(0.1164)
Monocytes; Day 5; n=9, 9
-0.009
(0.0821)
-0.001
(0.0637)
Neutrophils; Day 2; n=18, 18
-0.481
(0.7029)
-0.683
(0.8597)
Neutrophils; Day 5; n=9, 9
-0.291
(0.5628)
0.549
(0.7398)
Platelets; Day 2; n=18, 18
5.7
(21.18)
9.0
(18.89)
Platelets; Day 5; n=9, 9
20.8
(15.16)
12.8
(22.55)
24. Secondary Outcome
Title Change From Baseline in Erythrocytes Count-Part 1
Description Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Day 2; n=18, 18
0.136
(0.2431)
0.182
(0.2052)
Day 5; n=9, 9
0.253
(0.2320)
0.214
(0.1729)
25. Secondary Outcome
Title Change From Baseline in Hemoglobin-Part 1
Description Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Day 2; n=18, 18
4.2
(7.11)
6.1
(6.69)
Day 5; n=9, 9
8.7
(7.66)
7.6
(6.04)
26. Secondary Outcome
Title Change From Baseline in Hematocrit-Part 1
Description Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Day 2; n=18, 18
0.0094
(0.02265)
0.0153
(0.01912)
Day 5; n=9, 9
0.0189
(0.02196)
0.0147
(0.01362)
27. Secondary Outcome
Title Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 1
Description Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Day 2; n=18, 18
-0.59
(0.984)
-0.19
(1.050)
Day 5; n=9, 9
-0.84
(0.911)
-0.96
(0.592)
28. Secondary Outcome
Title Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 1
Description Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Day 2; n=18, 18
0.01
(0.344)
0.14
(0.365)
Day 5; n=9, 9
0.26
(0.343)
0.20
(0.439)
29. Secondary Outcome
Title Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Description Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Basophils; Day 2; n=20, 19, 21
-0.001
(0.0107)
-0.003
(0.0129)
0.001
(0.0128)
Basophils; Day 5; n=7, 5, 7
0.000
(0.0100)
0.006
(0.0114)
0.000
(0.0129)
Eosinophils; Day 2; n=20, 19, 21
0.001
(0.0424)
-0.006
(0.0519)
0.009
(0.0464)
Eosinophils; Day 5; n=7, 5, 7
0.007
(0.0423)
-0.030
(0.0738)
-0.009
(0.0402)
Lymphocytes; Day 2; n=20, 19, 21
-0.073
(0.2828)
0.006
(0.3097)
-0.068
(0.2313)
Lymphocytes; Day 5; n=7, 5, 7
0.257
(0.2146)
-0.010
(0.1454)
-0.024
(0.4172)
Monocytes; Day 2; n=20, 19, 21
-0.028
(0.1055)
-0.022
(0.0978)
-0.022
(0.1272)
Monocytes; Day 5; n=7, 5, 7
0.024
(0.1081)
0.000
(0.1058)
0.034
(0.1509)
Neutrophils; Day 2; n=20, 19, 21
-0.326
(0.7627)
-0.336
(0.7377)
-0.300
(0.7173)
Neutrophils; Day 5; n=7, 5, 7
-0.216
(0.6986)
0.154
(0.8131)
0.134
(1.1111)
Platelets; Day 2; n=20, 19, 21
21.6
(30.53)
9.4
(25.64)
21.4
(26.82)
Platelets; Day 5; n=7, 5, 7
38.0
(26.03)
-5.8
(28.08)
-1.1
(30.28)
30. Secondary Outcome
Title Change From Baseline in Erythrocytes Count-Part 2
Description Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Day 2; n=20, 19, 21
0.256
(0.1751)
0.247
(0.2564)
0.237
(0.1682)
Day 5; n=7, 5, 7
0.231
(0.1520)
0.172
(0.1678)
0.077
(0.2276)
31. Secondary Outcome
Title Change From Baseline in Hemoglobin-Part 2
Description Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Day 2; n=20, 19, 21
6.5
(4.96)
6.3
(7.39)
6.0
(4.21)
Day 5; n=7, 5, 7
7.0
(3.11)
4.2
(5.50)
2.4
(5.32)
32. Secondary Outcome
Title Change From Baseline in Hematocrit-Part 2
Description Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Day 2; n=20, 19, 21
0.0187
(0.01477)
0.0182
(0.02179)
0.0166
(0.01313)
Day 5; n=7, 5, 7
0.0179
(0.01378)
0.0106
(0.01731)
0.0046
(0.01855)
33. Secondary Outcome
Title Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2
Description Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Day 2; n=20, 19, 21
-0.35
(0.841)
-0.28
(0.897)
-0.41
(0.774)
Day 5; n=7, 5, 7
-0.06
(1.124)
-0.02
(1.103)
-0.33
(0.834)
34. Secondary Outcome
Title Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2
Description Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Day 2; n=20, 19, 21
-0.05
(0.330)
-0.05
(0.276)
-0.06
(0.356)
Day 5; n=7, 5, 7
0.10
(0.365)
0.18
(0.536)
0.13
(0.553)
35. Secondary Outcome
Title Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Description Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Creatinine; Baseline; n=18, 18
78.68
(15.983)
78.68
(15.983)
Creatinine; Day 2; n=18, 18
80.87
(15.104)
80.11
(14.243)
Creatinine; Day 5; n=9, 9
79.57
(17.196)
80.33
(11.925)
Total bilirubin; Baseline; n=18, 18
10.56
(3.578)
10.56
(3.578)
Total bilirubin; Day 2; n=18, 18
11.45
(4.334)
10.91
(2.952)
Total bilirubin; Day 5; n=9, 9
11.49
(1.590)
11.41
(3.867)
Direct bilirubin; Baseline; n=18, 18
1.96
(0.624)
1.96
(0.624)
Direct bilirubin; Day 2; n=18, 18
1.91
(0.643)
1.86
(0.631)
Direct bilirubin; Day 5; n=9, 9
1.86
(0.332)
1.90
(0.752)
Urate; Baseline; n=18, 18
306.7
(87.16)
306.7
(87.16)
Urate; Day 2; n=18, 18
283.2
(78.74)
282.5
(68.93)
Urate; Day 5; n=9, 9
281.4
(75.17)
282.9
(67.35)
36. Secondary Outcome
Title Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Description Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Calcium; Baseline; n=18, 18
2.327
(0.0451)
2.327
(0.0451)
Calcium; Day 2; n=18, 18
2.352
(0.0536)
2.378
(0.0830)
Calcium; Day 5; n=9, 9
2.343
(0.0705)
2.313
(0.0559)
Glucose; Baseline; n=18, 18
4.987
(0.3833)
4.987
(0.3833)
Glucose; Day 2; n=18, 18
4.842
(0.3451)
4.706
(0.2996)
Glucose; Day 5; n=9, 9
4.607
(0.2889)
4.600
(0.2182)
Potassium; Baseline; n=18, 18
4.00
(0.230)
4.00
(0.230)
Potassium; Day 2; n=18, 18
4.27
(0.256)
4.33
(0.379)
Potassium; Day 5; n=9, 9
4.18
(0.228)
4.13
(0.320)
Sodium; Baseline; n=18, 18
136.9
(2.19)
136.9
(2.19)
Sodium; Day 2; n=18, 18
138.5
(1.54)
138.9
(1.75)
Sodium; Day 5; n=9, 9
138.2
(1.48)
138.8
(1.48)
Chloride; Baseline; n=18, 18
102.3
(1.64)
102.3
(1.64)
Chloride; Day 2; n=18, 18
102.5
(1.69)
102.9
(1.66)
Chloride; Day 5; n=9, 9
101.9
(1.76)
101.8
(1.56)
Phosphate; Baseline; n=18, 18
1.121
(0.1289)
1.121
(0.1289)
Phosphate; Day 2; n=18, 18
1.197
(0.1058)
1.197
(0.1365)
Phosphate; Day 5; n=9, 9
1.173
(0.1413)
1.234
(0.0963)
BUN; Baseline; n=18, 18
3.728
(1.0672)
3.728
(1.0672)
BUN; Day 2; n=18, 18
4.747
(0.8949)
4.654
(0.8997)
BUN; Day 5; n=9, 9
5.053
(0.9143)
4.729
(0.7928)
Triglycerides; Baseline; n=18, 18
1.026
(0.6064)
1.026
(0.6064)
Triglycerides; Day 2; n=18, 18
1.127
(0.3973)
1.036
(0.3982)
Triglycerides; Day 5; n=9, 9
1.029
(0.3389)
0.904
(0.2605)
Cholesterol; Baseline; n=18, 18
4.549
(0.9656)
4.549
(0.9656)
Cholesterol; Day 2; n=18, 18
4.544
(0.8853)
4.632
(0.9164)
Cholesterol; Day 5; n=9, 9
4.519
(0.6212)
4.330
(1.1611)
Anion gap; Baseline; n=18, 18
9.5
(1.76)
9.5
(1.76)
Anion gap; Day 2; n=18, 18
10.1
(1.28)
10.0
(1.08)
Anion gap; Day 5; n=9, 9
10.7
(0.87)
10.1
(0.93)
Carbon dioxide; Baseline; n=18, 18
29.1
(2.00)
29.1
(2.00)
Carbon dioxide; Day 2; n=18, 18
30.1
(1.86)
30.2
(1.58)
Carbon dioxide; Day 5; n=9, 9
29.9
(1.36)
31.0
(1.87)
37. Secondary Outcome
Title Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
Description Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
ALT; Baseline; n=18, 18
22.1
(12.44)
22.1
(12.44)
ALT; Day 2; n=18, 18
21.8
(13.38)
18.4
(9.28)
ALT; Day 5; n=9, 9
20.6
(14.51)
19.6
(7.07)
ALP; Baseline; n=18, 18
54.6
(11.32)
54.6
(11.32)
ALP; Day 2; n=18, 18
52.1
(11.59)
52.1
(10.96)
ALP; Day 5; n=9, 9
55.2
(12.34)
50.3
(5.87)
AST; Baseline; n=18, 18
21.7
(8.39)
21.7
(8.39)
AST; Day 2; n=18, 18
19.1
(6.65)
17.6
(4.94)
AST; Day 5; n=9, 9
19.0
(4.30)
17.0
(3.71)
GGT; Baseline; n=18, 18
19.3
(11.26)
19.3
(11.26)
GGT; Day 2; n=18, 18
18.1
(11.18)
18.9
(11.60)
GGT; Day 5; n=9, 9
19.2
(13.07)
15.8
(6.85)
CK; Baseline; n=18, 18
126.9
(62.61)
126.9
(62.61)
CK; Day 2; n=18, 18
87.4
(40.30)
92.2
(44.64)
CK; Day 5; n=9, 9
86.0
(35.27)
98.3
(50.21)
LDH; Baseline; n=18, 18
136.4
(20.82)
136.4
(20.82)
LDH; Day 2; n=18, 18
117.7
(21.06)
120.4
(21.17)
LDH; Day 5; n=9, 9
122.0
(20.91)
123.6
(18.53)
38. Secondary Outcome
Title Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Description Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Albumin; Baseline; n=18, 18
43.7
(2.52)
43.7
(2.52)
Albumin; Day 2; n=18, 18
43.8
(2.53)
44.4
(2.96)
Albumin; Day 5; n=9, 9
45.1
(2.85)
44.2
(2.82)
Globulin; Baseline; n=18, 18
27.5
(3.84)
27.5
(3.84)
Globulin; Day 2; n=18, 18
26.9
(4.58)
27.8
(4.35)
Globulin; Day 5; n=9, 9
26.2
(4.58)
28.0
(4.97)
Protein; Baseline; n=18, 18
71.2
(3.19)
71.2
(3.19)
Protein; Day 2; n=18, 18
70.7
(5.07)
72.2
(5.43)
Protein; Day 5; n=9, 9
71.3
(6.42)
72.2
(4.74)
39. Secondary Outcome
Title Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1
Description Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Amylase; Baseline; n=18, 18
43.3
(14.96)
43.3
(14.96)
Amylase; Day 2; n=18, 18
46.7
(18.11)
47.7
(21.31)
Amylase; Day 5; n=9, 9
44.3
(15.86)
47.6
(22.94)
Lipase; Baseline; n=18, 18
24.0
(11.24)
24.0
(11.24)
Lipase; Day 2; n=18, 18
26.7
(14.32)
26.2
(14.26)
Lipase; Day 5; n=9, 9
28.9
(14.98)
24.7
(12.66)
40. Secondary Outcome
Title Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Description Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Creatinine; Baseline; n=20, 19, 21
74.00
(13.855)
74.00
(13.855)
74.00
(13.855)
Creatinine; Day 2; n=20, 19, 21
81.95
(14.968)
83.34
(11.078)
80.18
(13.533)
Creatinine; Day 5; n=7, 5, 7
91.69
(7.992)
76.04
(14.435)
83.71
(15.520)
Total bilirubin; Baseline; n=20, 19, 21
9.05
(3.070)
9.05
(3.070)
9.05
(3.070)
Total bilirubin; Day 2; n=20, 19, 21
11.49
(4.185)
11.88
(4.544)
11.11
(3.517)
Total bilirubin; Day 5; n=7, 5, 7
13.34
(4.999)
14.30
(7.174)
10.46
(1.397)
Direct bilirubin; Baseline; n=20, 19, 21
1.89
(0.660)
1.89
(0.660)
1.89
(0.660)
Direct bilirubin; Day 2; n=20, 19, 21
2.12
(0.747)
2.17
(0.732)
2.07
(0.656)
Direct bilirubin; Day 5; n=7, 5, 7
2.29
(0.760)
2.38
(0.996)
1.87
(0.431)
Urate; Baseline; n=20, 19, 21
289.2
(73.13)
289.2
(73.13)
289.2
(73.13)
Urate; Day 2; n=20, 19, 21
277.7
(72.39)
299.4
(68.62)
275.4
(77.75)
Urate; Day 5; n=7, 5, 7
286.3
(48.83)
291.2
(96.66)
313.6
(79.74)
41. Secondary Outcome
Title Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Description Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Calcium; Baseline; n=20, 19, 21
2.312
(0.0973)
2.312
(0.0973)
2.312
(0.0973)
Calcium; Day 2; n=20, 19, 21
2.408
(0.0670)
2.369
(0.0671)
2.390
(0.0695)
Calcium; Day 5; n=7, 5, 7
2.446
(0.0500)
2.324
(0.0439)
2.367
(0.0640)
Glucose; Baseline; n=20, 19, 21
4.745
(0.3160)
4.745
(0.3160)
4.745
(0.3160)
Glucose; Day 2; n=20, 19, 21
4.716
(0.2093)
4.861
(0.2250)
4.775
(0.2039)
Glucose; Day 5; n=7, 5, 7
4.574
(0.3675)
4.608
(0.3518)
4.926
(0.2224)
Potassium; Baseline; n=20, 19, 21
4.16
(0.225)
4.16
(0.225)
4.16
(0.225)
Potassium; Day 2; n=20, 19, 21
4.26
(0.244)
4.17
(0.281)
4.14
(0.240)
Potassium; Day 5; n=7, 5, 7
3.84
(0.251)
3.94
(0.230)
4.17
(0.236)
Sodium; Baseline; n=20, 19, 21
138.4
(1.56)
138.4
(1.56)
138.4
(1.56)
Sodium; Day 2; n=20, 19, 21
137.9
(2.00)
137.9
(2.58)
137.4
(1.24)
Sodium; Day 5; n=7, 5, 7
137.3
(1.11)
136.2
(2.59)
136.3
(1.89)
Chloride; Baseline; n=20, 19, 21
102.4
(1.72)
102.4
(1.72)
102.4
(1.72)
Chloride; Day 2; n=20, 19, 21
102.0
(1.81)
102.2
(2.06)
102.0
(2.09)
Chloride; Day 5; n=7, 5, 7
100.3
(1.38)
101.8
(2.28)
100.4
(2.37)
Phosphate; Baseline; n=20, 19, 21
1.100
(0.1813)
1.100
(0.1813)
1.100
(0.1813)
Phosphate; Day 2; n=20, 19, 21
1.191
(0.1827)
1.177
(0.1535)
1.176
(0.1730)
Phosphate; Day 5; n=7, 5, 7
1.297
(0.1577)
1.158
(0.2958)
1.117
(0.1612)
BUN; Baseline; n=20, 19, 21
4.190
(0.9187)
4.190
(0.9187)
4.190
(0.9187)
BUN; Day 2; n=20, 19, 21
4.526
(0.7144)
4.531
(0.8261)
4.403
(0.8736)
BUN; Day 5; n=7, 5, 7
4.921
(0.9744)
4.768
(0.4098)
5.050
(1.2701)
Triglycerides; Baseline; n=20, 19, 21
0.828
(0.3752)
0.828
(0.3752)
0.828
(0.3752)
Triglycerides; Day 2; n=20, 19, 21
0.957
(0.3872)
0.994
(0.3875)
0.890
(0.4024)
Triglycerides; Day 5; n=7, 5, 7
0.894
(0.3072)
0.774
(0.2790)
1.363
(0.6417)
Cholesterol; Baseline; n=20, 19, 21
4.533
(0.8776)
4.533
(0.8776)
4.533
(0.8776)
Cholesterol; Day 2; n=20, 19, 21
4.652
(0.7742)
4.639
(0.9975)
4.610
(0.8031)
Cholesterol; Day 5; n=7, 5, 7
4.520
(0.5269)
3.962
(0.8236)
4.454
(0.8948)
Anion gap; Baseline; n=20, 19, 21
11.3
(1.53)
11.3
(1.53)
11.3
(1.53)
Anion gap; Day 2; n=20, 19, 21
10.6
(1.15)
10.4
(1.17)
10.8
(1.54)
Anion gap; Day 5; n=7, 5, 7
11.7
(2.43)
10.8
(0.84)
11.9
(1.68)
Carbon dioxide; Baseline; n=20, 19, 21
28.7
(2.00)
28.7
(2.00)
28.7
(2.00)
Carbon dioxide; Day 2; n=20, 19, 21
29.6
(1.67)
29.5
(1.78)
28.6
(2.20)
Carbon dioxide; Day 5; n=7, 5, 7
29.3
(1.50)
27.6
(2.19)
28.1
(1.57)
42. Secondary Outcome
Title Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
Description Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
ALT; Baseline; n=20, 19, 21
19.0
(11.01)
19.0
(11.01)
19.0
(11.01)
ALT; Day 2; n=20, 19, 21
14.4
(6.06)
17.3
(9.49)
16.8
(9.20)
ALT; Day 5; n=7, 5, 7
16.7
(8.04)
11.0
(2.74)
22.7
(14.36)
ALP; Baseline; n=20, 19, 21
50.4
(16.47)
50.4
(16.47)
50.4
(16.47)
ALP; Day 2; n=20, 19, 21
56.5
(17.52)
57.4
(17.03)
56.7
(18.33)
ALP; Day 5; n=7, 5, 7
49.6
(22.40)
56.4
(9.58)
55.0
(13.69)
AST; Baseline; n=20, 19, 21
18.0
(6.01)
18.0
(6.01)
18.0
(6.01)
AST; Day 2; n=20, 19, 21
14.9
(3.01)
15.8
(4.29)
16.0
(4.11)
AST; Day 5; n=7, 5, 7
16.7
(4.42)
14.0
(2.12)
16.6
(3.78)
GGT; Baseline; n=20, 19, 21
17.1
(5.80)
17.1
(5.80)
17.1
(5.80)
GGT; Day 2; n=20, 19, 21
16.5
(5.56)
17.4
(6.15)
17.3
(7.67)
GGT; Day 5; n=7, 5, 7
14.9
(3.72)
14.8
(0.45)
21.6
(13.31)
CK; Baseline; n=20, 19, 21
118.8
(79.80)
118.8
(79.80)
118.8
(79.80)
CK; Day 2; n=20, 19, 21
106.2
(80.82)
114.9
(101.61)
106.2
(81.94)
CK; Day 5; n=7, 5, 7
135.7
(108.77)
136.4
(109.71)
145.4
(170.90)
LDH; Baseline; n=20, 19, 21
133.6
(19.21)
133.6
(19.21)
133.6
(19.21)
LDH; Day 2; n=20, 19, 21
121.1
(17.48)
121.5
(21.60)
122.1
(18.56)
LDH; Day 5; n=7, 5, 7
118.4
(16.63)
110.0
(12.29)
126.0
(22.84)
43. Secondary Outcome
Title Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Description Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Albumin; Baseline; n=20, 19, 21
43.8
(2.90)
43.8
(2.90)
43.8
(2.90)
Albumin; Day 2; n=20, 19, 21
45.6
(2.68)
45.4
(2.27)
45.7
(2.99)
Albumin; Day 5; n=7, 5, 7
48.0
(2.58)
43.4
(2.07)
45.1
(2.97)
Globulin; Baseline; n=20, 19, 21
26.5
(3.19)
26.5
(3.19)
26.5
(3.19)
Globulin; Day 2; n=20, 19, 21
26.6
(3.33)
26.0
(3.43)
26.4
(3.43)
Globulin; Day 5; n=7, 5, 7
23.6
(1.51)
28.2
(2.49)
26.7
(1.25)
Protein; Baseline; n=20, 19, 21
70.3
(4.23)
70.3
(4.23)
70.3
(4.23)
Protein; Day 2; n=20, 19, 21
72.2
(3.56)
71.4
(3.20)
72.1
(4.31)
Protein; Day 5; n=7, 5, 7
71.6
(3.15)
71.6
(2.07)
71.9
(2.85)
44. Secondary Outcome
Title Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2
Description Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Amylase; Baseline; n=20, 19, 21
49.3
(16.33)
49.3
(16.33)
49.3
(16.33)
Amylase; Day 2; n=20, 19, 21
48.3
(15.91)
49.4
(18.86)
50.1
(18.22)
Amylase; Day 5; n=7, 5, 7
49.6
(22.33)
48.8
(8.53)
43.6
(14.89)
Lipase; Baseline; n=20, 19, 21
23.8
(17.88)
23.8
(17.88)
23.8
(17.88)
Lipase; Day 2; n=20, 19, 21
20.4
(10.04)
22.2
(12.81)
24.1
(11.45)
Lipase; Day 5; n=7, 5, 7
21.9
(9.39)
17.6
(8.23)
24.1
(13.26)
45. Secondary Outcome
Title Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Description Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Creatinine; Day 2; n=18, 18
2.19
(4.721)
1.43
(6.188)
Creatinine; Day 5; n=9, 9
3.64
(3.780)
-1.10
(5.169)
Total bilirubin; Day 2; n=18, 18
0.89
(2.659)
0.36
(2.632)
Total bilirubin; Day 5; n=9, 9
0.59
(3.297)
1.20
(2.513)
Direct bilirubin; Day 2; n=18, 18
-0.05
(0.399)
-0.10
(0.387)
Direct bilirubin; Day 5; n=9, 9
-0.12
(0.526)
-0.04
(0.361)
Urate; Day 2; n=18, 18
-23.5
(46.62)
-24.2
(43.16)
Urate; Day 5; n=9, 9
-29.8
(46.45)
-19.3
(36.96)
46. Secondary Outcome
Title Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Description Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Calcium; Day 2; n=18, 18
0.025
(0.0534)
0.051
(0.0828)
Calcium; Day 5; n=9, 9
0.019
(0.0762)
-0.016
(0.0548)
Glucose; Day 2; n=18, 18
-0.145
(0.3134)
-0.281
(0.4796)
Glucose; Day 5; n=9, 9
-0.252
(0.4474)
-0.514
(0.3475)
Potassium; Day 2; n=18, 18
0.27
(0.278)
0.33
(0.331)
Potassium; Day 5; n=9, 9
0.30
(0.296)
0.01
(0.247)
Sodium; Day 2; n=18, 18
1.6
(2.30)
2.0
(2.28)
Sodium; Day 5; n=9, 9
1.8
(2.77)
1.4
(1.33)
Chloride; Day 2; n=18, 18
0.2
(2.05)
0.7
(2.22)
Chloride; Day 5; n=9, 9
-0.2
(2.33)
-0.7
(1.73)
Phosphate; Day 2; n=18, 18
0.077
(0.1177)
0.077
(0.1223)
Phosphate; Day 5; n=9, 9
0.077
(0.1331)
0.090
(0.1282)
BUN; Day 2; n=18, 18
1.019
(0.9553)
0.926
(1.0408)
BUN; Day 5; n=9, 9
1.178
(1.0554)
1.148
(0.6297)
Triglycerides; Day 2; n=18, 18
0.101
(0.4182)
0.010
(0.4769)
Triglycerides; Day 5; n=9, 9
0.102
(0.2870)
-0.221
(0.5382)
Cholesterol; Day 2; n=18, 18
-0.005
(0.3983)
0.082
(0.4981)
Cholesterol; Day 5; n=9, 9
-0.148
(0.4463)
-0.102
(0.6612)
Anion gap; Day 2; n=18, 18
0.6
(2.03)
0.5
(1.95)
Anion gap; Day 5; n=9, 9
0.8
(2.64)
1.0
(1.22)
Carbon dioxide; Day 2; n=18, 18
0.9
(2.60)
1.1
(2.10)
Carbon dioxide; Day 5; n=9, 9
1.4
(2.60)
1.2
(1.56)
47. Secondary Outcome
Title Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
Description Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
ALT; Day 2; n=18, 18
-0.2
(5.34)
-3.6
(8.39)
ALT; Day 5; n=9, 9
1.3
(7.87)
-5.3
(12.32)
ALP; Day 2; n=18, 18
-2.4
(5.25)
-2.5
(4.74)
ALP; Day 5; n=9, 9
-1.7
(7.40)
-1.9
(3.37)
AST; Day 2; n=18, 18
-2.6
(4.68)
-4.2
(6.57)
AST; Day 5; n=9, 9
-1.4
(3.84)
-6.0
(8.70)
GGT; Day 2; n=18, 18
-1.2
(1.93)
-0.4
(2.94)
GGT; Day 5; n=9, 9
-2.1
(2.47)
-1.6
(3.88)
CK; Day 2; n=18, 18
-39.6
(39.29)
-34.8
(53.99)
CK; Day 5; n=9, 9
-23.3
(28.33)
-46.2
(76.08)
LDH; Day 2; n=18, 18
-18.7
(11.00)
-16.0
(11.86)
LDH; Day 5; n=9, 9
-13.9
(16.12)
-13.4
(16.13)
48. Secondary Outcome
Title Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Description Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Albumin; Day 2; n=18, 18
0.1
(2.80)
0.7
(3.04)
Albumin; Day 5; n=9, 9
0.9
(3.37)
1.0
(3.00)
Globulin; Day 2; n=18, 18
-0.6
(2.50)
0.3
(2.37)
Globulin; Day 5; n=9, 9
-0.7
(2.78)
-0.1
(1.76)
Protein; Day 2; n=18, 18
-0.5
(4.82)
1.0
(4.79)
Protein; Day 5; n=9, 9
0.2
(5.93)
0.9
(4.54)
49. Secondary Outcome
Title Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1
Description Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Amylase; Day 2; n=18, 18
3.3
(5.66)
4.3
(8.75)
Amylase; Day 5; n=9, 9
1.0
(6.52)
4.2
(6.22)
Lipase; Day 2; n=18, 18
2.7
(8.27)
2.2
(5.15)
Lipase; Day 5; n=9, 9
4.0
(6.56)
1.6
(3.28)
50. Secondary Outcome
Title Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Description Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Creatinine; Day 2; n=20, 19, 21
7.25
(5.306)
7.41
(4.836)
6.18
(4.833)
Creatinine; Day 5; n=7, 5, 7
10.10
(5.536)
8.86
(4.565)
7.19
(5.827)
Total bilirubin; Day 2; n=20, 19, 21
2.29
(2.650)
2.47
(3.448)
2.06
(2.729)
Total bilirubin; Day 5; n=7, 5, 7
3.89
(3.133)
4.04
(4.689)
1.69
(1.791)
Direct bilirubin; Day 2; n=20, 19, 21
0.21
(0.524)
0.22
(0.550)
0.18
(0.494)
Direct bilirubin; Day 5; n=7, 5, 7
0.31
(0.495)
0.16
(0.611)
0.11
(0.389)
Urate; Day 2; n=20, 19, 21
-16.5
(31.57)
-0.5
(29.49)
-13.8
(32.92)
Urate; Day 5; n=7, 5, 7
-6.7
(29.86)
-4.0
(34.62)
3.3
(27.67)
51. Secondary Outcome
Title Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Description Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Calcium; Day 2; n=20, 19, 21
0.098
(0.0777)
0.063
(0.0930)
0.078
(0.0590)
Calcium; Day 5; n=7, 5, 7
0.097
(0.0663)
0.068
(0.0867)
0.067
(0.0702)
Glucose; Day 2; n=20, 19, 21
-0.036
(0.2823)
0.087
(0.2938)
0.030
(0.2588)
Glucose; Day 5; n=7, 5, 7
-0.207
(0.3073)
-0.100
(0.2547)
0.113
(0.3935)
Potassium; Day 2; n=20, 19, 21
0.08
(0.249)
-0.01
(0.273)
-0.02
(0.270)
Potassium; Day 5; n=7, 5, 7
-0.26
(0.270)
-0.32
(0.377)
-0.04
(0.282)
Sodium; Day 2; n=20, 19, 21
-0.5
(2.06)
-0.5
(2.59)
-1.0
(2.00)
Sodium; Day 5; n=7, 5, 7
-1.9
(0.69)
-2.0
(1.41)
-1.4
(3.10)
Chloride; Day 2; n=20, 19, 21
-0.5
(1.67)
-0.2
(1.78)
-0.3
(2.29)
Chloride; Day 5; n=7, 5, 7
-1.9
(0.90)
-2.2
(1.10)
-1.0
(2.89)
Phosphate; Day 2; n=20, 19, 21
0.087
(0.0836)
0.065
(0.0973)
0.076
(0.0815)
Phosphate; Day 5; n=7, 5, 7
0.060
(0.0856)
0.124
(0.0953)
0.074
(0.0820)
BUN; Day 2; n=20, 19, 21
0.307
(0.8732)
0.257
(0.9884)
0.213
(0.9258)
BUN; Day 5; n=7, 5, 7
0.783
(1.1942)
0.684
(0.7695)
0.506
(0.9007)
Triglycerides; Day 2; n=20, 19, 21
0.115
(0.2130)
0.127
(0.2750)
0.062
(0.2884)
Triglycerides; Day 5; n=7, 5, 7
0.021
(0.2874)
0.226
(0.1254)
0.273
(0.5007)
Cholesterol; Day 2; n=20, 19, 21
0.103
(0.4625)
0.078
(0.5175)
0.077
(0.4478)
Cholesterol; Day 5; n=7, 5, 7
-0.033
(0.5333)
-0.286
(0.3791)
-0.339
(0.3855)
Anion gap; Day 2; n=20, 19, 21
-0.8
(1.41)
-0.9
(2.13)
-0.5
(1.66)
Anion gap; Day 5; n=7, 5, 7
1.0
(1.73)
0.4
(1.67)
-0.7
(1.98)
Carbon dioxide; Day 2; n=20, 19, 21
0.9
(1.59)
0.8
(1.18)
-0.1
(2.10)
Carbon dioxide; Day 5; n=7, 5, 7
-1.0
(2.00)
-0.4
(2.30)
0.4
(1.81)
52. Secondary Outcome
Title Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
Description Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
ALT; Day 2; n=20, 19, 21
-4.9
(8.61)
-2.5
(4.06)
-2.2
(8.48)
ALT; Day 5; n=7, 5, 7
-9.7
(13.03)
-3.4
(4.39)
5.7
(9.23)
ALP; Day 2; n=20, 19, 21
6.1
(5.61)
5.9
(5.91)
6.3
(6.21)
ALP; Day 5; n=7, 5, 7
3.9
(6.69)
2.2
(6.22)
-0.4
(6.50)
AST; Day 2; n=20, 19, 21
-3.3
(5.18)
-2.6
(4.40)
-2.0
(4.88)
AST; Day 5; n=7, 5, 7
-5.1
(6.26)
-2.8
(4.66)
0.6
(3.36)
GGT; Day 2; n=20, 19, 21
-1.1
(2.65)
-0.4
(1.80)
0.2
(3.09)
GGT; Day 5; n=7, 5, 7
-2.4
(3.31)
-1.4
(2.70)
2.1
(5.73)
CK; Day 2; n=20, 19, 21
-15.4
(27.15)
-10.7
(40.57)
-12.6
(31.50)
CK; Day 5; n=7, 5, 7
1.1
(78.79)
9.4
(92.62)
29.9
(152.85)
LDH; Day 2; n=20, 19, 21
-12.2
(10.28)
-12.4
(12.05)
-11.5
(11.97)
LDH; Day 5; n=7, 5, 7
-17.3
(14.95)
-17.8
(3.27)
-10.4
(15.05)
53. Secondary Outcome
Title Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Description Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Albumin; Day 2; n=20, 19, 21
2.0
(1.85)
1.8
(2.57)
1.9
(1.95)
Albumin; Day 5; n=7, 5, 7
3.4
(1.40)
1.8
(0.84)
1.1
(1.46)
Globulin; Day 2; n=20, 19, 21
0.2
(1.79)
-0.1
(2.26)
-0.1
(1.76)
Globulin; Day 5; n=7, 5, 7
0.1
(1.86)
0.1
(3.39)
-1.3
(1.80)
Protein; Day 2; n=20, 19, 21
2.1
(3.01)
1.7
(4.28)
1.8
(3.01)
Protein; Day 5; n=7, 5, 7
3.6
(2.23)
2.8
(4.09)
-0.1
(3.02)
54. Secondary Outcome
Title Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2
Description Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Amylase; Day 2; n=20, 19, 21
0.7
(5.68)
1.8
(8.70)
0.8
(8.27)
Amylase; Day 5; n=7, 5, 7
4.4
(4.86)
-1.8
(10.16)
-4.4
(8.26)
Lipase; Day 2; n=20, 19, 21
-2.6
(15.99)
-1.4
(13.01)
0.3
(17.39)
Lipase; Day 5; n=7, 5, 7
6.3
(7.54)
-3.0
(14.27)
-9.6
(24.84)
55. Secondary Outcome
Title Absolute Values for Urine Parameter: Specific Gravity-Part 1
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, indicated as ratio of urine density to water density.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Baseline; n=18, 18
1.0120
(0.00915)
1.0120
(0.00915)
Day 2; n=18, 18
1.0152
(0.00685)
1.0158
(0.00584)
Day 5; n=9, 9
1.0201
(0.00664)
1.0161
(0.00434)
56. Secondary Outcome
Title Absolute Values for Urine Parameter: Urobilinogen-Part 1
Description Urine samples were collected at indicated time points for the assessment of urine urobilinogen.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Baseline; n=18, 18
4.1384
(3.19235)
4.1384
(3.19235)
Day 2; n=18, 18
3.3860
(0.00000)
4.1384
(3.19235)
Day 5; n=9, 9
3.3860
(0.00000)
3.3860
(0.00000)
57. Secondary Outcome
Title Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1
Description Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0).
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Baseline; n=18, 18
6.03
(0.696)
6.03
(0.696)
Day 2; n=18, 18
6.14
(0.682)
6.25
(0.600)
Day 5; n=9, 9
5.72
(0.441)
5.89
(0.697)
58. Secondary Outcome
Title Absolute Values for Urine Parameter: Specific Gravity-Part 2
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, indicated as ratio of urine density to water density.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Baseline; n=20, 19, 21
1.0080
(0.00735)
1.0080
(0.00735)
1.0080
(0.00735)
Day 2; n=20, 19, 21
1.0166
(0.00675)
1.0151
(0.00552)
1.0163
(0.00419)
Day 5; n=7, 5, 7
1.0180
(0.00632)
1.0248
(0.00526)
1.0171
(0.00999)
59. Secondary Outcome
Title Absolute Values for Urine Parameter: Urobilinogen-Part 2
Description Urine samples were collected at indicated time points for the assessment of urine urobilinogen.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Baseline; n=20, 19, 21
4.6759
(4.03794)
4.6759
(4.03794)
4.6759
(4.03794)
Day 2; n=20, 19, 21
4.0632
(3.02853)
3.3860
(0.00000)
3.3860
(0.00000)
Day 5; n=7, 5, 7
3.3860
(0.00000)
6.0948
(6.05706)
5.3209
(5.11915)
60. Secondary Outcome
Title Absolute Values for Urine Parameter: pH-Part 2
Description Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0).
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Baseline; n=20, 19, 21
6.36
(0.727)
6.36
(0.727)
6.36
(0.727)
Day 2; n=20, 19, 21
6.15
(0.690)
6.08
(0.584)
6.10
(0.718)
Day 5; n=7, 5, 7
5.86
(0.627)
5.60
(0.418)
6.21
(0.393)
61. Secondary Outcome
Title Change From Baseline in Urine Parameter: Specific Gravity-Part 1
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, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Day 2; n=18, 18
0.0032
(0.01242)
0.0038
(0.01043)
Day 5; n=9, 9
0.0088
(0.01210)
0.0034
(0.01180)
62. Secondary Outcome
Title Change From Baseline in Urine Parameter: Urobilinogen-Part 1
Description Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Day 2; n=18, 18
-0.7524
(3.19235)
0.0000
(4.64555)
Day 5; n=9, 9
0.0000
(0.00000)
-1.5049
(4.51467)
63. Secondary Outcome
Title Change From Baseline in Urine Parameter: pH-Part 1
Description Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Day 2; n=18, 18
0.11
(1.008)
0.22
(0.974)
Day 5; n=9, 9
-0.17
(0.559)
-0.28
(1.121)
64. Secondary Outcome
Title Change From Baseline in Urine Parameter: Specific Gravity-Part 2
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, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Day 2; n=20, 19, 21
0.0084
(0.00942)
0.0066
(0.00718)
0.0083
(0.00728)
Day 5; n=7, 5, 7
0.0109
(0.00825)
0.0140
(0.01142)
0.0091
(0.00956)
65. Secondary Outcome
Title Change From Baseline in Urine Parameter: Urobilinogen-Part 2
Description Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Day 2; n=20, 19, 21
-0.6772
(5.33680)
-1.4275
(4.27045)
-1.2899
(4.07394)
Day 5; n=7, 5, 7
0.0000
(0.00000)
-2.7088
(6.05706)
1.9349
(5.11915)
66. Secondary Outcome
Title Change From Baseline in Urine Parameter: pH-Part 2
Description Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day -1), Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Day 2; n=20, 19, 21
-0.18
(0.799)
-0.18
(0.730)
-0.26
(0.664)
Day 5; n=7, 5, 7
-0.43
(0.787)
-0.80
(0.837)
0.07
(0.450)
67. Secondary Outcome
Title Number of Participants With Abnormal Urine Dipstick Results-Part 1
Description Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented.
Time Frame Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Leukocyte esterase, Day 2, Trace
0
0%
1
11.1%
Leukocyte esterase, Day 2, 1+
1
11.1%
0
0%
Leukocyte esterase, Day 5, Trace
0
0%
1
11.1%
Leukocyte esterase, Day 5, 1+
0
0%
1
11.1%
Occult blood, Day 2, Trace
1
11.1%
1
11.1%
Occult blood, Day 2, 1+
1
11.1%
0
0%
68. Secondary Outcome
Title Number of Participants With Abnormal Urine Dipstick Results-Part 2
Description Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented.
Time Frame Day 2 and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Ketones; Day 5; Trace
1
11.1%
0
0%
0
0%
Ketones; Day 5; 2+
0
0%
0
0%
1
14.3%
Leukocyte esterase; Day 2; 1+
0
0%
0
0%
1
14.3%
Occult blood; Day 2; Trace
0
0%
0
0%
1
14.3%
Occult blood; Day 2; 2+
1
11.1%
0
0%
0
0%
Occult blood; Day 2; 3+
0
0%
0
0%
2
28.6%
69. Secondary Outcome
Title Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
Description Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals.
Time Frame Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
PR interval, Baseline; n=18, 18
164.1
(22.81)
162.3
(20.76)
PR interval, Day 1 (2 hours); n=18, 18
166.3
(21.55)
158.7
(19.95)
PR interval, Day 1 (4 hours); n=18, 18
160.6
(20.94)
158.9
(19.19)
PR interval, Day 5; n=9, 9
161.8
(11.68)
169.3
(26.14)
QRS duration, Baseline; n=18, 18
93.4
(9.30)
92.5
(8.09)
QRS duration, Day 1 (2 hours); n=18, 18
91.9
(8.76)
92.6
(9.00)
QRS duration, Day 1 (4 hours); n=18, 18
94.1
(8.88)
93.8
(9.90)
QRS duration, Day 5; n=9, 9
94.3
(11.65)
92.4
(8.25)
QT interval, Baseline; n=18, 18
395.1
(14.22)
394.4
(24.04)
QT interval, Day 1 (2 hours); n=18, 18
383.3
(13.71)
383.6
(24.11)
QT interval, Day 1 (4 hours); n=18, 18
404.8
(16.36)
402.0
(27.67)
QT interval, Day 5; n=9, 9
393.4
(16.38)
402.7
(18.71)
QTcF interval, Baseline; n=18, 18
399.4
(9.76)
401.9
(15.01)
QTcF interval, Day 1 (2 hours); n=18, 18
389.5
(12.11)
392.8
(15.09)
QTcF interval, Day 1 (4 hours); n=18, 18
398.7
(11.13)
402.6
(19.46)
QTcF interval, Day 5; n=9, 9
400.8
(13.34)
399.4
(11.98)
70. Secondary Outcome
Title Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
Description Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals.
Time Frame Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
PR interval, Baseline; n=20, 19, 21
166.4
(16.48)
166.2
(15.40)
166.8
(17.01)
PR interval, Day 1 (2 hours); n=20, 19, 21
163.9
(18.45)
166.8
(15.23)
161.7
(16.82)
PR interval, Day 1 (4 hours); n=20, 19, 21
165.2
(17.74)
165.7
(15.29)
162.6
(13.99)
PR interval, Day 5; n=7, 5, 7
173.4
(19.16)
171.6
(14.57)
163.1
(12.36)
QRS duration, Baseline; n=20, 19, 21
92.1
(9.76)
91.7
(9.02)
90.1
(10.42)
QRS duration, Day 1 (2 hours); n=20, 19, 21
88.9
(9.68)
92.6
(9.82)
89.7
(9.86)
QRS duration, Day 1 (4 hours); n=20, 19, 21
91.1
(10.63)
93.2
(8.45)
90.3
(8.69)
QRS duration, Day 5; n=7, 5, 7
101.1
(7.10)
85.8
(8.07)
88.7
(5.28)
QT interval, Baseline; n=20, 19, 21
391.8
(28.22)
388.5
(24.78)
389.7
(26.09)
QT interval, Day 1 (2 hours); n=20, 19, 21
379.7
(25.70)
399.2
(22.43)
376.2
(22.54)
QT interval, Day 1 (4 hours); n=20, 19, 21
401.0
(25.84)
406.9
(22.25)
389.1
(25.95)
QT interval, Day 5; n=7, 5, 7
401.7
(33.29)
391.0
(10.27)
378.9
(25.15)
QTcF interval, Baseline; n=20, 19, 21
395.3
(21.06)
392.4
(19.45)
391.9
(21.63)
QTcF interval, Day 1 (2 hours); n=20, 19, 21
384.0
(19.91)
391.7
(21.77)
388.3
(18.91)
QTcF interval, Day 1 (4 hours); n=20, 19, 21
396.8
(21.90)
395.5
(20.75)
393.3
(20.78)
QTcF interval, Day 5; n=7, 5, 7
391.9
(30.45)
402.4
(7.70)
388.1
(22.81)
71. Secondary Outcome
Title Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
Description Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
PR interval, Day 1 (2 hours); n=18, 18
2.2
(8.35)
-3.6
(10.01)
PR interval, Day 1 (4 hours); n=18, 18
-3.6
(11.61)
-3.3
(10.85)
PR interval, Day 5; n=9, 9
-0.9
(13.72)
3.2
(8.35)
QRS duration, Day 1 (2 hours); n=18, 18
-1.5
(2.81)
0.1
(6.06)
QRS duration, Day 1 (4 hours); n=18, 18
0.7
(3.63)
1.3
(4.92)
QRS duration, Day 5; n=9, 9
-0.3
(3.74)
0.8
(3.46)
QT interval, Day 1 (2 hours); n=18, 18
-11.8
(10.70)
-10.8
(11.18)
QT interval, Day 1 (4 hours); n=18, 18
9.7
(13.99)
7.6
(16.85)
QT interval, Day 5; n=9, 9
-1.3
(10.00)
5.0
(26.51)
QTcF interval, Day 1 (2 hours); n=18, 18
-9.9
(6.49)
-9.1
(9.16)
QTcF interval, Day 1 (4 hours); n=18, 18
-0.7
(7.71)
0.7
(9.23)
QTcF interval, Day 5; n=9, 9
-0.7
(7.19)
3.9
(7.93)
72. Secondary Outcome
Title Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
Description Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
PR interval, Day 1 (2 hours); n=20, 19, 21
-2.5
(7.02)
0.7
(7.90)
-5.0
(8.29)
PR interval, Day 1 (4 hours); n=20, 19, 21
-1.2
(8.47)
-0.4
(11.52)
-4.2
(6.79)
PR interval, Day 5; n=7, 5, 7
2.0
(4.08)
1.6
(11.26)
-2.7
(16.42)
QRS duration, Day 1 (2 hours); n=20, 19, 21
-3.2
(3.44)
0.9
(3.90)
-0.5
(3.03)
QRS duration, Day 1 (4 hours); n=20, 19, 21
-1.0
(4.18)
1.5
(4.45)
0.2
(4.12)
QRS duration, Day 5; n=7, 5, 7
0.4
(3.21)
-0.4
(3.13)
0.4
(2.88)
QT interval, Day 1 (2 hours); n=20, 19, 21
-12.1
(18.05)
10.6
(12.36)
-13.4
(15.31)
QT interval, Day 1 (4 hours); n=20, 19, 21
9.2
(18.08)
18.4
(12.90)
-0.6
(14.14)
QT interval, Day 5; n=7, 5, 7
-2.1
(10.67)
-12.4
(13.28)
-2.9
(7.95)
QTcF interval, Day 1 (2 hours); n=20, 19, 21
-11.3
(7.04)
-0.6
(7.33)
-3.5
(8.70)
QTcF interval, Day 1 (4 hours); n=20, 19, 21
1.6
(7.50)
3.1
(7.75)
1.4
(7.64)
QTcF interval, Day 5; n=7, 5, 7
-0.4
(9.34)
-1.4
(3.91)
1.7
(8.30)
73. Secondary Outcome
Title Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1
Description Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
SBP; Baseline
118.3
(9.73)
117.4
(12.26)
SBP; Day 2
113.8
(10.32)
115.1
(11.94)
SBP; Day 3
113.6
(12.13)
113.3
(9.71)
SBP; Day 4
112.2
(11.11)
113.9
(10.57)
SBP; Day 5
112.2
(9.62)
113.8
(8.91)
DBP; Baseline
72.1
(8.35)
73.4
(8.51)
DBP; Day 2
70.1
(7.06)
71.3
(10.56)
DBP; Day 3
70.4
(7.72)
69.1
(8.46)
DBP; Day 4
70.2
(6.98)
68.7
(6.77)
DBP; Day 5
70.1
(7.68)
68.9
(5.76)
74. Secondary Outcome
Title Absolute Values for Vital Sign: Pulse Rate-Part 1
Description Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Baseline
65.7
(5.27)
66.2
(10.00)
Day 2
66.7
(7.02)
68.4
(8.71)
Day 3
67.4
(7.79)
68.6
(9.58)
Day 4
67.4
(7.89)
65.6
(9.37)
Day 5
64.4
(6.97)
66.9
(8.39)
75. Secondary Outcome
Title Absolute Values for Vital Sign: Respiratory Rate-Part 1
Description Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Baseline; n=18, 18
14.0
(2.66)
14.9
(1.71)
Day 2; n=17, 17
13.1
(2.56)
13.9
(2.69)
Day 3; n=17, 18
14.7
(2.11)
15.2
(2.49)
Day 4; n=18, 18
13.9
(2.87)
14.7
(3.07)
Day 5; n=18, 18
14.0
(2.47)
14.1
(1.75)
76. Secondary Outcome
Title Absolute Values for Vital Sign: Temperature-Part 1
Description Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Baseline
36.24
(0.393)
36.37
(0.361)
Day 2
36.22
(0.426)
36.39
(0.407)
Day 3
36.33
(0.420)
36.22
(0.383)
Day 4
36.38
(0.402)
36.35
(0.385)
Day 5
36.21
(0.555)
36.27
(0.324)
77. Secondary Outcome
Title Absolute Values for Vital Signs: DBP and SBP-Part 2
Description Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
SBP, Baseline
120.8
(17.53)
115.2
(11.46)
117.4
(13.01)
SBP, Day 2
117.4
(11.84)
116.6
(11.32)
115.7
(11.73)
SBP, Day 3
115.8
(10.63)
117.2
(11.47)
116.6
(12.36)
SBP, Day 4
119.0
(12.75)
115.4
(11.14)
118.0
(16.87)
SBP, Day 5
118.2
(12.92)
115.8
(12.76)
118.0
(13.18)
DBP, Baseline
74.8
(10.44)
71.4
(9.62)
71.8
(7.51)
DBP, Day 2
72.5
(9.26)
74.2
(9.83)
71.1
(7.48)
DBP, Day 3
72.9
(7.57)
72.9
(9.24)
72.4
(7.53)
DBP, Day 4
71.9
(6.94)
73.5
(8.32)
70.5
(9.26)
DBP, Day 5
72.0
(8.61)
72.3
(7.64)
68.7
(9.18)
78. Secondary Outcome
Title Absolute Values for Vital Sign: Pulse Rate-Part 2
Description Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Baseline
65.4
(12.47)
64.1
(7.70)
63.8
(7.85)
Day 2
66.9
(12.76)
64.0
(10.66)
64.1
(7.94)
Day 3
66.7
(11.28)
64.9
(14.16)
67.4
(11.04)
Day 4
70.8
(12.90)
68.2
(11.25)
72.6
(12.36)
Day 5
67.6
(11.19)
69.1
(9.11)
69.6
(13.99)
79. Secondary Outcome
Title Absolute Values for Vital Sign: Respiratory Rate-Part 2
Description Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Baseline
14.8
(1.20)
15.3
(2.02)
13.8
(2.27)
Day 2
14.3
(2.27)
15.4
(1.64)
14.2
(2.36)
Day 3
15.0
(2.00)
14.5
(1.98)
14.2
(2.18)
Day 4
14.9
(2.38)
14.0
(3.06)
14.3
(2.22)
Day 5
13.7
(1.63)
14.5
(1.61)
14.6
(1.80)
80. Secondary Outcome
Title Absolute Values for Vital Sign: Temperature-Part 2
Description Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
Baseline
36.24
(0.421)
36.50
(0.298)
36.37
(0.483)
Day 2
36.29
(0.476)
36.40
(0.406)
36.27
(0.508)
Day 3
36.33
(0.351)
36.37
(0.425)
36.29
(0.419)
Day 4
36.37
(0.404)
36.37
(0.378)
36.38
(0.495)
Day 5
36.34
(0.345)
36.49
(0.375)
36.51
(0.459)
81. Secondary Outcome
Title Change From Baseline in Vital Signs: SBP and DBP-Part 1
Description Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
SBP; Day 2
-4.5
(7.52)
-2.3
(7.22)
SBP; Day 3
-4.7
(9.63)
-4.1
(9.63)
SBP; Day 4
-6.1
(7.45)
-3.4
(10.18)
SBP; Day 5
-6.1
(7.49)
-3.6
(11.37)
DBP; Day 2
-2.0
(6.82)
-2.2
(5.78)
DBP; Day 3
-1.7
(7.46)
-4.3
(4.80)
DBP; Day 4
-1.9
(6.98)
-4.7
(6.99)
DBP; Day 5
-2.1
(7.46)
-4.6
(7.17)
82. Secondary Outcome
Title Change From Baseline in Vital Sign: Pulse Rate-Part 1
Description Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Time Frame Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Day 2
1.1
(5.76)
2.2
(7.50)
Day 3
1.8
(8.20)
2.4
(7.41)
Day 4
1.7
(6.93)
-0.6
(7.88)
Day 5
-1.3
(5.46)
0.8
(10.70)
83. Secondary Outcome
Title Change From Baseline in Vital Sign: Respiratory Rate-Part 1
Description Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Day 2; n=17, 17
-1.1
(3.47)
-0.8
(3.00)
Day 3; n=17, 18
0.6
(2.62)
0.3
(3.58)
Day 4; n=18, 18
-0.1
(2.78)
-0.2
(3.35)
Day 5; n=18, 18
0.0
(2.74)
-0.8
(2.76)
84. Secondary Outcome
Title Change From Baseline in Vital Sign: Temperature-Part 1
Description Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 1: GSK3640254 200 mg Capsules Part 1: GSK3640254 200 mg Tablets
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
Measure Participants 18 18
Day 2
-0.03
(0.329)
0.02
(0.472)
Day 3
0.09
(0.442)
-0.15
(0.444)
Day 4
0.13
(0.452)
-0.02
(0.458)
Day 5
-0.04
(0.501)
-0.11
(0.330)
85. Secondary Outcome
Title Change From Baseline in Vital Signs: SBP and DBP-Part 2
Description Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5

Outcome Measure Data

Analysis Population Description
Safety Population
Arm/Group Title Part 2: GSK3640254 200 mg Tablet (Moderate Fat) Part 2: GSK3640254 200 mg Tablet (Fasted) Part 2: GSK3640254 200 mg Tablet (High Fat)
Arm/Group Description Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3. Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
Measure Participants 20 19 21
SBP, Day 2
-3.5
(10.50)
1.5
(6.59)
-1.7
(7.65)
SBP, Day 3
-5.1
(12.99)
2.1
(7.74)
-0.9
(9.11)
SBP, Day 4
-1.9
(12.28)
0.3
(6.10)
0.6
(9.95)
SBP, Day 5
-2.6
(11.23)
0.7
(8.28)
0.6
(7.71)
DBP, Day 2
-2.4
(6.10)
2.8
(5.07)
-0.7
(4.90)
DBP, Day 3
-1.9
(6.40)
1.5
(7.83)