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

Phase 1

Terminated

• Conditions: HIV Infections
• Interventions: Drug: GSK3640254 Tablet; Drug: GSK3640254 Capsule

• Registration Number: NCT04128293
• Lead Sponsor: ViiV Healthcare

Brief Summary

This is an open-label, single-dose, four-period, four sequential, and crossover study conducted to assess the relative bioavailability of GSK3640254 mesylate tablets and GSK3640254 mesylate capsules (in the presence of a moderate fat meal). This study will also evaluate the effect of food (fasted, moderate fat meal, and high fat meal) on the pharmacokinetics of GSK3640254 mesylate tablet formulation. 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 16 participants will be enrolled and the duration of the study will be approximately 54 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-01
• Study Start: 2019-10-08
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-15
• Status Verified: 2020-07
• Results First Submitted: 2020-08-07
• Results First Submitted QC: 2020-08-07
• Last Update Submitted: 2020-08-07
• Results First Posted: 2020-08-25
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1 - Treatment ABCD	GSK3640254 Tablet	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; followed by GSK3640254 200 mg (Treatment C- Reference), tablets, orally under fasted conditions on Day 1 in third intervention period; further followed by GSK3640254 200 mg (Treatment D- Test), tablets, orally under high fat conditions on Day 1 in fourth intervention period. There will be at least 7 days wash out period between each dose of study intervention.
Sequence 3 - Treatment CDAB	GSK3640254 Tablet	Participants will receive a single dose of GSK3640254 200 mg (Treatment C- Reference), tablets, orally under fasted conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment D- Test), tablets, orally under high fat conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment A- Reference), capsules, orally under moderate fat conditions on Day 1 in third intervention period; further followed by GSK3640254 200 mg (Treatment B- Test), tablets, orally under moderate fat conditions on Day 1 in first intervention period. There will be at least 7 days wash out period between each dose of study intervention.
Sequence 1 - Treatment ABCD	GSK3640254 Capsule	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; followed by GSK3640254 200 mg (Treatment C- Reference), tablets, orally under fasted conditions on Day 1 in third intervention period; further followed by GSK3640254 200 mg (Treatment D- Test), tablets, orally under high fat conditions on Day 1 in fourth intervention period. There will be at least 7 days wash out period between each dose of study intervention.
Sequence 3 - Treatment CDAB	GSK3640254 Capsule	Participants will receive a single dose of GSK3640254 200 mg (Treatment C- Reference), tablets, orally under fasted conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment D- Test), tablets, orally under high fat conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment A- Reference), capsules, orally under moderate fat conditions on Day 1 in third intervention period; further followed by GSK3640254 200 mg (Treatment B- Test), tablets, orally under moderate fat conditions on Day 1 in first intervention period. There will be at least 7 days wash out period between each dose of study intervention.
Sequence 4 - Treatment DCBA	GSK3640254 Tablet	Participants will receive a single dose of GSK3640254 200 mg (Treatment D- Test), tablets, orally under high fat conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment C- Reference), tablets, orally under fasted conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment B- Test), tablets, orally under moderate fat conditions on Day 1 in third intervention period; further followed by GSK3640254 200 mg (Treatment A- Reference), capsules, orally under moderate fat conditions on Day 1 in first intervention period. There will be at least 7 days wash out period between each dose of study intervention.
Sequence 2 - Treatment BADC	GSK3640254 Tablet	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; followed by GSK3640254 200 mg (Treatment D- Test), tablets, orally under high fat conditions on Day 1 in third intervention period; further followed by GSK3640254 200 mg (Treatment C- Reference), tablets, orally under fasted conditions on Day 1 in fourth intervention period. There will be at least 7 days wash out period between each dose of study intervention.
Sequence 2 - Treatment BADC	GSK3640254 Capsule	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; followed by GSK3640254 200 mg (Treatment D- Test), tablets, orally under high fat conditions on Day 1 in third intervention period; further followed by GSK3640254 200 mg (Treatment C- Reference), tablets, orally under fasted conditions on Day 1 in fourth intervention period. There will be at least 7 days wash out period between each dose of study intervention.
Sequence 4 - Treatment DCBA	GSK3640254 Capsule	Participants will receive a single dose of GSK3640254 200 mg (Treatment D- Test), tablets, orally under high fat conditions on Day 1 in first intervention period; followed by GSK3640254 200 mg (Treatment C- Reference), tablets, orally under fasted conditions on Day 1 in second intervention period; followed by GSK3640254 200 mg (Treatment B- Test), tablets, orally under moderate fat conditions on Day 1 in third intervention period; further followed by GSK3640254 200 mg (Treatment A- Reference), capsules, orally under moderate fat conditions on Day 1 in first intervention period. There will be at least 7 days wash out period between each dose of study intervention.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B)	Pre-dose and at 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 analysis of GSK3640254. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.
AUC(0-infinity) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D)	Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Maximum Observed Concentration (Cmax) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B)	Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time of Cmax (Tmax) for GSK3640254 200 mg Tablets Under Fed, Fasted and High Fat Condition (Treatment B, C and D)	Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
AUC(0-t) for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D)	Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Time of Cmax (Tmax) for GSK3640254 200 mg Capsules Under Fed Condition (Treatment A)	Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for GSK3640254 200 mg Capsules and Tablets Under Fed Condition (Treatment A and B)	Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Cmax for GSK3640254 200 mg Tablets Under Fasted and High Fat Condition (Treatment C and D)	Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in SBP and DBP	Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5	SBP and DBP were measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Lag Time for Absorption (Tlag) for GSK3640254	Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Apparent Terminal Phase Half-life (t1/2) for GSK3640254	Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Apparent Oral Clearance (CL/F) for GSK3640254	Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Apparent Volume of Distribution (Vz/F) for GSK3640254	Pre-dose and at 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 analysis of GSK3640254. The PK parameters were calculated by standard non-compartmental analysis.
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to Day 14	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication.
Absolute Values for Hematology Parameter: Hematocrit	Day 2	Blood samples were collected to analyze the hematology parameter: hematocrit.
Absolute Values for Body Temperature	Days 2, 3, 4, and 5	Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin	Baseline (Day -1) and at Day 2	Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume	Day 2	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count	Day 2	Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count.
Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase	Day 2	Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.
Absolute Values for Hematology Parameter: Erythrocytes	Day 2	Blood samples were collected to analyze the hematology parameter: erythrocytes.
Absolute Values for Hematology Parameter: Hemoglobin	Day 2	Blood samples were collected to analyze the hematology parameter: hemoglobin.
Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen	Day 2	Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.
Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin	Day 2	Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.
Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein	Day 2	Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.
Absolute Values for Urine Parameter: Specific Gravity	Day 2	Urine samples were collected to analyze the urine parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine.
Absolute Values for Urine Parameter: Urobilinogen	Day 2	Urine samples were collected to analyze the urine parameter: urobilinogen.
Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF), Corrected QT Interval Using Bazett's Formula (QTcB)	Day 1: 2 hours and 4 hours	Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.
Change From Baseline in Hematology Parameter: Erythrocytes	Baseline (Day -1) and at Day 2	Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein	Baseline (Day -1) and at Day 2	Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB	Baseline (Day 1, Pre-dose), Day 1: 2 hours and 4 hours	Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in Pulse Rate	Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5	Pulse rate was measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline was defined as the average of the triplicate pre-dose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	Day 2	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
Absolute Values for Chemistry Parameters: Amylase, Lipase	Day 2	Blood samples were collected to analyze the chemistry parameters: amylase and lipase.
Absolute Values for Pulse Rate	Days 2, 3, 4, and 5	Pulse rate was measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions.
Change From Baseline in Hematology Parameter: Hemoglobin	Baseline (Day -1) and at Day 2	Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in Hematology Parameter: Hematocrit	Baseline (Day -1) and at Day 2	Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase	Baseline (Day -1) and at Day 2	Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in Respiratory Rate	Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5	Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Absolute Values for Urine Parameter: Potential of Hydrogen (pH)	Day 2	Urine samples were collected to analyze the urine parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0).
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Days 2, 3, 4, and 5	SBP and DBP were measured in the semi-recumbent position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without any distractions.
Absolute Values for Respiratory Rate	Days 2, 3, 4, and 5	Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count	Baseline (Day -1) and at Day 2	Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume	Baseline (Day -1) and at Day 2	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	Baseline (Day -1) and at Day 2	Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen	Baseline (Day -1) and at Day 2	Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in Chemistry Parameters: Amylase, Lipase	Baseline (Day -1) and at Day 2	Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in Urinalysis Parameter: Urobilinogen	Baseline (Day -1) and at Day 2	Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in Body Temperature	Baseline (Day 1, Pre-dose), Days 2, 3, 4, and 5	Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in Urinalysis Parameter: Specific Gravity	Baseline (Day -1) and at Day 2	Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Change From Baseline in Urinalysis Parameter: pH	Baseline (Day -1) and at Day 2	Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, prior to the first dose of study drug administration. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Plasma Pharmacokinetic Concentration of GSK3640254	Pre-dose and at 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 analysis of GSK3640254. The PK Concentration Population included all participants who underwent plasma PK sampling and had evaluable PK assay results.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Austin, Texas, United States