Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction Compared to Placebo and a Single Oral Dose of Moxifloxacin
- Conditions
- HIV Infections
- Interventions
- Registration Number
- NCT04563845
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
This study will aim to evaluate the effect of therapeutic and supratherapeutic oral doses of GSK3640254 on cardiac conduction compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. The study has 2 parts: Part 1 will determine the supratherapeutic dose for Part 2, which will be the main corrected QT interval (QTc) study. Part 1 will evaluate once daily (QD) dosing of GSK3640254 or placebo and Part 2 will investigate the safety, tolerability and Pharmacokinetics (PK) of GSK3640254 doses on cardiac conduction as compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. Moxifloxacin will be included as a positive control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Participants receiving placebo GSK3640254 Participants will receive a single dose of placebo once daily for 7 days following ingestion of a moderate fat meal. Part 1: Participants receiving placebo Placebo Participants will receive a single dose of placebo once daily for 7 days following ingestion of a moderate fat meal. Part 1: Participants receiving GSK3640254 500 milligrams (mg) GSK3640254 Participants will receive a single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal. Part 2: Main QTc Study GSK3640254 Participants will be randomized to 1:1:1:1 ratio to receive Treatment T- Therapeutic dose of GSK3640254 (100 mg QD) on Days 1 through 7 or Treatment ST- Supratherapeutic dose of GSK3640254 (to be determined from Part 1) on Days 1 through 7 or Treatment P- Placebo for GSK3640254 on Days 1 through 7 or Treatment M- Moxifloxacin (GSK3640254 placebo Days 1 through 6 and a single dose of Moxifloxacin \[400 mg\] on Day 7 in 4 treatment periods. There will be at least 7 days wash out period between each period. Part 2: Main QTc Study Placebo Participants will be randomized to 1:1:1:1 ratio to receive Treatment T- Therapeutic dose of GSK3640254 (100 mg QD) on Days 1 through 7 or Treatment ST- Supratherapeutic dose of GSK3640254 (to be determined from Part 1) on Days 1 through 7 or Treatment P- Placebo for GSK3640254 on Days 1 through 7 or Treatment M- Moxifloxacin (GSK3640254 placebo Days 1 through 6 and a single dose of Moxifloxacin \[400 mg\] on Day 7 in 4 treatment periods. There will be at least 7 days wash out period between each period. Part 2: Main QTc Study Moxifloxacin Participants will be randomized to 1:1:1:1 ratio to receive Treatment T- Therapeutic dose of GSK3640254 (100 mg QD) on Days 1 through 7 or Treatment ST- Supratherapeutic dose of GSK3640254 (to be determined from Part 1) on Days 1 through 7 or Treatment P- Placebo for GSK3640254 on Days 1 through 7 or Treatment M- Moxifloxacin (GSK3640254 placebo Days 1 through 6 and a single dose of Moxifloxacin \[400 mg\] on Day 7 in 4 treatment periods. There will be at least 7 days wash out period between each period.
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs Up to Day 9 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 defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.
Part 1: Absolute Values for Hematology Parameter: Hemoglobin Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at idicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze the hematology parameter: Erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, 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.
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) of GSK3640254 Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 Blood samples were collected at indicated time points. Pharmacokinetic (PK) analysis was conducted using standard non-compartmental methods.
Part 1: AUC From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254 Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Part 1: Maximum Observed Concentration (Cmax) of GSK3640254 Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Part 1: Time of Maximum Observed Concentration (Tmax) of GSK3640254 Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Part 1: Plasma Concentration of GSK3640254 Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 Blood samples were collected at indicated time points to analyze the plasma concentration of GSK3640254.
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. .
Part 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254 Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 1: Plasma Concentration of Major Metabolites of GSK3640254 Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7 Blood samples were to be collected at indicated time points to analyze the plasma concentration of major metabolites of GSK3640254.
Part 1: Absolute Values for Hematology Parameter: Hematocrit Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 1: Change From Baseline in Hematology Parameter: Hematocrit Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated timepoints to analyze hemotocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin Baseline (Day -2), Day 3, Day 7, Day 9 Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein Baseline (Day -2), Day 3, Day 7, Day 9 Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, 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. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value
Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase Baseline (Day -2), Day 3, Day 7, and Day 9 Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity Baseline (Day -2), Day 3, Day 7, and Day 9 Urine samples were collected at indicated time points to analyze the urine 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.
Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH) Baseline (Day -2), Day 3, Day 7, and Day 9 Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. 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.
Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity Baseline (Day -2), Day 3, Day 7, and Day 9 Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 1: Change From Baseline in Urinalysis Parameter: pH Baseline (Day -2), Day 3, Day 7, and Day 9 Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings Baseline(Day-2), Day1: 2 Hours, 4 Hours, 6 Hours; Day 4: 2 Hours, 4 Hours, 6 Hours, Day 7: 2 Hours, 4 Hours, 6 Hours and Day 9 A 12-lead ECG was recorded with the participant in a supine position. 12-lead ECGs were obtained by using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal 12-Lead ECG findings has reported
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9 SBP and DBP were measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 1: Absolute Values for Vital Parameter: Pulse Rate Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9 Pulse rate was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 1: Absolute Values for Vital Parameter: Temperature Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9 Temperature was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions.Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg Using Concentration-QTc (C-QTc) Analysis Baseline (Pre-dose, Day 1) and up to Day 7 Twelve-lead ECGs were recorded in participant using automated ECG machine \& performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline was calculated by subtracting Baseline value from post dose value. Placebo-corrected change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated as difference in model-predicted mean change from Baseline in QTcF between treatment groups using C-QTc analysis. A linear mixed-effects model with change from Baseline in QTcF as the dependent variable, time-matched GSK3640254 plasma concentration as a fixed effect, centered Baseline as additional covariate,treatment \&time as categorical factors, \& a random intercept \& slope per participant. In all calculations, concentrations in participants who received placebo were set to 0.
Part 2: Plasma Concentration of GSK3640254 Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period Blood samples were collected at indicated time points to analyze the plasma concentration of GSK3640254.
Part 2: Plasma Concentration of Major Metabolites of GSK3640254 Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period Blood samples were to be collected at indicated time points to analyze the plasma concentration of major metabolites of GSK3640254.
- Secondary Outcome Measures
Name Time Method Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose Twelve-lead ECGs were recorded in participant using automated ECG machine \& performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated by subtracting Baseline value from post dose value.
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose Twelve-lead ECGs were recorded in participant using automated ECG machine \& performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline was calculated by subtracting Baseline value from post dose value. Placebo-corrected change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated as model-predicted mean change from Baseline in QTcF in GSK3640254 group minus model-predicted mean change from Baseline in QTcF in the placebo group (by-time point analysis). Time point analysis was performed based on a linear mixed-effects model: Change from Baseline in QTcF = Time + Treatment + Time\*Treatment +Baseline QTcF + Period + Sequence. An unstructured covariance structure was used to specify the repeated measures (time within participant and period). A random intercept per participant was also included.
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in HR was calculated as model-predicted mean change from Baseline in HR in GSK3640254 group minus model-predicted mean change from Baseline in HR in the placebo group.
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in PR was calculated as model-predicted mean change from Baseline in PR interval in GSK3640254 group minus model-predicted mean change from Baseline in PR interval in the placebo group.
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Baseline (Day -2), Day 8, Day 9, Day 14 Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in QRS was calculated as model-predicted mean change from Baseline in QRS interval in GSK3640254 group minus model-predicted mean change from Baseline in QRS interval in the placebo group.
Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg Up to Day 51 Twelve-lead ECGs were recorded using an automated ECG machine with participant in a supine position after a rest of at least 10 minutes. Number of participants with outlier results for HR, QTcF, ΔQTcF, PR interval and QRS interval were summarized.Categorical outlier criteria was as follows:change from Baseline in QTcF (ΔQTcF) \>60 ms: Increase of QTc from Baseline \> 60 ms, QTcF \> 500 ms:Treatment-emergent value of \> 500 ms when not present at Baseline (new onset), HR \< 50 bpm with a decrease in change from Baseline in heart rate (ΔHR) \> 25%:Decrease of HR from Baseline \>25% resulting in HR \< 50 bpm, HR \> 100 bpm with an increase in ΔHR \> 25% :Increase of HR from Baseline \>25% resulting in HR \> 100 bpm, PR \> 200 ms with an increase in change from Baseline in PR interval (ΔPR) \> 25%:Increase of PR from Baseline \> 25% resulting in PR \> 200 ms, QRS \> 120 ms with an increase in change from Baseline in QRS interval (ΔQRS) \> 25%:Increase of QRS from Baseline \> 25% resulting in QRS \> 120 ms.
Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg Up to Day 51 Twelve-lead ECGs were recorded using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Flat T-wave=T-amplitude \< 1 mm (either positive \[+\] or negative \[-\]), including flat isoelectric line, Notched T-wave (+)=Presence of notch(es) of at least 0.05 millivolt (mV) amplitude on ascending or descending arm of the positive T-wave, Biphasic= T-wave that contains a second component with an opposite phase that is at least 0.1 mV deep (both positive/negative and negative/positive and polyphasic T-waves included), Normal T-wave (-)=T-amplitude that is negative, without biphasic T-wave or notches, Notched T-wave (-): Presence of notch(es) of at least 0.05 mV amplitude on descending or ascending arm of the negative T-wave, U-waves= Presence of abnormal U-waves. Data has been reported for Flat T-wave, Notched T-wave (Positive), Biphasic, Normal T-wave (Negative), Notched T-wave (Negative) and T-U wave Fusion.
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in QTcF was calculated as model-predicted mean change from Baseline in QTcF in moxifloxacin group minus model-predicted mean change from Baseline in QTcF in the placebo group.
Part 2: AUC(0-t) of GSK3640254 100 mg and GSK3640254 500 mg Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods .
Part 2: AUC(0-tau) of GSK3640254 100 mg and GSK3640254 500 mg Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Part 2: Cmax of GSK3640254 100 mg and GSK3640254 500 mg Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Part 2: Ctau of GSK3640254 100 mg and GSK3640254 500 mg Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Part 2: Tmax of GSK3640254 100 mg and GSK3640254 500 mg Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Part 2: Cmax of Moxifloxacin 400 mg Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods
Part 2: Tmax of Moxifloxacin 400 mg Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Part 2: Number of Participants With Non-SAEs and SAEs Up to Day 51 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 defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.
Part 2: Absolute Values for Hematology Parameter: Hemoglobin Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Part 2: Absolute Values for Hematology Parameter: Hematocrit Baseline (Day -2), Day 8, Day 9, Day 14 Blood samples were collected at indicated time points to analyze hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume Baseline (Day -2), Day 8, Day 9, Day 14 Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Baseline (Day -2), Day 8, Day 9, Day 14 Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Part 2: Change From Baseline in Hematology Parameter: Hematocrit Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated time points to analyze hematocrit . Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, 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 for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated time points to analyze Erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, 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 for each period, including those from unscheduled visit.
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated time points to analyze erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity Baseline (Day -2), Day 8, Day 9, and Day 14 Urine samples were collected at indicated time points to analyze the urine 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 for each period, including those from unscheduled visit.
Part 2: Absolute Values for Urinalysis Parameter: pH Baseline (Day -2), Day 8, Day 9, and Day 14 Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. 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 for each period, including those from unscheduled visit.
Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity Baseline (Day -2), Day 8, Day 9, and Day 14 Urine samples were collected at indicated time points to analyze the urine 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 for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Change From Baseline in Urinalysis Parameter: pH Baseline (Day -2), Day 8, Day 9, and Day 14 Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. 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 for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings Baseline(Day-2), Day1: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours; Day 2: 24 Hours, Day 4: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, Day 5: 24 Hours; Day 7: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours; Day 8: 24 Hours; Day 9 and Day 14 A 12-lead ECG was recorded with the participant in a supine position. 12-lead ECGs were obtained by using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal 12-Lead ECG findings has reported.
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase Baseline (Day -2), Day 8, Day 9, and Day 14 Blood samples were collected at indicated timepoints to analyze amylase, lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part 2: Absolute Values for Vital Parameters: SBP and DBP Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, and Day 14 SBP and DBP were measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Part 2: Absolute Values for Vital Parameter: Pulse Rate Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, and Day 14 Pulse rate was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Part 2: Absolute Values for Vital Parameter: Temperature Baseline (Pre-dose, Day 1), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, and Day 14 Temperature was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Austin, Texas, United States