A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants

August 18, 2023 updated by: ViiV Healthcare

A Two-Part, Randomized, Open-Label, Single Dose, Crossover Clinical Study to Assess the Relative Bioavailability of Fixed-Dose Combinations of GSK3640254 and Dolutegravir and to Assess the Effect of Food on the Select Fixed Dose Combination of GSK3640254 and Dolutegravir in Healthy Participants

This is a two part study to compare the relative bioavailability (BA) of 2 fixed dose combinations (FDCs) of GSK3640254/DTG with GSK3640254 and DTG administered together as single agents (Part 1) and to assess the effect of food on the pharmacokinetic (PK) of the selected FDC of GSK3640254/DTG (Part 2).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78744
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
  • Participants capable of giving signed informed consent.

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 gastro intestinal anatomy or motility (for example [e.g.], gastroesophageal reflux disease, gastric ulcers, gastritis) or 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).
  • Clinically significant illness, including viral syndromes within 3 weeks of dosing.
  • Participant with known or suspected active Coronavirus disease (COVID)-19 infection or contact with an individual with known COVID-19, within 14 days of study enrollment.
  • Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention (including an investigational COVID vaccine) or any other type of medical research.
  • Prior exposure to GSK3640254 or prior intolerance to DTG in this or another clinical study.
  • 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, any degree of atrioventricular block, or conduction abnormality) which, in the opinion of the investigator or ViiV Healthcare (VH)/GlaxoSmithKline (GSK) medical monitor, will interfere with the safety for the individual participant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 : Treatment sequence ABC
Participants will receive a single oral dose of GSK3640254 25 milligrams (mg) (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A) in Period 1, followed by a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B) in Period 2. In Period 3, participants will receive a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C).
Drug: GSK3640254
GSK3640254 will be administered via oral route.
Drug: DTG
DTG will be administered via oral route.
Drug: GSK3640254/DTG
GSK3640254/DTG will be administered via oral route.
Experimental: Part 1 : Treatment sequence BCA
Participants will receive a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B) in Period 1, followed by a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C) in Period 2. In Period 3 participants will receive a single oral dose of GSK3640254 25 mg (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A).
Drug: GSK3640254
GSK3640254 will be administered via oral route.
Drug: DTG
DTG will be administered via oral route.
Drug: GSK3640254/DTG
GSK3640254/DTG will be administered via oral route.
Experimental: Part 1 : Treatment sequence CAB
Participants will receive a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C) in period 1, followed by a single oral dose of GSK3640254 25 mg (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A) in Period 2. In Period 3 participants will receive a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B).
Drug: GSK3640254
GSK3640254 will be administered via oral route.
Drug: DTG
DTG will be administered via oral route.
Drug: GSK3640254/DTG
GSK3640254/DTG will be administered via oral route.
Experimental: Part 2 : Treatment sequence DE
Participants will receive a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions (Treatment D) in Period 1 followed by a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions (Treatment E) in Period 2.
Drug: GSK3640254/DTG
GSK3640254/DTG will be administered via oral route.
Experimental: Part 2 : Treatment sequence ED
Participants will receive a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions (Treatment E) in Period 1 followed by a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions (Treatment D) in Period 2.
Drug: GSK3640254/DTG
GSK3640254/DTG will be administered via oral route.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK3640254
Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254.
Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Time t (AUC[0-t]) of GSK3640254
Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Part 1: Maximum Observed Concentration (Cmax) of GSK3640254
Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Part 1: AUC(0-inf) of DTG
Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of DTG.
Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Part 1: AUC(0-t) of DTG
Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of DTG.
Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Part 1: Cmax of DTG
Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of DTG.
Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Part 2: AUC(0-inf) of GSK3640254
Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Part 2: AUC(0-t) of GSK3640254
Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period.
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period.
Part 2: Cmax of GSK3640254
Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Part 2: AUC(0-inf) of DTG
Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of DTG.
Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Part 2: AUC(0-t) of DTG
Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of DTG.
Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Part 2: Cmax of DTG
Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of DTG.
Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 17 days
An adverse event (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. A SAE is defined as any serious adverse event 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 other situations as per medical or scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.
Up to 17 days
Part 2: Number of Participants With Non-SAEs and SAEs
Time Frame: Up to 9 days
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. A SAE is defined as any serious adverse event 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 other situations as per medical or scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.
Up to 9 days
Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Absolute Values for Hematology Parameter: Hemoglobin
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 2: Absolute Values for Hematology Parameter: Hemoglobin
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Absolute Values for Hematology Parameter: Erythrocytes
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 2: Absolute Values for Hematology Parameter: Erythrocytes
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Absolute Values for Hematology Parameters: Hematocrit
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 2: Absolute Values for Hematology Parameters: Hematocrit
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: hemotocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameters: hemotocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5, and 7
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)
Time Frame: Baseline (Day -1), and Days 2, 5, and 7
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1), and Days 2, 5, and 7
Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Time Frame: Baseline (Day -1), and Days 2, 5, and 7
Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1), and Days 2, 5, and 7
Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Time Frame: Baseline (Day -1), and Days 2, 5, and 7
Blood samples were collected to analyze the chemistry parameters: serum lipase and serum amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1), and Days 2, 5, and 7
Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the chemistry parameters: serum lipase, serum amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Time Frame: Baseline (Day -1), and Days 2, 5, and 7
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1), and Days 2, 5, and 7
Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Time Frame: Baseline (Day -1), and Days 2, 5, and 7
Blood samples were collected to analyze the chemistry parameters: creatinine, direct bilirubin, bilirubin, urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1), and Days 2, 5, and 7
Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the chemistry parameters: creatinine, direct bilirubin, bilirubin, and urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5, and 7
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, LDH, CK. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5, and 7
Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the chemistry parameters: calcium, CO2, chloride, glucose, potassium, sodium, urea nitrogen, phosphorus, triglycerides, cholesterol, and anion gap. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Blood samples were collected to analyze the chemistry parameters: lipase and amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5, and 7
Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the chemistry parameters: lipase and amylase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Time Frame: Baseline (Day -1) and Days 2, 5, 7
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5, 7
Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Blood samples were collected to analyze the chemistry parameters: creatinine, direct bilirubin, bilirubin, and urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5, and 7
Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Blood samples were collected to analyze the chemistry parameters: Creatinine, direct bilirubin, bilirubin, and urate. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5, and 7
Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH)
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5, and 7
Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Urine samples were collected at indicated time points to analyze parameters including glucose by dipstick. Urinalysis included dipstick urine test which was used to screen for glucose. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5, and 7
Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Urine samples were collected at indicated time points to analyze parameters including glucose by dipstick. Urinalysis included dipstick urine test which was used to screen for glucose. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Number of Participants With Urinalysis Dipstick Results: Protein
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Urine samples were collected at indicated time points to analyze parameters including protein by dipstick. Urinalysis included dipstick urine test which was used to screen for protein. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine protein can be read as negative, and trace in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5, and 7
Part 2: Number of Participants With Urinalysis Dipstick Results: Protein
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Urine samples were collected at indicated time points to analyze parameters including protein by dipstick. Urinalysis included dipstick urine test which was used to screen for protein. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine protein can be read as negative, and trace in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Urine samples were collected at indicated time points to analyze parameters including occult blood by dipstick. Urinalysis included dipstick urine test which was used to screen for occult blood. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine occult blood can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5, and 7
Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Urine samples were collected at indicated time points to analyze parameters including occult blood by dipstick. Urinalysis included dipstick urine test which was used to screen for occult blood. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine occult blood can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Urine samples were collected at indicated time points to analyze parameters including ketones by dipstick. Urinalysis included dipstick urine test which was used to screen for ketones. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine ketones can be read as negative, trace, 2+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5, and 7
Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Urine samples were collected at indicated time points to analyze parameters including ketones by dipstick. Urinalysis included dipstick urine test which was used to screen for ketones. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine ketones can be read as negative, trace, 1+, 2+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Urine samples were collected at indicated time points to analyze parameters including bilirubin and nitrite by dipstick. Urinalysis included dipstick urine test which was used to screen for bilirubin and nitrite. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine bilirubin and nitrite can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5, and 7
Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Urine samples were collected at indicated time points to analyze parameters including bilirubin and nitrite by dipstick. Urinalysis included dipstick urine test which was used to screen for bilirubin and nitrite. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine bilirubin and nitrite can be read as negative in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Urine samples were collected at indicated time points to analyze parameters including leukocyte esterase by dipstick. Urinalysis included dipstick urine test which was used to screen for leukocyte esterase. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine leukocyte esterase can be read as negative, trace, 1+ indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5, and 7
Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Urine samples were collected at indicated time points to analyze parameters including leukocyte esterase by dipstick. Urinalysis included dipstick urine test which was used to screen for leukocyte esterase. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine leukocyte esterase can be read as negative, trace indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5, and 7
Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen
Time Frame: Baseline (Day -1) and Days 2, 5, and 7
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visit, prior to the first study drug administration in each treatment period. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day -1) and Days 2, 5, and 7
Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen
Time Frame: Baseline (Day -1) and Days 2, 5 and 7
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. 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.
Baseline (Day -1) and Days 2, 5 and 7
Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Time Frame: Up to Day 17
Urine samples were collected to analyze the urine parameter: glucose. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Up to Day 17
Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Time Frame: Up to Day 9
Urine samples were collected to analyze the urine parameter: glucose. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Up to Day 9
Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Time Frame: Up to Day 17
Urine samples were collected to analyze the urine parameter: protein. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Up to Day 17
Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Time Frame: Up to Day 9
Urine samples were collected to analyze the urine parameter: protein. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Up to Day 9
Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Time Frame: Up to Day 17
Urine samples were collected to analyze the urine parameter: erythrocytes. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Up to Day 17
Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Time Frame: Up to Day 9
Urine samples were collected to analyze the urine parameter: erythrocytes. Urinalysis parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) grading for severity of laboratory toxicities and clinical adverse events, version 2.1. The grades were grade 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening). Baseline was defined as the last assessment before the first dose of the study treatment. Only those urine parameters with maximum post-Baseline grade increase (Grade 1 to Grade 4) have been presented.
Up to Day 9
Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Day 5
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, and QTcF interval . 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 average of the triplicate pre-dose assessments within each treatment
Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Day 5
Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Days 5, 7
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, and QTcF interval. 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 average of the triplicate pre-dose assessments within each treatment.
Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Days 5, 7
Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
Time Frame: Baseline (Day 1, Pre-dose), and Day 1: 2, 4, 6 hours, and Day 5
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval. 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 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.
Baseline (Day 1, Pre-dose), and Day 1: 2, 4, 6 hours, and Day 5
Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, Days 5 and 7
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcF interval. 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 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.
Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, Days 5 and 7
Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7
SBP and DBP were measured in the semi-supine position with a completely automated device after 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.
Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7
Part 2: Absolute Values of Vital Signs: DBP and SBP
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5 and 7
SBP and DBP were measured in the semi-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 average of the triplicate predose assessments within each treatment.
Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5 and 7
Part 1: Absolute Values of Vital Signs: Pulse Rate
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7
Pulse rate was measured in the semi-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 average of the triplicate predose assessments within each treatment.
Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7
Part 2: Absolute Values of Vital Signs: Pulse Rate
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7
Pulse rate was measured in the semi-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 average of the triplicate predose assessments within each treatment.
Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7
Part 1: Absolute Values of Vital Signs: Oral Temperature
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7
Oral temperature were measured in the semi-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 average of the triplicate predose assessments within each treatment.
Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7
Part 2: Absolute Values of Vital Signs: Oral Temperature
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7
Oral temperature were measured in the semi-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 average of the triplicate predose assessments within each treatment.
Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7
Part 1: Absolute Values of Vital Signs: Respiratory Rate
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7
Respiratory rate was measured in the semi-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 average of the triplicate predose assessments within each treatment.
Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7
Part 2: Absolute Values of Vital Signs: Respiratory Rate
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
Respiratory rate was measured in the semi-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 average of the triplicate predose assessments within each treatment.
Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
Part 1: Change From Baseline in Vital Signs: DBP and SBP
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7
SBP and DBP were measured in the semi-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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7
Part 2: Change From Baseline in Vital Signs: DBP and SBP
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
SBP and DBP were measured in the semi-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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
Part 1: Change From Baseline in Vital Signs: Pulse Rate
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7
Pulse rate was measured in the semi-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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7
Part 2: Change From Baseline in Vital Signs: Pulse Rate
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
Pulse rate was measured in the semi-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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
Part 1: Change From Baseline in Vital Signs: Oral Temperature
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7
Oral temperature was measured in the semi-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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7
Part 2: Change From Baseline in Vital Signs: Oral Temperature
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, 6 and 7
Oral temperature was measured in the semi-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. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, 6 and 7
Part 1: Change From Baseline in Vital Signs: Respiratory Rate
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
Respiratory rate was measured in the semi-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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
Part 2: Change From Baseline in Vital Signs: Respiratory Rate
Time Frame: Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7
Respiratory rate was measured in the semi-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 average of the triplicate predose assessments within each treatment. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ViiV Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, ViiV Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 213055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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