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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 : Treatment sequence ABC | Experimental | 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). |
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| Part 1 : Treatment sequence BCA | Experimental | 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). |
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| Part 1 : Treatment sequence CAB | Experimental | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3640254 | Drug | GSK3640254 will be administered via oral route. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK3640254 | 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 | 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 | 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 | 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 | 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 | Blood samples were collected at indicated time points for PK analysis of DTG. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Austin | Texas | 78744 | United States |
IPD for this study will be made available via the Clinical Study Data Request site.
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.
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.
A total of 41 participants (23 participants in Part 1 and 18 participants in Part 2) were enrolled in the study.
This was a randomized, open-label, single dose, crossover clinical study to assess relative bioavailability and food-effect of the fixed dose combination (FDC) of GSK3640254 and Dolutegravir (DTG) in healthy participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Cohort 1: Sequence ABC | Participants received Treatment A as a single oral dose of GSK3640254 25 milligrams (mg) (2 tablets), GSK3640254 100 mg (1 tablet)/dolutegravir (DTG) 50 mg (1 tablet) administered together under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 2, further followed by Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 3. There was washout period of 7 days between each treatment period. |
| FG001 | Part 1: Cohort 2: Sequence BCA | Participants received Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 2, further followed by Treatment A as a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) administered together under moderate fat and calorie conditions on Day 1 on treatment period 3. There was washout period of 7 days between each treatment period. |
| FG002 | Part 1: Cohort 3: Sequence CAB | Participants received Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment A as a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet) and DTG 50 mg (1 tablet) administered together under moderate fat and calorie conditions (reference) on Day 1 in treatment period 2, further followed by Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 3. There was washout period of 7 days between each treatment period. |
| FG003 | Part 2: Cohort 1: Sequence DE | Participants received Treatment D as a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions on Day 1 in treatment Period 1, followed by Treatment E as a single oral dose of selected FDC of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in treatment Period 2. There was washout period of 7 days between each treatment period. |
| FG004 | Part 2: Cohort 2: Sequence ED | Participants received Treatment E as a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in treatment Period 1, followed by Treatment D as a single oral dose of selected FDC of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions on Day 1 in treatment Period 2. There was washout period of 7 days between each treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Part 1: Period 1 (Day 1) |
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| Part 1: Washout Period 1 (Up to 7 Days) |
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| Part 1: Period 2 (Day 1) |
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| Part 1: Washout Period 2 (Up to 7 Days) |
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| Part 1: Period 3 (Day 1) |
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| Part 2: Period 1 (Day 1) |
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| Part 2: Washout Period 1 (Up to 7 Days) |
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| Part 2: Period 2 (Day 1) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Cohort 1: Sequence ABC | Participants received Treatment A as a single oral dose of GSK3640254 25 milligrams (mg) (2 tablets), GSK3640254 100 mg (1 tablet)/dolutegravir (DTG) 50 mg (1 tablet) administered together under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 2, further followed by Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 3. There was washout period of 7 days between each treatment period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK3640254 | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254. | PK Parameter Population consisted of all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | 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 |
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All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to Day 17 in Part 1 and up to Day 9 in Part 2
Safety Population consisted of all participants who received at least one dose of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg | Participants received a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) together under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | ViiV Healthcare | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2021 | Aug 26, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2021 | Aug 26, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C000723722 | GSK3640254 |
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This is a 2-part crossover study.
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This is an open-label study
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| Part 2 : Treatment sequence DE | Experimental | 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. |
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| Part 2 : Treatment sequence ED | Experimental | 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. |
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| DTG | Drug | DTG will be administered via oral route. |
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| GSK3640254/DTG | Drug | GSK3640254/DTG will be administered via oral route. |
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| 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Up to 17 days |
| Part 2: Number of Participants With Non-SAEs and SAEs | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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| BG001 | Part 1: Cohort 2: Sequence BCA | Participants received Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 2, further followed by Treatment A as a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet), and DTG 50 mg (1 tablet) administered together under moderate fat and calorie conditions on Day 1 on treatment period 3. There was washout period of 7 days between each treatment period. |
| BG002 | Part 1: Cohort 3: Sequence CAB | Participants received Treatment C as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 bilayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 1 followed by Treatment A as a single oral dose of GSK3640254 25 mg (2 tablets), GSK3640254 100 mg (1 tablet) and DTG 50 mg (1 tablet) administered together under moderate fat and calorie conditions (reference) on Day 1 in treatment period 2, further followed by Treatment B as a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 monolayer tablet) FDC administered under moderate fat and calorie conditions on Day 1 in treatment period 3. There was washout period of 7 days between each treatment period. |
| BG003 | Part 2: Cohort 1: Sequence DE | Participants received Treatment D as a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions on Day 1 in treatment Period 1, followed by Treatment E as a single oral dose of selected FDC of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in treatment Period 2. There was washout period of 7 days between each treatment period. |
| BG004 | Part 2: Cohort 2: Sequence ED | Participants received Treatment E as a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in treatment Period 1, followed by Treatment D as a single oral dose of selected FDC of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions on Day 1 in treatment Period 2. There was washout period of 7 days between each treatment period. |
| BG005 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3. |
| OG002 | Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3. |
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| Primary | Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Time t (AUC[0-t]) of GSK3640254 | Blood samples were collected at indicated time points for PK analysis of GSK3640254. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | 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 |
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| Primary | Part 1: Maximum Observed Concentration (Cmax) of GSK3640254 | Blood samples were collected at indicated time points for PK analysis of GSK3640254. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 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 |
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| Primary | Part 1: AUC(0-inf) of DTG | Blood samples were collected at indicated time points for PK analysis of DTG. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | 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 |
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| Primary | Part 1: AUC(0-t) of DTG | Blood samples were collected at indicated time points for PK analysis of DTG. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | 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 |
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| Primary | Part 1: Cmax of DTG | Blood samples were collected at indicated time points for PK analysis of DTG. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 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 |
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| Primary | Part 2: AUC(0-inf) of GSK3640254 | Blood samples were collected at indicated time points for PK analysis of GSK3640254. | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | 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 |
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| Primary | Part 2: AUC(0-t) of GSK3640254 | Blood samples were collected at indicated time points for PK analysis of GSK3640254. | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | 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. |
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| Primary | Part 2: Cmax of GSK3640254 | Blood samples were collected at indicated time points for PK analysis of GSK3640254. | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 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 |
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| Primary | Part 2: AUC(0-inf) of DTG | Blood samples were collected at indicated time points for PK analysis of DTG. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | 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 |
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| Primary | Part 2: AUC(0-t) of DTG | Blood samples were collected at indicated time points for PK analysis of DTG. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | 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 |
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| Primary | Part 2: Cmax of DTG | Blood samples were collected at indicated time points for PK analysis of DTG. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | 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 |
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| Secondary | Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | 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. | Safety Population consisted of all participants who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to 17 days |
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| Secondary | Part 2: Number of Participants With Non-SAEs and SAEs | 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. | Safety Population | Posted | Count of Participants | Participants | Up to 9 days |
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| Secondary | Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Absolute Values for Hematology Parameter: Hemoglobin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 2: Absolute Values for Hematology Parameter: Hemoglobin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Femtoliter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Femtoliter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Absolute Values for Hematology Parameter: Erythrocytes | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^12 cells per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 2: Absolute Values for Hematology Parameter: Erythrocytes | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^12 cells per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Absolute Values for Hematology Parameters: Hematocrit | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 2: Absolute Values for Hematology Parameters: Hematocrit | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Picograms | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Picograms | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Change From Baseline in Hematology Parameter: Hemoglobin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 2: Change From Baseline in Hematology Parameter: Hemoglobin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Femtoliter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Femtoliter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^12 cells per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^12 cells per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Change From Baseline in Hematology Parameter: Hematocrit | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 2: Change From Baseline in Hematology Parameter: Hematocrit | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Picograms | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Picograms | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | 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) | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | International units per Liter | Baseline (Day -1), and Days 2, 5, and 7 |
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| Secondary | Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | International units per Liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day -1), and Days 2, 5, and 7 |
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| Secondary | Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Units per Liter | Baseline (Day -1), and Days 2, 5, and 7 |
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| Secondary | Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Units per Liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1), and Days 2, 5, and 7 |
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| Secondary | Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1), and Days 2, 5, and 7 |
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| Secondary | Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | International units per Liter | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | International units per Liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Units per Liter | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Units per Liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1) and Days 2, 5, 7 |
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| Secondary | Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Ratio | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Ratio | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH) | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | pH | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | pH | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Number of Participants With Urinalysis Dipstick Results: Protein | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2: Number of Participants With Urinalysis Dipstick Results: Protein | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Ratio | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Ratio | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | pH | Baseline (Day -1) and Days 2, 5, and 7 |
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| Secondary | Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | pH | Baseline (Day -1) and Days 2, 5 and 7 |
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| Secondary | Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | 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. | Safety Population | Posted | Count of Participants | Participants | Up to Day 17 |
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| Secondary | Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to Day 9 |
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| Secondary | Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | 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. | Safety Population | Posted | Count of Participants | Participants | Up to Day 17 |
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| Secondary | Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline | 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. | Safety Population | Posted | Count of Participants | Participants | Up to Day 9 |
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| Secondary | Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to Day 17 |
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| Secondary | Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline | 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. | Safety Population | Posted | Count of Participants | Participants | Up to Day 9 |
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| Secondary | Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) | 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 | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Milliseconds | Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Day 5 |
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| Secondary | Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Milliseconds | Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Days 5, 7 |
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| Secondary | Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Milliseconds | Baseline (Day 1, Pre-dose), and Day 1: 2, 4, 6 hours, and Day 5 |
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| Secondary | Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Milliseconds | Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, Days 5 and 7 |
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| Secondary | Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7 |
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| Secondary | Part 2: Absolute Values of Vital Signs: DBP and SBP | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5 and 7 |
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| Secondary | Part 1: Absolute Values of Vital Signs: Pulse Rate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7 |
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| Secondary | Part 2: Absolute Values of Vital Signs: Pulse Rate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7 |
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| Secondary | Part 1: Absolute Values of Vital Signs: Oral Temperature | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Degrees celsius | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7 |
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| Secondary | Part 2: Absolute Values of Vital Signs: Oral Temperature | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Degree celsius | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7 |
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| Secondary | Part 1: Absolute Values of Vital Signs: Respiratory Rate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Breaths per minute | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7 |
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| Secondary | Part 2: Absolute Values of Vital Signs: Respiratory Rate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Breaths per minute | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7 |
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| Secondary | Part 1: Change From Baseline in Vital Signs: DBP and SBP | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7 |
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| Secondary | Part 2: Change From Baseline in Vital Signs: DBP and SBP | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7 |
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| Secondary | Part 1: Change From Baseline in Vital Signs: Pulse Rate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7 |
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| Secondary | Part 2: Change From Baseline in Vital Signs: Pulse Rate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7 |
|
|
|
| Secondary | Part 1: Change From Baseline in Vital Signs: Oral Temperature | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7 |
|
|
|
| Secondary | Part 2: Change From Baseline in Vital Signs: Oral Temperature | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, 6 and 7 |
|
|
|
| Secondary | Part 1: Change From Baseline in Vital Signs: Respiratory Rate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Breaths per minute | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7 |
|
|
|
| Secondary | Part 2: Change From Baseline in Vital Signs: Respiratory Rate | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Breaths per minute | Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7 |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet) | Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 monolayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG002 | Part 1:Treatment C:GSK3640254/DTG 150/50mg(Bilayer Tablet) | Participants received a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 bilayer tablet) FDC under moderate fat and calorie conditions on Day 1 in treatment period 1, 2 and 3. | 0 | 20 | 0 | 20 | 1 | 20 |
| EG003 | Part 2: Treatment D: GSK3640254/DTG, 150 mg/50 mg (Fed) | Participants received Treatment D a single oral dose of selected bilayer FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg under high fat and calorie conditions on Day 1 in each treatment period. | 0 | 17 | 0 | 17 | 1 | 17 |
| EG004 | Part 2: Treatment E: GSK3640254/DTG, 150 mg/50 mg (Fasted) | Participants received Treatment E a single oral dose of selected bilayer FDC from Part 1 GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions on Day 1 in each treatment period. | 0 | 18 | 0 | 18 | 2 | 18 |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Ratio of geometric Least Square mean |
| 1.055 |
| 2-Sided |
| 90 |
| 0.9278 |
| 1.201 |
An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t). |
| Other |
| Ratio of geometric Least Square mean |
| 1.020 |
| 2-Sided |
| 90 |
| 0.9049 |
| 1.151 |
An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax. |
| Other |
| Ratio of geometric Least Square mean |
| 1.112 |
| 2-Sided |
| 90 |
| 1.050 |
| 1.178 |
An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf). |
| Other |
| Ratio of geometric Least Square mean |
| 1.087 |
| 2-Sided |
| 90 |
| 0.9975 |
| 1.184 |
An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t). |
| Other |
| Ratio of geometric Least Square mean |
| 1.032 |
| 2-Sided |
| 90 |
| 0.9914 |
| 1.075 |
An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax |
| Other |
| Title | Measurements |
|---|---|
|
| Basophils, Day 2 |
|
|
| Basophils, Day 5 |
|
|
| Basophils, Day 7 |
|
|
| Eosinophils, Baseline (Day -1) |
|
|
| Eosinophils, Day 2 |
|
|
| Eosinophils, Day 5 |
|
|
| Eosinophils, Day 7 |
|
|
| Lymphocytes, Baseline (Day -1) |
|
|
| Lymphocytes, Day 2 |
|
|
| Lymphocytes, Day 5 |
|
|
| Lymphocytes, Day 7 |
|
|
| Monocytes, Baseline (Day -1) |
|
|
| Monocytes, Day 2 |
|
|
| Monocytes, Day 5 |
|
|
| Monocytes, Day 7 |
|
|
| Neutrophils, Baseline (Day -1) |
|
|
| Neutrophils, Day 2 |
|
|
| Neutrophils, Day 5 |
|
|
| Neutrophils, Day 7 |
|
|
| Platelets, Baseline (Day -1) |
|
|
| Platelets, Day 2 |
|
|
| Platelets, Day 5 |
|
|
| Platelets, Day 7 |
|
|
| Basophils, Day 2 |
|
|
| Basophils, Day 5 |
|
|
| Basophils, Day 7 |
|
|
| Eosinophils, Baseline (Day -1) |
|
|
| Eosinophils, Day 2 |
|
|
| Eosinophils, Day 5 |
|
|
| Eosinophils, Day 7 |
|
|
| Lymphocytes, Baseline (Day -1) |
|
|
| Lymphocytes, Day 2 |
|
|
| Lymphocytes, Day 5 |
|
|
| Lymphocytes, Day 7 |
|
|
| Monocytes, Baseline (Day -1) |
|
|
| Monocytes, Day 2 |
|
|
| Monocytes, Day 5 |
|
|
| Monocytes, Day 7 |
|
|
| Neutrophils, Baseline (Day -1) |
|
|
| Neutrophils, Day 2 |
|
|
| Neutrophils, Day 5 |
|
|
| Neutrophils, Day 7 |
|
|
| Platelets, Baseline (Day -1) |
|
|
| Platelets, Day 2 |
|
|
| Platelets, Day 5 |
|
|
| Platelets, Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Basophils, Day 5 |
|
|
| Basophils, Day 7 |
|
|
| Eosinophils, Day 2 |
|
|
| Eosinophils, Day 5 |
|
|
| Eosinophils, Day 7 |
|
|
| Lymphocytes, Day 2 |
|
|
| Lymphocytes, Day 5 |
|
|
| Lymphocytes, Day 7 |
|
|
| Monocytes, Day 2 |
|
|
| Monocytes, Day 5 |
|
|
| Monocytes, Day 7 |
|
|
| Neutrophils, Day 2 |
|
|
| Neutrophils, Day 5 |
|
|
| Neutrophils, Day 7 |
|
|
| Platelets, Day 2 |
|
|
| Platelets, Day 5 |
|
|
| Platelets, Day 7 |
|
|
| Basophils, Day 5 |
|
|
| Basophils, Day 7 |
|
|
| Eosinophils, Day 2 |
|
|
| Eosinophils, Day 5 |
|
|
| Eosinophils, Day 7 |
|
|
| Lymphocytes, Day 2 |
|
|
| Lymphocytes, Day 5 |
|
|
| Lymphocytes, Day 7 |
|
|
| Monocytes, Day 2 |
|
|
| Monocytes, Day 5 |
|
|
| Monocytes, Day 7 |
|
|
| Neutrophils, Day 2 |
|
|
| Neutrophils, Day 5 |
|
|
| Neutrophils, Day 7 |
|
|
| Platelets, Day 2 |
|
|
| Platelets, Day 5 |
|
|
| Platelets, Day 7 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| ALT, Day 2 |
|
|
| ALT, Day 5 |
|
|
| ALT, Day 7 |
|
|
| ALP, Baseline (Day -1) |
|
|
| ALP, Day 2 |
|
|
| ALP, Day 5 |
|
|
| ALP, Day 7 |
|
|
| AST, Baseline (Day -1) |
|
|
| AST, Day 2 |
|
|
| AST, Day 5 |
|
|
| AST, Day 7 |
|
|
| GGT, Baseline (Day -1) |
|
|
| GGT, Day 2 |
|
|
| GGT, Day 5 |
|
|
| GGT, Day 7 |
|
|
| LDH, Baseline (Day -1) |
|
|
| LDH, Day 2 |
|
|
| LDH, Day 5 |
|
|
| LDH, Day 7 |
|
|
| CK, Baseline (Day -1) |
|
|
| CK, Day 2 |
|
|
| CK, Day 5 |
|
|
| CK, Day 7 |
|
|
| ALT, Day 2 |
|
|
| ALT, Day 5 |
|
|
| ALT, Day 7 |
|
|
| ALP Baseline (Day -1) |
|
|
| ALP, Day 2 |
|
|
| ALP, Day 5 |
|
|
| ALP, Day 7 |
|
|
| AST, Baseline (Day -1) |
|
|
| AST, Day 2 |
|
|
| AST, Day 5 |
|
|
| AST, Day 7 |
|
|
| GGT, Baseline (Day -1) |
|
|
| GGT, Day 2 |
|
|
| GGT, Day 5 |
|
|
| GGT, Day 7 |
|
|
| LDH, Baseline (Day -1) |
|
|
| LDH, Day 2 |
|
|
| LDH, Day 5 |
|
|
| LDH, Day 7 |
|
|
| CK, Baseline (Day -1) |
|
|
| CK, Day 2 |
|
|
| CK, Day 5 |
|
|
| CK, Day 7 |
|
|
| Calcium, Day 2 |
|
|
| Calcium, Day 5 |
|
|
| Calcium, Day 7 |
|
|
| CO2, Baseline (Day -1) |
|
|
| CO2, Day 2 |
|
|
| CO2, Day 5 |
|
|
| CO2, Day 7 |
|
|
| Chloride, Baseline (Day -1) |
|
|
| Chloride, Day 2 |
|
|
| Chloride, Day 5 |
|
|
| Chloride, Day 7 |
|
|
| Glucose, Baseline (Day -1) |
|
|
| Glucose, Day 2 |
|
|
| Glucose, Day 5 |
|
|
| Glucose, Day 7 |
|
|
| Potassium, Baseline (Day -1) |
|
|
| Potassium, Day 2 |
|
|
| Potassium, Day 5 |
|
|
| Potassium, Day 7 |
|
|
| Sodium, Baseline (Day -1) |
|
|
| Sodium, Day 2 |
|
|
| Sodium, Day 5 |
|
|
| Sodium, Day 7 |
|
|
| Urea nitrogen, Baseline (Day -1) |
|
|
| Urea nitrogen, Day 2 |
|
|
| Urea nitrogen, Day 5 |
|
|
| Urea nitrogen, Day 7 |
|
|
| Phosphate, Baseline (Day -1) |
|
|
| Phosphate, Day 2 |
|
|
| Phosphate, Day 5 |
|
|
| Phosphate, Day 7 |
|
|
| Triglycerides, Baseline (Day -1) |
|
|
| Triglycerides, Day 2 |
|
|
| Triglycerides, Day 5 |
|
|
| Triglycerides Day 7 |
|
|
| Cholesterol, Baseline (Day -1) |
|
|
| Cholesterol, Day 2 |
|
|
| Cholesterol, Day 5 |
|
|
| Cholesterol, Day 7 |
|
|
| Anion gap, Baseline (Day -1) |
|
|
| Anion gap, Day 2 |
|
|
| Anion gap, Day 5 |
|
|
| Anion gap, Day 7 |
|
|
| Calcium, Day 2 |
|
|
| Calcium, Day 5 |
|
|
| Calcium, Day 7 |
|
|
| CO2, Baseline (Day -1) |
|
|
| CO2, Day 2 |
|
|
| CO2, Day 5 |
|
|
| CO2, Day 7 |
|
|
| Chloride, Baseline (Day -1) |
|
|
| Chloride, Day 2 |
|
|
| Chloride, Day 5 |
|
|
| Chloride, Day 7 |
|
|
| Glucose, Baseline (Day -1) |
|
|
| Glucose, Day 2 |
|
|
| Glucose, Day 5 |
|
|
| Glucose, Day 7 |
|
|
| Potassium, Baseline (Day -1) |
|
|
| Potassium, Day 2 |
|
|
| Potassium, Day 5 |
|
|
| Potassium, Day 7 |
|
|
| Sodium, Baseline (Day -1) |
|
|
| Sodium, Day 2 |
|
|
| Sodium, Day 5 |
|
|
| Sodium, Day 7 |
|
|
| Urea nitrogen, Baseline (Day -1) |
|
|
| Urea nitrogen, Day 2 |
|
|
| Urea nitrogen, Day 5 |
|
|
| Urea nitrogen, Day 7 |
|
|
| Phosphate, Baseline (Day -1) |
|
|
| Phosphate, Day 2 |
|
|
| Phosphate, Day 5 |
|
|
| Phosphate, Day 7 |
|
|
| Triglycerides, Baseline (Day -1) |
|
|
| Triglycerides, Day 2 |
|
|
| Triglycerides, Day 5 |
|
|
| Triglycerides, Day 7 |
|
|
| Cholesterol, Baseline (Day -1) |
|
|
| Cholesterol, Day 2 |
|
|
| Cholesterol, Day 5 |
|
|
| Cholesterol, Day 7 |
|
|
| Anion Gap, Baseline (Day -1) |
|
|
| Anion Gap, Day 2 |
|
|
| Anion Gap, Day 5 |
|
|
| Anion Gap, Day 7 |
|
|
| Serum lipase, Day 2 |
|
|
| Serum lipase, Day 5 |
|
|
| Serum lipase, Day 7 |
|
|
| Serum amylase, Baseline (Day -1) |
|
|
| Serum amylase, Day 2 |
|
|
| Serum amylase, Day 5 |
|
|
| Serum amylase, Day 7 |
|
|
| Serum lipase, Day 2 |
|
|
| Serum lipase, Day 5 |
|
|
| Serum lipase, Day 7 |
|
|
| Serum amylase, Baseline (Day -1) |
|
|
| Serum amylase, Day 2 |
|
|
| Serum amylase, Day 5 |
|
|
| Serum amylase, Day 7 |
|
|
| Albumin, Day 2 |
|
|
| Albumin, Day 5 |
|
|
| Albumin, Day 7 |
|
|
| Globulin, Baseline (Day -1) |
|
|
| Globulin, Day 2 |
|
|
| Globulin, Day 5 |
|
|
| Globulin, Day 7 |
|
|
| Protein, Baseline (Day -1) |
|
|
| Protein, Day 2 |
|
|
| Protein, Day 5 |
|
|
| Protein, Day 7 |
|
|
| Albumin, Day 2 |
|
|
| Albumin, Day 5 |
|
|
| Albumin, Day 7 |
|
|
| Globulin, Baseline (Day -1) |
|
|
| Globulin, Day 2 |
|
|
| Globulin, Day 5 |
|
|
| Globulin, Day 7 |
|
|
| Protein, Baseline (Day -1) |
|
|
| Protein, Day 2 |
|
|
| Protein, Day 5 |
|
|
| Protein, Day 7 |
|
|
| Creatinine, Day 2 |
|
|
| Creatinine, Day 5 |
|
|
| Creatinine, Day 7 |
|
|
| Direct bilirubin, Baseline (Day -1) |
|
|
| Direct bilirubin, Day 2 |
|
|
| Direct bilirubin, Day 5 |
|
|
| Direct bilirubin, Day 7 |
|
|
| Bilirubin, Baseline (Day -1) |
|
|
| Bilirubin, Day 2 |
|
|
| Bilirubin, Day 5 |
|
|
| Bilirubin, Day 7 |
|
|
| Urate, Baseline (Day -1) |
|
|
| Urate, Day 2 |
|
|
| Urate, Day 5 |
|
|
| Urate, Day 7 |
|
|
| Creatinine, Day 2 |
|
|
| Creatinine, Day 5 |
|
|
| Creatinine, Day 7 |
|
|
| Direct bilirubin, Baseline (Day -1) |
|
|
| Direct bilirubin, Day 2 |
|
|
| Direct bilirubin, Day 5 |
|
|
| Direct bilirubin, Day 7 |
|
|
| Bilirubin, Baseline (Day -1) |
|
|
| Bilirubin, Day 2 |
|
|
| Bilirubin, Day 5 |
|
|
| Bilirubin, Day 7 |
|
|
| Urate, Baseline (Day -1) |
|
|
| Urate, Day 2 |
|
|
| Urate, Day 5 |
|
|
| Urate, Day 7 |
|
|
| ALT, Day 5 |
|
|
| ALT, Day 7 |
|
|
| ALP, Day 2 |
|
|
| ALP, Day 5 |
|
|
| ALP, Day 7 |
|
|
| AST, Day 2 |
|
|
| AST, Day 5 |
|
|
| AST, Day 7 |
|
|
| GGT, Day 2 |
|
|
| GGT, Day 5 |
|
|
| GGT, Day 7 |
|
|
| LDH, Day 2 |
|
|
| LDH, Day 5 |
|
|
| LDH, Day 7 |
|
|
| CK, Day 2 |
|
|
| CK, Day 5 |
|
|
| CK, Day 7 |
|
|
| ALT, Day 5 |
|
|
| ALT, Day 7 |
|
|
| ALP, Day 2 |
|
|
| ALP, Day 5 |
|
|
| ALP, Day 7 |
|
|
| AST, Day 2 |
|
|
| AST, Day 5 |
|
|
| AST, Day 7 |
|
|
| GGT, Day 2 |
|
|
| GGT, Day 5 |
|
|
| GGT, Day 7 |
|
|
| LDH, Day 2 |
|
|
| LDH, Day 5 |
|
|
| LDH, Day 7 |
|
|
| CK, Day 2 |
|
|
| CK, Day 5 |
|
|
| CK, Day 7 |
|
|
| Calcium, Day 5 |
|
|
| Calcium, Day 7 |
|
|
| CO2, Day 2 |
|
|
| CO2, Day 5 |
|
|
| CO2, Day 7 |
|
|
| Chloride, Day 2 |
|
|
| Chloride, Day 5 |
|
|
| Chloride, Day 7 |
|
|
| Glucose, Day 2 |
|
|
| Glucose, Day 5 |
|
|
| Glucose, Day 7 |
|
|
| Potassium, Day 2 |
|
|
| Potassium, Day 5 |
|
|
| Potassium, Day 7 |
|
|
| Sodium, Day 2 |
|
|
| Sodium, Day 5 |
|
|
| Sodium, Day 7 |
|
|
| Urea nitrogen, Day 2 |
|
|
| Urea nitrogen, Day 5 |
|
|
| Urea nitrogen, Day 7 |
|
|
| Phosphate, Day 2 |
|
|
| Phosphate, Day 5 |
|
|
| Phosphate, Day 7 |
|
|
| Triglycerides, Day 2 |
|
|
| Triglycerides, Day 5 |
|
|
| Triglycerides, Day 7 |
|
|
| Cholesterol, Day 2 |
|
|
| Cholesterol, Day 5 |
|
|
| Cholesterol, Day 7 |
|
|
| Anion gap, Day 2 |
|
|
| Anion gap, Day 5 |
|
|
| Anion gap, Day 7 |
|
|
| Calcium, Day 5 |
|
|
| Calcium, Day 7 |
|
|
| CO2, Day 2 |
|
|
| CO2, Day 5 |
|
|
| CO2, Day 7 |
|
|
| Chloride, Day 2 |
|
|
| Chloride, Day 5 |
|
|
| Chloride, Day 7 |
|
|
| Glucose, Day 2 |
|
|
| Glucose, Day 5 |
|
|
| Glucose, Day 7 |
|
|
| Potassium, Day 2 |
|
|
| Potassium, Day 5 |
|
|
| Potassium, Day 7 |
|
|
| Sodium, Day 2 |
|
|
| Sodium, Day 5 |
|
|
| Sodium, Day 7 |
|
|
| Urea nitrogen, Day 2 |
|
|
| Urea nitrogen, Day 5 |
|
|
| Urea nitrogen, Day 7 |
|
|
| Phosphate, Day 2 |
|
|
| Phosphate, Day 5 |
|
|
| Phosphate, Day 7 |
|
|
| Triglycerides, Day 2 |
|
|
| Triglycerides, Day 5 |
|
|
| Triglycerides, Day 7 |
|
|
| Cholesterol, Day 2 |
|
|
| Cholesterol, Day 5 |
|
|
| Cholesterol, Day 7 |
|
|
| Anion gap, Day 2 |
|
|
| Anion gap, Day 5 |
|
|
| Anion gap, Day 7 |
|
|
| Lipase, Day 5 |
|
|
| Lipase, Day 7 |
|
|
| Amylase, Day 2 |
|
|
| Amylase, Day 5 |
|
|
| Amylase, Day 7 |
|
|
| Lipase, Day 5 |
|
|
| Lipase, Day 7 |
|
|
| Amylase, Day 2 |
|
|
| Amylase, Day 5 |
|
|
| Amylase, Day 7 |
|
|
| Albumin, Day 5 |
|
|
| Albumin, Day 7 |
|
|
| Globulin, Day 2 |
|
|
| Globulin, Day 5 |
|
|
| Globulin, Day 7 |
|
|
| Protein, Day 2 |
|
|
| Protein, Day 5 |
|
|
| Protein, Day 7 |
|
|
| Albumin, Day 5 |
|
|
| Albumin, Day 7 |
|
|
| Globulin, Day 2 |
|
|
| Globulin, Day 5 |
|
|
| Globulin, Day 7 |
|
|
| Protein, Day 2 |
|
|
| Protein, Day 5 |
|
|
| Protein, Day 7 |
|
|
| Creatinine, Day 5 |
|
|
| Creatinine, Day 7 |
|
|
| Direct bilirubin, Day 2 |
|
|
| Direct bilirubin, Day 5 |
|
|
| Direct bilirubin, Day 7 |
|
|
| Bilirubin, Day 2 |
|
|
| Bilirubin, Day 5 |
|
|
| Bilirubin, Day 7 |
|
|
| Urate, Day 2 |
|
|
| Urate, Day 5 |
|
|
| Urate, Day 7 |
|
|
| Creatinine, Day 5 |
|
|
| Creatinine, Day 7 |
|
|
| Direct bilirubin, Day 2 |
|
|
| Direct bilirubin, Day 5 |
|
|
| Direct bilirubin, Day 7 |
|
|
| Bilirubin, Day 2 |
|
|
| Bilirubin, Day 5 |
|
|
| Bilirubin, Day 7 |
|
|
| Urate, Day 2 |
|
|
| Urate, Day 5 |
|
|
| Urate, Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 2 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 2, Negative |
|
|
| Day 5, Negative |
|
|
| Day 7, Negative |
|
|
| Day 2, Negative |
|
|
| Day 5, Negative |
|
|
| Day 7, Negative |
|
|
| Day 2, Negative |
|
|
| Day 5, Negative |
|
|
| Day 7, Negative |
|
|
| Day 7, Trace |
|
|
| Day 2, Negative |
|
|
| Day 5, Negative |
|
|
| Day 7, Negative |
|
|
| Day 7, Trace |
|
|
| Baseline (Day -1), Trace |
|
|
| Baseline (Day -1), 2+ |
|
|
| Day 2, Negative |
|
|
| Day 2, Trace |
|
|
| Day 2, 1+ |
|
|
| Day 2, 2+ |
|
|
| Day 2, 3+ |
|
|
| Day 5, Negative |
|
|
| Day 5, 1+ |
|
|
| Day 5, 2+ |
|
|
| Day 7, Negative |
|
|
| Day 7, Trace |
|
|
| Baseline (Day -1), Trace |
|
|
| Baseline (Day -1), 1+ |
|
|
| Baseline (Day -1), 2+ |
|
|
| Day 2, Negative |
|
|
| Day 2, 1+ |
|
|
| Day 5, Negative |
|
|
| Day 5, Trace |
|
|
| Day 7, Negative |
|
|
| Day 7, 1+ |
|
|
| Day 7, 2+ |
|
|
| Baseline (Day -1), Trace |
|
|
| Day 2, Negative |
|
|
| Day 2, Trace |
|
|
| Day 5, Negative |
|
|
| Day 5, 2+ |
|
|
| Day 7, Negative |
|
|
| Day 7, Trace |
|
|
| Baseline (Day -1), Trace |
|
|
| Day 2, Negative |
|
|
| Day 2, 1+ |
|
|
| Day 5, Negative |
|
|
| Day 5, Trace |
|
|
| Day 5, 2+ |
|
|
| Day 7, Negative |
|
|
| Day 7, Trace |
|
|
| Bilirubin, Day 2, Negative |
|
|
| Bilirubin, Day 5, Negative |
|
|
| Bilirubin, Day 7, Negative |
|
|
| Nitrite, Baseline (Day -1), Negative |
|
|
| Nitrite, Day 2, Negative |
|
|
| Nitrite, Day 5, Negative |
|
|
| Nitrite, Day 7, Negative |
|
|
| Bilirubin, Day 2, Negative |
|
|
| Bilirubin, Day 5, Negative |
|
|
| Bilirubin, Day 7, Negative |
|
|
| Nitrite, Baseline (Day -1), Negative |
|
|
| Nitrite, Day 2, Negative |
|
|
| Nitrite, Day 5, Negative |
|
|
| Nitrite, Day 7, Negative |
|
|
| Baseline (Day -1), Trace |
|
|
| Day 2, Negative |
|
|
| Day 2, 1+ |
|
|
| Day 5, Negative |
|
|
| Day 5, 1+ |
|
|
| Day 7, Negative |
|
|
| Day 7, Trace |
|
|
| Day 7, 1+ |
|
|
| Baseline (Day -1), Trace |
|
|
| Day 2, Negative |
|
|
| Day 2, Trace |
|
|
| Day 5, Negative |
|
|
| Day 7, Negative |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Title | Measurements |
|---|---|
|
| Increase to Grade 3 |
|
| Increase to Grade 4 |
|
| Increase to Grade 3 |
|
| Increase to Grade 4 |
|
| Title | Measurements |
|---|---|
|
| Increase to Grade 3 |
|
| Increase to Grade 4 |
|
| Increase to Grade 3 |
|
| Increase to Grade 4 |
|
| Title | Measurements |
|---|---|
|
| Increase to Grade 3 |
|
| Increase to Grade 4 |
|
| Increase to Grade 3 |
|
| Increase to Grade 4 |
|
| PR Interval, Day 1, 2 hours |
|
|
| PR Interval, Day 1, 4 hours |
|
|
| PR Interval, Day 1, 6 hours |
|
|
| PR Interval, Day 5 |
|
|
| QRS Duration, Baseline (Day 1) |
|
|
| QRS Duration, Day 1, 2 hours |
|
|
| QRS Duration, Day 1, 4 hours |
|
|
| QRS Duration, Day 1, 6 hours |
|
|
| QRS Duration, Day 5 |
|
|
| QT Interval, Baseline (Day 1) |
|
|
| QT Interval, Day 1, 2 hours |
|
|
| QT Interval, Day 1, 4 hours |
|
|
| QT Interval, Day 1, 6 hours |
|
|
| QT Interval, Day 5 |
|
|
| QTcF Interval, Baseline (Day 1) |
|
|
| QTcF Interval, Day 1, 2 hours |
|
|
| QTcF Interval, Day 1, 4 hours |
|
|
| QTcF Interval, Day 1, 6 hours |
|
|
| QTcF Interval, Day 5 |
|
|
| PR Interval, Day 1, 2 hours |
|
|
| PR Interval, Day 1, 4 hours |
|
|
| PR Interval, Day 1, 6 hours |
|
|
| PR Interval, Day 5 |
|
|
| PR Interval, Day 7 |
|
|
| QRS Duration, Baseline (Day 1) |
|
|
| QRS Duration, Day 1, 2 hours |
|
|
| QRS Duration, Day 1, 4 hours |
|
|
| QRS Duration, Day 1, 6 hours |
|
|
| QRS Duration, Day 5 |
|
|
| QRS Duration, Day 7 |
|
|
| QT Interval, Baseline (Day 1) |
|
|
| QT Interval, Day 1, 2 hours |
|
|
| QT Interval, Day 1, 4 hours |
|
|
| QT Interval, Day 1, 6 hours |
|
|
| QT Interval, Day 5 |
|
|
| QT Interval, Day 7 |
|
|
| QTcF Interval, Baseline (Day 1) |
|
|
| QTcF Interval, Day 1, 2 hours |
|
|
| QTcF Interval, Day 1, 4 hours |
|
|
| QTcF Interval, Day 1, 6 hours |
|
|
| QTcF Interval, Day 5 |
|
|
| QTcF Interval, Day 7 |
|
|
| PR Interval, Day 1, 4 hours |
|
|
| PR Interval, Day 1, 6 hours |
|
|
| PR Interval, Day 5 |
|
|
| QRS Duration, Day 1, 2 hours |
|
|
| QRS Duration, Day 1, 4 hours |
|
|
| QRS Duration, Day 1, 6 hours |
|
|
| QRS Duration, Day 5 |
|
|
| QT Interval, Day 1, 2 hours |
|
|
| QT Interval, Day 1, 4 hours |
|
|
| QT Interval, Day 1, 6 hours |
|
|
| QT Interval, Day 5 |
|
|
| QTcF Interval, Day 1, 2 hours |
|
|
| QTcF Interval, Day 1, 4 hours |
|
|
| QTcF Interval, Day 1, 6 hours |
|
|
| QTcF Interval, Day 5 |
|
|
| PR Interval, Day 1, 4 hours |
|
|
| PR Interval, Day 1, 6 hours |
|
|
| PR Interval, Day 5 |
|
|
| PR Interval, Day 7 |
|
|
| QRS Duration, Day 1, 2 hours |
|
|
| QRS Duration, Day 1, 4 hours |
|
|
| QRS Duration Day 1, 6 hours |
|
|
| QRS Duration, Day 5 |
|
|
| QRS Duration, Day 7 |
|
|
| QT Interval, Day 1, 2 hours |
|
|
| QT Interval, Day 1, 4 hours |
|
|
| QT Interval, Day 1, 6 hours |
|
|
| QT Interval, Day 5 |
|
|
| QT Interval, Day 7 |
|
|
| QTcF Interval, Day 1, 2 hours |
|
|
| QTcF Interval, Day 1, 4 hours |
|
|
| QTcF Interval, Day 1, 6 hours |
|
|
| QTcF Interval, Day 5 |
|
|
| QTcF Interval, Day 7 |
|
|
| DBP, Day 1, 24 hours |
|
|
| DBP, Day 1, 48 hours |
|
|
| DBP, Day 1, 72 hours |
|
|
| DBP, Day 5 |
|
|
| DBP Interval, Day 7 |
|
|
| SBP, Baseline (Day 1) |
|
|
| SBP, Day 1, 24 hours |
|
|
| SBP, Day 1, 48 hours |
|
|
| SBP, Day 1, 72 hours |
|
|
| SBP, Day 5 |
|
|
| SBP, Day 7 |
|
|
| DBP, Day 1, 24 hours |
|
|
| DBP, Day 1, 48 hours |
|
|
| DBP, Day 5 |
|
|
| DBP Interval, Day 7 |
|
|
| SBP, Baseline (Day 1 pre-dose) |
|
|
| SBP, Day 1, 24 hours |
|
|
| SBP, Day 1, 48 hours |
|
|
| SBP, Day 5 |
|
|
| SBP, Day 7 |
|
|
| Day 1, 24 hours |
|
|
| Day 1, 48 hours |
|
|
| Day 1, 72 hours |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 1, 24 hours |
|
|
| Day 1, 48 hours |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 1, 24 hours |
|
|
| Day 1, 48 hours |
|
|
| Day 1, 72 hours |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| Day 1, 24 hours |
|
|
| Day 1, 48 hours |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| Day 1, 24 hours |
|
|
| Day 1, 48 hours |
|
|
| Day 1, 72 hours |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 1, 24 hours |
|
|
| Day 1, 48 hours |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| DBP, Day 1, 48 hours |
|
|
| DBP, Day 1, 72 hours |
|
|
| DBP, Day 5 |
|
|
| DBP, Day 7 |
|
|
| SBP, Day 1, 24 hours |
|
|
| SBP, Day 1, 48 hours |
|
|
| SBP, Day 1, 72 hours |
|
|
| SBP, Day 5 |
|
|
| SBP, Day 7 |
|
|
| DBP, Day 1, 48 hours |
|
|
| DBP, Day 5 |
|
|
| DBP Interval, Day 7 |
|
|
| SBP, Day 1, 24 hours |
|
|
| SBP, Day 1, 48 hours |
|
|
| SBP, Day 5 |
|
|
| SBP, Day 7 |
|
|
| Day 1, 48 hours |
|
|
| Day 1, 72 hours |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 1, 48 hours |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 1, 48 hours |
|
|
| Day 1, 72 hours |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| Day 1, 48 hours |
|
|
| Day 5 |
|
|
| Day 6 |
|
|
| Day 7 |
|
|
| Day 1, 48 hours |
|
|
| Day 1, 72 hours |
|
|
| Day 5 |
|
|
| Day 7 |
|
|
| Day 1, 48 hours |
|
|
| Day 5 |
|
|
| Day 7 |
|
|