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This is an open-label, single-sequence, two-way drug interaction study to investigate the PK, safety and tolerability of GSK3640254 and DTG when administered alone or in combination in healthy subjects. Treatment of human immunodeficiency virus (HIV) infection frequently involves combination therapy. Data from this study will contribute to dosing recommendations when GSK3640254 and DTG are given in combination. The study will consist of a Screening period and 3 sequential treatment periods. Subjects will be administered DTG 50 milligrams (mg) once daily (QD) in Period 1 followed by GSK3640254 200 mg QD in Period 2. There will be a washout period of 4 days between Periods 1 and 2. In Period 3, subjects will be co-administered DTG 50 mg QD and GSK3640254 200 mg QD. The total duration of the study will be approximately 55 days, including Screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTG followed by GSK3640254 followed by DTG+GSK3640254 | Experimental | Subjects will receive DTG 50 mg QD on Days 1 through 5 in Period 1 followed by a wash-out period of 4 days. Subjects will then receive GSK3640254 200 mg QD on Days 1 through 7 in Period 2 followed by co-administration of DTG 50 mg QD with GSK3640254 200 mg QD on Days 1 through 7 in Period 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3640254 | Drug | GSK3640254 will be available as 100 mg capsules. Subjects will be administered GSK3640254 200 mg QD via the oral route. |
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| Measure | Description | Time Frame |
|---|---|---|
| Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing (AUC[0 to Tau]) of Dolutegravir for Dolutegravir Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic Parameter Population consisted of all participants who underwent plasma pharmacokinetic sampling and had evaluable pharmacokinetic parameters estimated. | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 3: AUC(0 to Tau) of Dolutegravir for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 1: Maximum Observed Concentration (Cmax) of Dolutegravir for Dolutegravir Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 3: Cmax of Dolutegravir for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of Dolutegravir for Dolutegravir Arm |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (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. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication. |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33533507 | Derived | Pene Dumitrescu T, Joshi SR, Xu J, Greene TJ, Johnson M, Butcher L, Zimmerman E, Webster L, Pham TT, Lataillade M, Min S. Phase I evaluation of pharmacokinetics and tolerability of the HIV-1 maturation inhibitor GSK3640254 and dolutegravir in healthy adults. Br J Clin Pharmacol. 2021 Sep;87(9):3501-3507. doi: 10.1111/bcp.14759. Epub 2021 Mar 4. |
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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 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 30 participants were screened, of which 14 were screening failures. Hence, 16 participants were enrolled in this study. This study was conducted at a single center in the United States.
This was an open-label, fixed-sequence, two-way drug interaction and 3-period study. Participants received treatment A- dolutegravir 50 milligram (mg) in Period 1; treatment B- GSK3640254 200 mg in Period 2 and treatment C- dolutegravir 50 mg and GSK3640254 200 mg in Period 3.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dolutegravir/GSK3640254/Dolutegravir+GSK3640254 | Participants received treatment A- dolutegravir 50 mg, tablets, orally, once daily on Days 1 to 5 in Period 1; followed by washout period of 4 days between last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2; followed by treatment B- GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 2; further followed by treatment C- dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Up to Day 5) |
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| Wash Out Period (Days 6 to 9) |
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| Period 2 (Up to Day 7) |
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| Period 3 (Up to Day 11) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dolutegravir/GSK3640254/Dolutegravir+GSK3640254 | Participants received treatment A- dolutegravir 50 mg, tablets, orally, once daily on Days 1 to 5 in Period 1; followed by washout period of 4 days between last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2; followed by treatment B- GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 2; further followed by treatment C- dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally, once daily on Days 1 to 7 in Period 3. |
| 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, Continuous | Mean |
| 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 | Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing (AUC[0 to Tau]) of Dolutegravir for Dolutegravir Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic Parameter Population consisted of all participants who underwent plasma pharmacokinetic sampling and had evaluable pharmacokinetic parameters estimated. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours* nanogram per milliliter | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
|
Non-SAEs and SAEs were collected from start of the study treatment up to Day 27
Safety Population consisted of all participants who received at least 1 dose of study medication.
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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 | Dolutegravir 50 mg | In Period 1, participants received dolutegravir 50 mg, tablets, orally (treatment A) once daily on Days 1 through 5 followed by a wash-out period of 4 days. A wash out period was maintained between the last dose of study treatment A in Period 1 and initiation of study treatment B in Period 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | 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 | Dec 12, 2018 | Feb 25, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2019 | Feb 25, 2020 | 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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| DTG | Drug | DTG will be available as 50 mg tablets. Subjects will be administered DTG 50 mg QD via the oral route. |
|
Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
| Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 3: Ctau of Dolutegravir for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 2: AUC(0 to Tau) of GSK3640254 for GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 3: AUC(0 to Tau) of GSK3640254 for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 2: Cmax of GSK3640254 for GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 3: Cmax of GSK3640254 for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 2: Ctau of GSK3640254 for GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 3: Ctau of GSK3640254 for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Up to Day 27 |
| Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 1: Change From Baseline in Hematology Parameter: 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 2: Change From Baseline in Hematology Parameter: 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: Change From Baseline in Hematology Parameter: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 1: Change From Baseline in Urinalysis Parameter: Urobilinogen | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 2: Change From Baseline in Urinalysis Parameter: Urobilinogen | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 1: Change From Baseline in Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day -1) and at Day 9 |
| Period 2: Change From Baseline in Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 1 Day 9) and at Day 7 |
| Period 3: Change From Baseline in Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
| Period 1: Number of Participants With Urinalysis Dipstick Results | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present) and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample. | Day 9 |
| Period 2: Number of Participants With Urinalysis Dipstick Results | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample. | Day 7 |
| Period 3: Number of Participants With Urinalysis Dipstick Results | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present)indicating proportional concentrations in the urine sample. | Days 4, 7 and 10 |
| Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | Twelve-lead electrocardiograms (ECG) were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline, Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours |
| Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline; Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours |
| Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline; Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10 |
| Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5 |
| Period 2: Change From Baseline in SBP and DBP | SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7 |
| Period 3: Change From Baseline in SBP and DBP | SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
| Period 1: Change From Baseline in Pulse Rate | Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5 |
| Period 2: Change From Baseline in Pulse Rate | Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7 |
| Period 3: Change From Baseline in Pulse Rate | Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
| Period 1: Change From Baseline in Respiratory Rate | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5 |
| Period 2: Change From Baseline in Respiratory Rate | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7 |
| Period 3: Change From Baseline in Respiratory Rate | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
| Period 1: Change From Baseline in Body Temperature | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5 |
| Period 2: Change From Baseline in Body Temperature | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7 |
| Period 3: Change From Baseline in Body Temperature | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
| Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. | Day 9 |
| Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. | Day 7 |
| Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. | Days 4, 7 and 10 |
| Period 1: Absolute Values for Hematology Parameter: Hemoglobin | Blood samples were collected to analyze the hematology parameter: hemoglobin. | Day 9 |
| Period 2: Absolute Values for Hematology Parameter: Hemoglobin | Blood samples were collected to analyze the hematology parameter: hemoglobin. | Day 7 |
| Period 3: Absolute Values for Hematology Parameter: Hemoglobin | Blood samples were collected to analyze the hematology parameter: hemoglobin. | Days 4, 7 and 10 |
| Period 1: Absolute Values for Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: hematocrit. | Day 9 |
| Period 2: Absolute Values for Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: hematocrit. | Day 7 |
| Period 3: Absolute Values for Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: hematocrit. | Days 4, 7 and 10 |
| Period 1: Absolute Values for Hematology Parameter: Erythrocytes | Blood samples were collected to analyze the hematology parameter: erythrocytes. | Day 9 |
| Period 2: Absolute Values for Hematology Parameter: Erythrocytes | Blood samples were collected to analyze the hematology parameter: erythrocytes. | Day 7 |
| Period 3: Absolute Values for Hematology Parameter: Erythrocytes | Blood samples were collected to analyze the hematology parameter: erythrocytes. | Days 4, 7 and 10 |
| Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. | Day 9 |
| Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. | Day 7 |
| Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. | Days 4, 7 and 10 |
| Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. | Day 9 |
| Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. | Day 7 |
| Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. | Days 4, 7 and 10 |
| Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. | Day 9 |
| Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. | Day 7 |
| Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. | Days 4, 7 and 10 |
| Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. | Day 9 |
| Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. | Day 7 |
| Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. | Days 4, 7 and 10 |
| Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. | Day 9 |
| Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. | Day 7 |
| Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. | Days 4, 7 and 10 |
| Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. | Day 9 |
| Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. | Day 7 |
| Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. | Days 4, 7 and 10 |
| Period 1: Absolute Values for Chemistry Parameters: Amylase, Lipase | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. | Day 9 |
| Period 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. | Day 7 |
| Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. | Days 4, 7 and 10 |
| Period 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. | Day 9 |
| Period 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. | Day 7 |
| Period 3: 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. | Days 4, 7 and 10 |
| Period 1: Absolute Values for Urinalysis Parameter: Urobilinogen | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. | Day 9 |
| Period 2: Absolute Values for Urinalysis Parameter: Urobilinogen | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. | Day 7 |
| Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. | Days 4, 7 and 10 |
| Period 1: Absolute Values for Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Day 9 |
| Period 2: Absolute Values for Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Day 7 |
| Period 3: Absolute Values for Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Days 4, 7 and 10 |
| Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. | Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours |
| Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. | Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours |
| Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. | Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10 |
| Period 1: Absolute Values for SBP and DBP | SBP and DBP were measured in the semi-recumbent position with a completely automated device. | Days 2, 3, 4 and 5 |
| Period 2: Absolute Values for SBP and DBP | SBP and DBP were measured in the semi-recumbent position with a completely automated device. | Days 2, 3, 4, 5, 6 and 7 |
| Period 3: Absolute Values for SBP and DBP | SBP and DBP were measured in the semi-recumbent position with a completely automated device. | Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
| Period 1: Absolute Values for Pulse Rate | Pulse rate was measured in the semi-recumbent position with a completely automated device. | Days 2, 3, 4 and 5 |
| Period 2: Absolute Values for Pulse Rate | Pulse rate was measured in the semi-recumbent position with a completely automated device. | Days 2, 3, 4, 5, 6 and 7 |
| Period 3: Absolute Values for Pulse Rate | Pulse rate was measured in the semi-recumbent position with a completely automated device. | Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
| Period 1: Absolute Values for Respiratory Rate | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. | Days 2, 3, 4 and 5 |
| Period 2: Absolute Values for Respiratory Rate | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. | Days 2, 3, 4, 5, 6 and 7 |
| Period 3: Absolute Values for Respiratory Rate | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. | Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
| Period 1: Absolute Values for Body Temperature | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. | Days 2, 3, 4 and 5 |
| Period 2: Absolute Values for Body Temperature | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. | Days 2, 3, 4, 5, 6 and 7 |
| Period 3: Absolute Values for Body Temperature | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. | Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
| Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 for GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 3: Tmax of GSK3640254 for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 2: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 for GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Data could not be determined due to limited sampling points after final dosing (during elimination phase). An accurate determination of GSK3640254 half-life would require sampling up to 3 times half-life (3 * approximately 24 hours). However sampling in Period 2 was performed up to only 24 hours post-dose. | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 3: T1/2 of GSK3640254 for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 1: Tmax of Dolutegravir for Dolutegravir Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 3: Tmax of Dolutegravir for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 1: T1/2 of Dolutegravir for Dolutegravir Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
| Period 3: T1/2 of Dolutegravir for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Primary | Period 3: AUC(0 to Tau) of Dolutegravir for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours* nanogram per milliliter | Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Primary | Period 1: Maximum Observed Concentration (Cmax) of Dolutegravir for Dolutegravir Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Primary | Period 3: Cmax of Dolutegravir for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Primary | Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of Dolutegravir for Dolutegravir Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Primary | Period 3: Ctau of Dolutegravir for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Primary | Period 2: AUC(0 to Tau) of GSK3640254 for GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours* microgram per milliliter | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Primary | Period 3: AUC(0 to Tau) of GSK3640254 for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours* microgram per milliliter | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Primary | Period 2: Cmax of GSK3640254 for GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Primary | Period 3: Cmax of GSK3640254 for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Primary | Period 2: Ctau of GSK3640254 for GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Primary | Period 3: Ctau of GSK3640254 for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Secondary | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (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. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 27 |
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| Secondary | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 1: Change From Baseline in Hematology Parameter: 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 2: Change From Baseline in Hematology Parameter: 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: Change From Baseline in Hematology Parameter: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Trillion cells per liter | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Trillion cells per liter | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Trillion cells per liter | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Femtoliter | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Femtoliter | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Femtoliter | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Picograms | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Picograms | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Picograms | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | International units per liter | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | International units per liter | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Units per liter | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Units per liter | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Units per liter | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 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 visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Ratio | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 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 visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Ratio | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: 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 visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Ratio | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 1: Change From Baseline in Urinalysis Parameter: Urobilinogen | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 2: Change From Baseline in Urinalysis Parameter: Urobilinogen | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 1: Change From Baseline in Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | pH | Baseline (Day -1) and at Day 9 |
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| Secondary | Period 2: Change From Baseline in Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | pH | Baseline (Period 1 Day 9) and at Day 7 |
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| Secondary | Period 3: Change From Baseline in Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | pH | Baseline (Period 2 Day 7) and at Days 4, 7 and 10 |
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| Secondary | Period 1: Number of Participants With Urinalysis Dipstick Results | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present) and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample. | Safety Population. | Posted | Count of Participants | Participants | Day 9 |
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| Secondary | Period 2: Number of Participants With Urinalysis Dipstick Results | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample. | Safety Population. | Posted | Count of Participants | Participants | Day 7 |
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| Secondary | Period 3: Number of Participants With Urinalysis Dipstick Results | Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present)indicating proportional concentrations in the urine sample. | Safety Population. | Posted | Count of Participants | Participants | Days 4, 7 and 10 |
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| Secondary | Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB) | Twelve-lead electrocardiograms (ECG) were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Milliseconds | Baseline, Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours |
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| Secondary | Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Milliseconds | Baseline; Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours |
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| Secondary | Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Milliseconds | Baseline; Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10 |
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| Secondary | Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5 |
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| Secondary | Period 2: Change From Baseline in SBP and DBP | SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7 |
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| Secondary | Period 3: Change From Baseline in SBP and DBP | SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
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| Secondary | Period 1: Change From Baseline in Pulse Rate | Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5 |
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| Secondary | Period 2: Change From Baseline in Pulse Rate | Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7 |
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| Secondary | Period 3: Change From Baseline in Pulse Rate | Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
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| Secondary | Period 1: Change From Baseline in Respiratory Rate | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Breaths per minute | Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5 |
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| Secondary | Period 2: Change From Baseline in Respiratory Rate | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Breaths per minute | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7 |
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| Secondary | Period 3: Change From Baseline in Respiratory Rate | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Breaths per minute | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
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| Secondary | Period 1: Change From Baseline in Body Temperature | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5 |
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| Secondary | Period 2: Change From Baseline in Body Temperature | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7 |
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| Secondary | Period 3: Change From Baseline in Body Temperature | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Safety Population. | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
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| Secondary | Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. | Safety Population. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Day 9 |
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| Secondary | Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. | Safety Population. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Day 7 |
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| Secondary | Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. | Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | 10^9 cells per liter | Days 4, 7 and 10 |
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| Secondary | Period 1: Absolute Values for Hematology Parameter: Hemoglobin | Blood samples were collected to analyze the hematology parameter: hemoglobin. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Day 9 |
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| Secondary | Period 2: Absolute Values for Hematology Parameter: Hemoglobin | Blood samples were collected to analyze the hematology parameter: hemoglobin. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Day 7 |
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| Secondary | Period 3: Absolute Values for Hematology Parameter: Hemoglobin | Blood samples were collected to analyze the hematology parameter: hemoglobin. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Days 4, 7 and 10 |
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| Secondary | Period 1: Absolute Values for Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: hematocrit. | Safety Population. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Day 9 |
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| Secondary | Period 2: Absolute Values for Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: hematocrit. | Safety Population. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Day 7 |
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| Secondary | Period 3: Absolute Values for Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: hematocrit. | Safety Population. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Days 4, 7 and 10 |
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| Secondary | Period 1: Absolute Values for Hematology Parameter: Erythrocytes | Blood samples were collected to analyze the hematology parameter: erythrocytes. | Safety Population. | Posted | Mean | Standard Deviation | Trillion cells per liter | Day 9 |
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| Secondary | Period 2: Absolute Values for Hematology Parameter: Erythrocytes | Blood samples were collected to analyze the hematology parameter: erythrocytes. | Safety Population. | Posted | Mean | Standard Deviation | Trillion cells per liter | Day 7 |
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| Secondary | Period 3: Absolute Values for Hematology Parameter: Erythrocytes | Blood samples were collected to analyze the hematology parameter: erythrocytes. | Safety Population. | Posted | Mean | Standard Deviation | Trillion cells per liter | Days 4, 7 and 10 |
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| Secondary | Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. | Safety Population. | Posted | Mean | Standard Deviation | Femtoliter | Day 9 |
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| Secondary | Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. | Safety Population. | Posted | Mean | Standard Deviation | Femtoliter | Day 7 |
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| Secondary | Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. | Safety Population. | Posted | Mean | Standard Deviation | Femtoliter | Days 4, 7 and 10 |
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| Secondary | Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. | Safety Population. | Posted | Mean | Standard Deviation | Picograms | Day 9 |
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| Secondary | Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. | Safety Population. | Posted | Mean | Standard Deviation | Picograms | Day 7 |
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| Secondary | Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. | Safety Population. | Posted | Mean | Standard Deviation | Picograms | Days 4, 7 and 10 |
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| Secondary | Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. | Safety Population. | Posted | Mean | Standard Deviation | Millimoles per liter | Day 9 |
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| Secondary | Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. | Safety Population. | Posted | Mean | Standard Deviation | Millimoles per liter | Day 7 |
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| Secondary | Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen | Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. | Safety Population. | Posted | Mean | Standard Deviation | Millimoles per liter | Days 4, 7 and 10 |
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| Secondary | Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. | Safety Population. | Posted | Mean | Standard Deviation | International units per liter | Day 9 |
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| Secondary | Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. | Safety Population. | Posted | Mean | Standard Deviation | International units per liter | Day 7 |
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| Secondary | Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase | Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. | Safety Population. | Posted | Mean | Standard Deviation | International units per liter | Days 4, 7 and 10 |
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| Secondary | Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter | Day 9 |
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| Secondary | Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter | Day 7 |
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| Secondary | Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin | Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter | Days 4, 7 and 10 |
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| Secondary | Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Day 9 |
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| Secondary | Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Day 7 |
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| Secondary | Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein | Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter | Days 4, 7 and 10 |
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| Secondary | Period 1: Absolute Values for Chemistry Parameters: Amylase, Lipase | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. | Safety Population. | Posted | Mean | Standard Deviation | Units per liter | Day 9 |
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| Secondary | Period 2: Absolute Values for Chemistry Parameters: Amylase, Lipase | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. | Safety Population. | Posted | Mean | Standard Deviation | Units per liter | Day 7 |
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| Secondary | Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase | Blood samples were collected to analyze the chemistry parameters: amylase and lipase. | Safety Population. | Posted | Mean | Standard Deviation | Units per liter | Days 4, 7 and 10 |
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| Secondary | Period 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. | Safety Population. | Posted | Mean | Standard Deviation | Ratio | Day 9 |
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| Secondary | Period 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. | Safety Population. | Posted | Mean | Standard Deviation | Ratio | Day 7 |
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| Secondary | Period 3: 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. | Safety Population. | Posted | Mean | Standard Deviation | Ratio | Days 4, 7 and 10 |
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| Secondary | Period 1: Absolute Values for Urinalysis Parameter: Urobilinogen | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter | Day 9 |
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| Secondary | Period 2: Absolute Values for Urinalysis Parameter: Urobilinogen | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter | Day 7 |
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| Secondary | Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen | Urine samples were collected to analyze the urinalysis parameter: urobilinogen. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter | Days 4, 7 and 10 |
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| Secondary | Period 1: Absolute Values for Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Safety Population. | Posted | Mean | Standard Deviation | pH | Day 9 |
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| Secondary | Period 2: Absolute Values for Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Safety Population. | Posted | Mean | Standard Deviation | pH | Day 7 |
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| Secondary | Period 3: Absolute Values for Urinalysis Parameter: 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. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). | Safety Population. | Posted | Mean | Standard Deviation | pH | Days 4, 7 and 10 |
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| Secondary | Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. | Safety Population. | Posted | Mean | Standard Deviation | Milliseconds | Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours |
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| Secondary | Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. | Safety Population. | Posted | Mean | Standard Deviation | Milliseconds | Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours |
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| Secondary | Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB | Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. | Safety Population. | Posted | Mean | Standard Deviation | Milliseconds | Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10 |
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| Secondary | Period 1: Absolute Values for SBP and DBP | SBP and DBP were measured in the semi-recumbent position with a completely automated device. | Safety Population. | Posted | Mean | Standard Deviation | Millimeters of mercury | Days 2, 3, 4 and 5 |
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| Secondary | Period 2: Absolute Values for SBP and DBP | SBP and DBP were measured in the semi-recumbent position with a completely automated device. | Safety Population. | Posted | Mean | Standard Deviation | Millimeters of mercury | Days 2, 3, 4, 5, 6 and 7 |
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| Secondary | Period 3: Absolute Values for SBP and DBP | SBP and DBP were measured in the semi-recumbent position with a completely automated device. | Safety Population. | Posted | Mean | Standard Deviation | Millimeters of mercury | Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
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| Secondary | Period 1: Absolute Values for Pulse Rate | Pulse rate was measured in the semi-recumbent position with a completely automated device. | Safety Population. | Posted | Mean | Standard Deviation | Beats per minute | Days 2, 3, 4 and 5 |
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| Secondary | Period 2: Absolute Values for Pulse Rate | Pulse rate was measured in the semi-recumbent position with a completely automated device. | Safety Population. | Posted | Mean | Standard Deviation | Beats per minute | Days 2, 3, 4, 5, 6 and 7 |
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| Secondary | Period 3: Absolute Values for Pulse Rate | Pulse rate was measured in the semi-recumbent position with a completely automated device. | Safety Population. | Posted | Mean | Standard Deviation | Beats per minute | Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
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| Secondary | Period 1: Absolute Values for Respiratory Rate | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population. | Posted | Mean | Standard Deviation | Breaths per minute | Days 2, 3, 4 and 5 |
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| Secondary | Period 2: Absolute Values for Respiratory Rate | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Breaths per minute | Days 2, 3, 4, 5, 6 and 7 |
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| Secondary | Period 3: Absolute Values for Respiratory Rate | Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population. | Posted | Mean | Standard Deviation | Breaths per minute | Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
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| Secondary | Period 1: Absolute Values for Body Temperature | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population. | Posted | Mean | Standard Deviation | Degrees Celsius | Days 2, 3, 4 and 5 |
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| Secondary | Period 2: Absolute Values for Body Temperature | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population. | Posted | Mean | Standard Deviation | Degrees Celsius | Days 2, 3, 4, 5, 6 and 7 |
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| Secondary | Period 3: Absolute Values for Body Temperature | Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. | Safety Population. | Posted | Mean | Standard Deviation | Degrees Celsius | Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
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| Secondary | Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 for GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Median | Full Range | Hours | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Secondary | Period 3: Tmax of GSK3640254 for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Median | Full Range | Hours | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Secondary | Period 2: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 for GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Data could not be determined due to limited sampling points after final dosing (during elimination phase). An accurate determination of GSK3640254 half-life would require sampling up to 3 times half-life (3 * approximately 24 hours). However sampling in Period 2 was performed up to only 24 hours post-dose. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Secondary | Period 3: T1/2 of GSK3640254 for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Secondary | Period 1: Tmax of Dolutegravir for Dolutegravir Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Median | Full Range | Hours | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Secondary | Period 3: Tmax of Dolutegravir for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Median | Full Range | Hours | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Secondary | Period 1: T1/2 of Dolutegravir for Dolutegravir Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| Secondary | Period 3: T1/2 of Dolutegravir for Dolutegravir + GSK3640254 Arm | Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. | Pharmacokinetic Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose |
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| 0 |
| 16 |
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | GSK3640254 200 mg | In Period 2, participants received GSK3640254 200 mg, capsules, orally (treatment B) once daily on Days 1 through 7. | 0 | 16 | 0 | 16 | 3 | 16 |
| EG002 | Dolutegravir 50 mg + GSK3640254 200 mg | In Period 3, participants co-administered dolutegravir 50 mg, tablets, orally, once daily along with GSK3640254 200 mg, capsules, orally (treatment C), once daily on Days 1 through 7. Participants were followed up for 4 days after last dose of study treatment. | 0 | 16 | 0 | 16 | 2 | 16 |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Keratosis pilaris | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Medical device site dermatitis | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Ear pruritus | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 21.1 | 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 |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Monocytes |
|
| Neutrophils |
|
| Platelet count |
|
| Title | Measurements |
|---|---|
|
| Monocytes |
|
| Neutrophils |
|
| Platelet count |
|
|
| Day 10: Basophils, n=16 |
|
|
| Day 4: Eosinophils, n=16 |
|
|
| Day 7: Eosinophils, n=16 |
|
|
| Day 10: Eosinophils, n=16 |
|
|
| Day 4: Lymphocytes, n=16 |
|
|
| Day 7: Lymphocytes, n=16 |
|
|
| Day 10: Lymphocytes, n=16 |
|
|
| Day 4: Monocytes, n=16 |
|
|
| Day 7: Monocytes, n=16 |
|
|
| Day 10: Monocytes, n=16 |
|
|
| Day 4: Neutrophils, n=16 |
|
|
| Day 7: Neutrophils, n=16 |
|
|
| Day 10: Neutrophils, n=16 |
|
|
| Day 4: Platelet count, n=16 |
|
|
| Day 7: Platelet count, n=15 |
|
|
| Day 10: Platelet count, n=16 |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Anion gap |
|
| Calcium |
|
| Carbon dioxide |
|
| Chloride |
|
| Phosphate |
|
| Potassium |
|
| Sodium |
|
| Blood urea nitrogen |
|
| Title | Measurements |
|---|---|
|
| Anion gap |
|
| Calcium |
|
| Carbon dioxide |
|
| Chloride |
|
| Phosphate |
|
| Potassium |
|
| Sodium |
|
| Blood urea nitrogen |
|
| Title | Measurements |
|---|---|
|
| Day 4: Cholesterol |
|
| Day 7: Cholesterol |
|
| Day 10: Cholesterol |
|
| Day 4: Triglycerides |
|
| Day 7: Triglycerides |
|
| Day 10: Triglycerides |
|
| Day 4: Anion gap |
|
| Day 7: Anion gap |
|
| Day 10: Anion gap |
|
| Day 4: Calcium |
|
| Day 7: Calcium |
|
| Day 10: Calcium: |
|
| Day 4: Carbon dioxide |
|
| Day 7: Carbon dioxide |
|
| Day 10: Carbon dioxide |
|
| Day 4: Chloride |
|
| Day 7: Chloride |
|
| Day 10: Chloride |
|
| Day 4: Phosphate |
|
| Day 7: Phosphate |
|
| Day 10: Phosphate |
|
| Day 4: Potassium |
|
| Day 7: Potassium |
|
| Day 10: Potassium |
|
| Day 4: Sodium |
|
| Day 7: Sodium |
|
| Day 10: Sodium |
|
| Day 4: Blood urea nitrogen |
|
| Day 7: Blood urea nitrogen |
|
| Day 10: Blood urea nitrogen |
|
| Title | Measurements |
|---|---|
|
| ALP |
|
| AST |
|
| Gamma-glutamyl transferase |
|
| Title | Measurements |
|---|---|
|
| ALP |
|
| AST |
|
| Gamma-glutamyl transferase |
|
| Title | Measurements |
|---|---|
|
| Day 4: Lactate dehydrogenase |
|
| Day 7: Lactate dehydrogenase |
|
| Day 10: Lactate dehydrogenase |
|
| Day 4: ALT |
|
| Day 7: ALT |
|
| Day 10: ALT |
|
| Day 4: ALP |
|
| Day 7: ALP |
|
| Day 10: ALP |
|
| Day 4: AST |
|
| Day 7: AST |
|
| Day 10: AST |
|
| Day 4: Gamma-glutamyl transferase |
|
| Day 7: Gamma-glutamyl transferase |
|
| Day 10: Gamma-glutamyl transferase |
|
| Title | Measurements |
|---|---|
|
| Direct bilirubin |
|
| Title | Measurements |
|---|---|
|
| Direct bilirubin |
|
| Title | Measurements |
|---|---|
|
| Day 4: Creatinine |
|
| Day 7: Creatinine |
|
| Day 10: Creatinine |
|
| Day 4: Bilirubin |
|
| Day 7: Bilirubin |
|
| Day 10: Bilirubin |
|
| Day 4: Direct bilirubin |
|
| Day 7: Direct bilirubin |
|
| Day 10: Direct bilirubin |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Day 4: Globulin |
|
| Day 7: Globulin |
|
| Day 10: Globulin |
|
| Day 4: Protein |
|
| Day 7: Protein |
|
| Day 10: Protein |
|
| Title | Measurements |
|---|---|
|
| Day 4: Lipase |
|
| Day 7: Lipase |
|
| Day 10: Lipase |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Ketones: Trace |
|
| Leukocyte Esterase: Negative |
|
| Nitrite: Negative |
|
| Occult Blood: Negative |
|
| Occult Blood: 2+ |
|
| Protein: Negative |
|
| Title | Measurements |
|---|---|
|
| Ketones: 1+ |
|
| Leukocyte Esterase: Negative |
|
| Leukocyte Esterase: 1+ |
|
| Nitrite: Negative |
|
| Occult Blood: Negative |
|
| Protein: Negative |
|
| Title | Measurements |
|---|---|
|
| Glucose: Day 4, Negative |
|
| Glucose: Day 7, Negative |
|
| Glucose: Day 10, Negative |
|
| Ketones: Day 4, Negative |
|
| Ketones: Day 7, Negative |
|
| Ketones: Day 10, Negative |
|
| Leukocyte Esterase: Day 4, Negative |
|
| Leukocyte Esterase: Day 7, Negative |
|
| Leukocyte Esterase: Day 10, Negative |
|
| Nitrite: Day 4, Negative |
|
| Nitrite: Day 7, Negative |
|
| Nitrite: Day 10, Negative |
|
| Occult Blood: Day 4, Negative |
|
| Occult Blood: Day 7, Negative |
|
| Occult Blood: Day 10, Negative |
|
| Protein: Day 4, Negative |
|
| Protein: Day 7, Negative |
|
| Protein: Day 10, Negative |
|
| Title | Measurements |
|---|---|
|
| PR Interval: Day 5, 2 hours |
|
| PR Interval: Day 5, 4 hours |
|
| QRS Duration: Day 1, 2 hours |
|
| QRS Duration: Day 1, 4 hours |
|
| QRS Duration: Day 5, Pre-dose |
|
| QRS Duration: Day 5, 2 hours |
|
| QRS Duration: Day 5, 4 hours |
|
| QT Interval: Day 1, 2 hours |
|
| QT Interval: Day 1, 4 hours |
|
| QT Interval: Day 5, Pre-dose |
|
| QT Interval: Day 5, 2 hours |
|
| QT Interval: Day 5, 4 hours |
|
| QTcF Interval: Day 1, 2 hours |
|
| QTcF Interval: Day 1, 4 hours |
|
| QTcF Interval: Day 5, Pre-dose |
|
| QTcF Interval: Day 5, 2 hours |
|
| QTcF Interval: Day 5, 4 hours |
|
| QTcB Interval: Day 1, 2 hours |
|
| QTcB Interval: Day 1, 4 hours |
|
| QTcB Interval: Day 5, Pre-dose |
|
| QTcB Interval: Day 5, 2 hours |
|
| QTcB Interval: Day 5, 4 hours |
|
| Title | Measurements |
|---|---|
|
| PR Interval: Day 5, 2 hours |
|
| PR Interval: Day 5, 4 hours |
|
| QRS Duration: Day 1, 2 hours |
|
| QRS Duration: Day 1, 4 hours |
|
| QRS Duration: Day 5, Pre-dose |
|
| QRS Duration: Day 5, 2 hours |
|
| QRS Duration: Day 5, 4 hours |
|
| QT Interval: Day 1, 2 hours |
|
| QT Interval: Day 1, 4 hours |
|
| QT Interval: Day 5, Pre-dose |
|
| QT Interval: Day 5, 2 hours |
|
| QT Interval: Day 5, 4 hours |
|
| QTcF Interval: Day 1, 2 hours |
|
| QTcF Interval: Day 1, 4 hours |
|
| QTcF Interval: Day 5, Pre-dose |
|
| QTcF Interval: Day 5, 2 hours |
|
| QTcF Interval: Day 5, 4 hours |
|
| QTcB Interval: Day 1, 2 hours |
|
| QTcB Interval: Day 1, 4 hours |
|
| QTcB Interval: Day 5, Pre-dose |
|
| QTcB Interval: Day 5, 2 hours |
|
| QTcB Interval: Day 5, 4 hours |
|
| Title | Measurements |
|---|---|
|
| PR Interval: Day 4, 2 hours |
|
| PR Interval: Day 4, 4 hours |
|
| PR Interval: Day 5, Pre-dose |
|
| PR Interval: Day 5, 2 hours |
|
| PR Interval: Day 5, 4 hours |
|
| PR Interval: Day 7, Pre-dose |
|
| PR Interval: Day 7, 2 hours |
|
| PR Interval: Day 7, 4 hours |
|
| PR Interval: Day 10 |
|
| QRS Duration: Day 1, 2 hours |
|
| QRS Duration: Day 1, 4 hours |
|
| QRS Duration: Day 4, Pre-dose |
|
| QRS Duration: Day 4, 2 hours |
|
| QRS Duration: Day 4, 4 hours |
|
| QRS Duration: Day 5, Pre-dose |
|
| QRS Duration: Day 5, 2 hours |
|
| QRS Duration: Day 5, 4 hours |
|
| QRS Duration: Day 7, Pre-dose |
|
| QRS Duration: Day 7, 2 hours |
|
| QRS Duration: Day 7, 4 hours |
|
| QRS Duration: Day 10 |
|
| QT Interval: Day 1, 2 hours |
|
| QT Interval: Day 1, 4 hours |
|
| QT Interval: Day 4, Pre-dose |
|
| QT Interval: Day 4, 2 hours |
|
| QT Interval: Day 4, 4 hours |
|
| QT Interval: Day 5, Pre-dose |
|
| QT Interval: Day 5, 2 hours |
|
| QT Interval: Day 5, 4 hours |
|
| QT Interval: Day 7, Pre-dose |
|
| QT Interval: Day 7, 2 hours |
|
| QT Interval: Day 7, 4 hours |
|
| QT Interval: Day 10 |
|
| QTcF Interval: Day 1, 2 hours |
|
| QTcF Interval: Day 1, 4 hours |
|
| QTcF Interval: Day 4, Pre-dose |
|
| QTcF Interval: Day 4, 2 hours |
|
| QTcF Interval: Day 4, 4 hours |
|
| QTcF Interval: Day 5, Pre-dose |
|
| QTcF Interval: Day 5, 2 hours |
|
| QTcF Interval: Day 5, 4 hours |
|
| QTcF Interval: Day 7, Pre-dose |
|
| QTcF Interval: Day 7, 2 hours |
|
| QTcF Interval: Day 7, 4 hours |
|
| QTcF Interval: Day 10 |
|
| QTcB Interval: Day 1, 2 hours |
|
| QTcB Interval: Day 1, 4 hours |
|
| QTcB Interval: Day 4, Pre-dose |
|
| QTcB Interval: Day 4, 2 hours |
|
| QTcB Interval: Day 4, 4 hours |
|
| QTcB Interval: Day 5, Pre-dose |
|
| QTcB Interval: Day 5, 2 hours |
|
| QTcB Interval: Day 5, 4 hours |
|
| QTcB Interval: Day 7, Pre-dose |
|
| QTcB Interval: Day 7, 2 hours |
|
| QTcB Interval: Day 7, 4 hours |
|
| QTcB Interval: Day 10 |
|
| Title | Measurements |
|---|---|
|
| SBP: Day 5 |
|
| DBP: Day 2 |
|
| DBP: Day 3 |
|
| DBP: Day 4 |
|
| DBP: Day 5 |
|
| Title | Measurements |
|---|---|
|
| SBP: Day 5 |
|
| SBP: Day 6 |
|
| SBP: Day 7 |
|
| DBP: Day 2 |
|
| DBP: Day 3 |
|
| DBP: Day 4 |
|
| DBP: Day 5 |
|
| DBP: Day 6 |
|
| DBP: Day 7 |
|
| Title | Measurements |
|---|---|
|
| SBP: Day 5 |
|
| SBP: Day 6 |
|
| SBP: Day 7 |
|
| SBP: Day 8 |
|
| SBP: Day 9 |
|
| SBP: Day 10 |
|
| SBP: Day 11 |
|
| DBP: Day 2 |
|
| DBP: Day 3 |
|
| DBP: Day 4 |
|
| DBP: Day 5 |
|
| DBP: Day 6 |
|
| DBP: Day 7 |
|
| DBP: Day 8 |
|
| DBP: Day 9 |
|
| DBP: Day 10 |
|
| DBP: Day 11 |
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Day 8 |
|
| Day 9 |
|
| Day 10 |
|
| Day 11 |
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
|
| Day 4, n=16 |
|
|
| Day 5, n=15 |
|
|
| Day 6, n=16 |
|
|
| Day 7, n=16 |
|
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Day 8 |
|
| Day 9 |
|
| Day 10 |
|
| Day 11 |
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Day 8 |
|
| Day 9 |
|
| Day 10 |
|
| Day 11 |
|
| Title | Measurements |
|---|---|
|
| Monocytes |
|
| Neutrophils |
|
| Platelet count |
|
| Title | Measurements |
|---|---|
|
| Monocytes |
|
| Neutrophils |
|
| Platelet count |
|
|
| Day 10: Basophils, n=16 |
|
|
| Day 4: Eosinophils, n=16 |
|
|
| Day 7: Eosinophils, n=16 |
|
|
| Day 10: Eosinophils, n=16 |
|
|
| Day 4: Lymphocytes, n=16 |
|
|
| Day 7: Lymphocytes, n=16 |
|
|
| Day 10: Lymphocytes, n=16 |
|
|
| Day 4: Monocytes, n=16 |
|
|
| Day 7: Monocytes, n=16 |
|
|
| Day 10: Monocytes, n=16 |
|
|
| Day 4: Neutrophils, n=16 |
|
|
| Day 7: Neutrophils, n=16 |
|
|
| Day 10: Neutrophils, n=16 |
|
|
| Day 4: Platelet count, n=16 |
|
|
| Day 7: Platelet count, n=15 |
|
|
| Day 10: Platelet count, n=16 |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Anion gap |
|
| Calcium |
|
| Carbon dioxide |
|
| Chloride |
|
| Phosphate |
|
| Potassium |
|
| Sodium |
|
| Blood urea nitrogen |
|
| Title | Measurements |
|---|---|
|
| Anion gap |
|
| Calcium |
|
| Carbon dioxide |
|
| Chloride |
|
| Phosphate |
|
| Potassium |
|
| Sodium |
|
| Blood urea nitrogen |
|
| Title | Measurements |
|---|---|
|
| Day 4: Cholesterol |
|
| Day 7: Cholesterol |
|
| Day 10: Cholesterol |
|
| Day 4: Triglycerides |
|
| Day 7: Triglycerides |
|
| Day 10: Triglycerides |
|
| Day 4: Anion gap |
|
| Day 7: Anion gap |
|
| Day 10: Anion gap |
|
| Day 4: Calcium |
|
| Day 7: Calcium |
|
| Day 10: Calcium |
|
| Day 4: Carbon dioxide |
|
| Day 7: Carbon dioxide |
|
| Day 10: Carbon dioxide |
|
| Day 4: Chloride |
|
| Day 7: Chloride |
|
| Day 10: Chloride |
|
| Day 4: Phosphate |
|
| Day 7: Phosphate |
|
| Day 10: Phosphate |
|
| Day 4: Potassium |
|
| Day 7: Potassium |
|
| Day 10: Potassium |
|
| Day 4: Sodium |
|
| Day 7: Sodium |
|
| Day 10: Sodium |
|
| Day 4: Blood urea nitrogen |
|
| Day 7: Blood urea nitrogen |
|
| Day 10: Blood urea nitrogen |
|
| Title | Measurements |
|---|---|
|
| ALP |
|
| AST |
|
| Gamma-glutamyl transferase |
|
| Title | Measurements |
|---|---|
|
| ALP |
|
| AST |
|
| Gamma-glutamyl transferase |
|
| Title | Measurements |
|---|---|
|
| Day 4: Lactate dehydrogenase |
|
| Day 7: Lactate dehydrogenase |
|
| Day 10: Lactate dehydrogenase |
|
| Day 4: ALT |
|
| Day 7: ALT |
|
| Day 10: ALT |
|
| Day 4: ALP |
|
| Day 7: ALP |
|
| Day 10: ALP |
|
| Day 4: AST |
|
| Day 7: AST |
|
| Day 10: AST |
|
| Day 4: Gamma-glutamyl transferase |
|
| Day 7: Gamma-glutamyl transferase |
|
| Day 10: Gamma-glutamyl transferase |
|
| Title | Measurements |
|---|---|
|
| Direct bilirubin |
|
| Title | Measurements |
|---|
|
| Direct bilirubin |
|
| Title | Measurements |
|---|---|
|
| Day 4: Creatinine |
|
| Day 7: Creatinine |
|
| Day 10: Creatinine |
|
| Day 4: Bilirubin |
|
| Day 7: Bilirubin |
|
| Day 10: Bilirubin |
|
| Day 4: Direct bilirubin |
|
| Day 7: Direct bilirubin |
|
| Day 10: Direct bilirubin |
|
| Title | Measurements |
|---|---|
|
| Title |
|---|
| Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Day 4: Globulin |
|
| Day 7: Globulin |
|
| Day 10: Globulin |
|
| Day 4: Protein |
|
| Day 7: Protein |
|
| Day 10: Protein |
|
| Title | Measurements |
|---|---|
|
| Day 4: Lipase |
|
| Day 7: Lipase |
|
| Day 10: Lipase |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| PR Interval: Day 5, 2 hours |
|
| PR Interval: Day 5, 4 hours |
|
| QRS Duration: Day 1, 2 hours |
|
| QRS Duration: Day 1, 4 hours |
|
| QRS Duration: Day 5, Pre-dose |
|
| QRS Duration: Day 5, 2 hours |
|
| QRS Duration: Day 5, 4 hours |
|
| QT Interval: Day 1, 2 hours |
|
| QT Interval: Day 1, 4 hours |
|
| QT Interval: Day 5, Pre-dose |
|
| QT Interval: Day 5, 2 hours |
|
| QT Interval: Day 5, 4 hours |
|
| QTcF Interval: Day 1, 2 hours |
|
| QTcF Interval: Day 1, 4 hours |
|
| QTcF Interval: Day 5, Pre-dose |
|
| QTcF Interval: Day 5, 2 hours |
|
| QTcF Interval: Day 5, 4 hours |
|
| QTcB Interval: Day 1, 2 hours |
|
| QTcB Interval: Day 1, 4 hours |
|
| QTcB Interval: Day 5, Pre-dose |
|
| QTcB Interval: Day 5, 2 hours |
|
| QTcB Interval: Day 5, 4 hours |
|
| Title | Measurements |
|---|---|
|
| PR Interval: Day 5, 2 hours |
|
| PR Interval: Day 5, 4 hours |
|
| QRS Duration: Day 1, 2 hours |
|
| QRS Duration: Day 1, 4 hours |
|
| QRS Duration: Day 5, Pre-dose |
|
| QRS Duration: Day 5, 2 hours |
|
| QRS Duration: Day 5, 4 hours |
|
| QT Interval: Day 1, 2 hours |
|
| QT Interval: Day 1, 4 hours |
|
| QT Interval: Day 5, Pre-dose |
|
| QT Interval: Day 5, 2 hours |
|
| QT Interval: Day 5, 4 hours |
|
| QTcF Interval: Day 1, 2 hours |
|
| QTcF Interval: Day 1, 4 hours |
|
| QTcF Interval: Day 5, Pre-dose |
|
| QTcF Interval: Day 5, 2 hours |
|
| QTcF Interval: Day 5, 4 hours |
|
| QTcB Interval: Day 1, 2 hours |
|
| QTcB Interval: Day 1, 4 hours |
|
| QTcB Interval: Day 5, Pre-dose |
|
| QTcB Interval: Day 5, 2 hours |
|
| QTcB Interval: Day 5, 4 hours |
|
| Title | Measurements |
|---|---|
|
| PR Interval: Day 4, 2 hours |
|
| PR Interval: Day 4, 4 hours |
|
| PR Interval: Day 5, Pre-dose |
|
| PR Interval: Day 5, 2 hours |
|
| PR Interval: Day 5, 4 hours |
|
| PR Interval: Day 7, Pre-dose |
|
| PR Interval: Day 7, 2 hours |
|
| PR Interval: Day 7, 4 hours |
|
| PR Interval: Day 10 |
|
| QRS Duration: Day 1, 2 hours |
|
| QRS Duration: Day 1, 4 hours |
|
| QRS Duration: Day 4, Pre-dose |
|
| QRS Duration: Day 4, 2 hours |
|
| QRS Duration: Day 4, 4 hours |
|
| QRS Duration: Day 5, Pre-dose |
|
| QRS Duration: Day 5, 2 hours |
|
| QRS Duration: Day 5, 4 hours |
|
| QRS Duration: Day 7, Pre-dose |
|
| QRS Duration: Day 7, 2 hours |
|
| QRS Duration: Day 7, 4 hours |
|
| QRS Duration: Day 10 |
|
| QT Interval: Day 1, 2 hours |
|
| QT Interval: Day 1, 4 hours |
|
| QT Interval: Day 4, Pre-dose |
|
| QT Interval: Day 4, 2 hours |
|
| QT Interval: Day 4, 4 hours |
|
| QT Interval: Day 5, Pre-dose |
|
| QT Interval: Day 5, 2 hours |
|
| QT Interval: Day 5, 4 hours |
|
| QT Interval: Day 7, Pre-dose |
|
| QT Interval: Day 7, 2 hours |
|
| QT Interval: Day 7, 4 hours |
|
| QT Interval: Day 10 |
|
| QTcF Interval: Day 1, 2 hours |
|
| QTcF Interval: Day 1, 4 hours |
|
| QTcF Interval: Day 4, Pre-dose |
|
| QTcF Interval: Day 4, 2 hours |
|
| QTcF Interval: Day 4, 4 hours |
|
| QTcF Interval: Day 5, Pre-dose |
|
| QTcF Interval: Day 5, 2 hours |
|
| QTcF Interval: Day 5, 4 hours |
|
| QTcF Interval: Day 7, Pre-dose |
|
| QTcF Interval: Day 7, 2 hours |
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| QTcF Interval: Day 7, 4 hours |
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| QTcF Interval: Day 10 |
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| QTcB Interval: Day 1, 2 hours |
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| QTcB Interval: Day 1, 4 hours |
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| QTcB Interval: Day 4, Pre-dose |
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| QTcB Interval: Day 4, 2 hours |
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| QTcB Interval: Day 4, 4 hours |
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| QTcB Interval: Day 5, Pre-dose |
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| QTcB Interval: Day 5, 2 hours |
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| QTcB Interval: Day 5, 4 hours |
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| QTcB Interval: Day 7, Pre-dose |
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| QTcB Interval: Day 7, 2 hours |
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| QTcB Interval: Day 7, 4 hours |
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| QTcB Interval: Day 10 |
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| Title | Measurements |
|---|---|
|
| SBP: Day 5 |
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| DBP: Day 2 |
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| DBP: Day 3 |
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| DBP: Day 4 |
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| DBP: Day 5 |
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| Title |
|---|
| Measurements |
|---|
|
| SBP: Day 5 |
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| SBP: Day 6 |
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| SBP: Day 7 |
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| DBP: Day 2 |
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| DBP: Day 3 |
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| DBP: Day 4 |
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| DBP: Day 5 |
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| DBP: Day 6 |
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| DBP: Day 7 |
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| Title | Measurements |
|---|---|
|
| SBP: Day 5 |
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| SBP: Day 6 |
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| SBP: Day 7 |
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| SBP: Day 8 |
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| SBP: Day 9 |
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| SBP: Day 10 |
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| SBP: Day 11 |
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| DBP: Day 2 |
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| DBP: Day 3 |
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| DBP: Day 4 |
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| DBP: Day 5 |
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| DBP: Day 6 |
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| DBP: Day 7 |
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| DBP: Day 8 |
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| DBP: Day 9 |
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| DBP: Day 10 |
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| DBP: Day 11 |
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| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Title |
|---|
| Measurements |
|---|
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
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| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Day 6 |
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| Day 7 |
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| Day 8 |
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| Day 9 |
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| Day 10 |
|
| Day 11 |
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
|
| Day 4, n=16 |
|
|
| Day 5, n=15 |
|
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| Day 6, n=16 |
|
|
| Day 7, n=16 |
|
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Day 6 |
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| Day 7 |
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| Day 8 |
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| Day 9 |
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| Day 10 |
|
| Day 11 |
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Title | Measurements |
|---|
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Day 8 |
|
| Day 9 |
|
| Day 10 |
|
| Day 11 |
|