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Human immunodeficiency virus (HIV) infection frequently involves combination drug therapy for its treatment; hence, it is important to understand their interactions and resulting changes in exposure which are associated with medications. This is a Phase-1, open-label, fixed-sequence 2-period, one-way drug interaction study to assess the pharmacokinetic (PK), safety, and tolerability of GSK3640254 and Tenofovir alafenamide/emtricitabine (TAF/FTC) when administered alone and in combination in healthy subjects. The study will consist of a screening period of 28 days before the first dose of study intervention followed by 2 sequential treatment periods. Subjects will be administered TAF/FTC 25/200 milligram (mg) once daily (QD) on Days 1 to 14 of Period 1 followed by co-administration of TAF/FTC 25/200 mg QD with GSK3640254 200 mg QD on Days 1 to 7 of Period 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAF/FTC followed by TAF/FTC + GSK3640254 | Experimental | Subjects will receive TAF/FTC 25/200 mg QD on Days 1 through 14 in Treatment Period 1. Subjects will be co-administered TAF/FTC 25/200 mg QD with GSK3640254 200 mg QD on Days 1 through 7 in Treatment Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir alafenamide/emtricitabine | Drug | TAF/FTC will be available as 25/200 milligrams (mg) tablet. Subjects will be administered TAF/FTC 25/200 mg QD via the oral route. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
| Period 2: AUC (0-tau) of TAF | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Period 1: Maximum Observed Concentration (Cmax) of TAF | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
| Period 2: Cmax of TAF | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Period 1: AUC (0-tau) of FTC | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) | An adverse events (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: 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; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before |
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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 |
|---|---|---|---|
| 33753329 | Derived | Pene Dumitrescu T, Joshi SR, Xu J, Zhan J, Johnson M, Butcher L, Zimmerman E, Webster L, Davidson AM, Lataillade M, Min S. A Phase I Evaluation of the Pharmacokinetics and Tolerability of the HIV-1 Maturation Inhibitor GSK3640254 and Tenofovir Alafenamide/Emtricitabine in Healthy Participants. Antimicrob Agents Chemother. 2021 May 18;65(6):e02173-20. doi: 10.1128/AAC.02173-20. Print 2021 May 18. |
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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 16 participants were enrolled in the study.
This was an open-label, single-sequence one-way interaction drug interaction study to investigate the effect of GSK3640254 on the pharmacokinetics (PK) of tenofovir alafenamide (TAF) and emtricitabine (FTC).
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| ID | Title | Description |
|---|---|---|
| FG000 | TAF/FTC Followed by TAF/FTC+GSK3640254 | Participants in Period 1 received 25 milligram (mg) of TAF and 200 mg of FTC once daily (QD) on Days 1 through 14. In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (Up to Day 14) |
| |||||||||||||
| Treatment Period 2 (Up to Day 7) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAF/FTC Followed by TAF/FTC+GSK3640254 | Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. In Period 2 participant's co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Interval at Steady State (AUC [0-tau]) of TAF | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
|
Non-serious AEs and SAEs were collected from the start of the study treatment up to Day 24
Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one 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 | TAF/FTC | Participants in Period 1 received 25 mg of TAF and 200 mg of FTC QD on Days 1 through 14. There was no washout period between two periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | ViiV Healthcare | 8664357343 | 1 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2019 | Mar 12, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 27, 2018 | Mar 17, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C000613801 | emtricitabine tenofovir alafenamide |
| C000723722 | GSK3640254 |
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This is a fixed-sequence 2-period, one-way drug interaction study
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| GSK3640254 | Drug | GSK3640254 will be available as 100 mg capsule. Subjects will be administered GSK3640254 200 mg capsule QD via the oral route. |
|
| Period 2: AUC (0-tau) of FTC | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Period 1:Cmax of FTC | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
| Period 2:Cmax of FTC | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
| Period 2: Ctau of FTC | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Period 1: AUC (0-tau) of Tenofovir (TFV) | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
| Period 2: AUC (0-tau) of TFV | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Period 1: Cmax of TFV | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
| Period 2: Cmax of TFV | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Period 1: Ctau of TFV | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
| Period 2: Ctau of TFV | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Up to Day 24 |
| Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, and 14 |
| Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Blood samples were collected at indicated timepoints for analysis for hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. | Baseline and at Days 7, and 14 |
| Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Hematology Parameter of Hematocrit | Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, 14 |
| Period 2: Change From Baseline in Hematology Parameter of Hematocrit | Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of the Hematology Parameter: Hematocrit | Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. | Baseline and at Days 7, 14 |
| Period 2: Absolute Values of the Hematology Parameter: Hematocrit | Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Hematology Parameter of Hemoglobin | Blood samples were collected at indicated timepoints for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, 14 |
| Period 2: Change From Baseline in Hematology Parameter of Hemoglobin | Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of the Hematology Parameter: Hemoglobin | Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. | Baseline and at Days 7, 14 |
| Period 2: Absolute Values of the Hematology Parameter: Hemoglobin | Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) | Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, 14 |
| Period 2: Change From Baseline in Hematology Parameter of MCH | Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of the Hematology Parameter: MCH | Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. | Baseline and at Days 7, 14 |
| Period 2: Absolute Values of the Hematology Parameter: MCH | Blood samples were collected at indicated time-points for analysis of hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) | Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, 14 |
| Period 2: Change From Baseline in Hematology Parameter of MCV | Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of the Hematology Parameter: MCV | Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. | Baseline and at Days 7, 14 |
| Period 2: Absolute Values of the Hematology Parameter: MCV | Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Hematology Parameter of Erythrocytes | Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, 14 |
| Period 2: Change From Baseline in Hematology Parameter of Erythrocytes | Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of the Hematology Parameter: Erythrocytes | Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. | Baseline and at Days 7, 14 |
| Period 2: Absolute Values of the Hematology Parameter: Erythrocytes | Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, 14 |
| Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. | Baseline and at Days 7, 14 |
| Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK) | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter like alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, 14 |
| Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. | Baseline and at Days 7, 14 |
| Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, 14 |
| Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. | Baseline and at Days 7, 14 |
| Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, 14 |
| Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. | Baseline and at Days 7, 14 |
| Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, 14 |
| Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. | Baseline and at Days 7, 14 |
| Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Specific Gravity of Urine | Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, 14 |
| Period 2: Change From Baseline in Specific Gravity of Urine | Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of Specific Gravity of Urine | Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. | Baseline and at Days 7, 14 |
| Period 2: Absolute Values of Specific Gravity of Urine | Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine | Urine samples were collected at indicated time points for the assessment of Urinary 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 Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, 14 |
| Period 2: Change From Baseline in pH of Urine | Urine samples were collected at indicated time points for the assessment of Urinary 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 Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of pH of Urine | Urine samples were collected at indicated time points for the assessment of Urinary 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 Day -1 for Period 1. | Baseline and at Days 7, 14 |
| Period 2: Absolute Values of pH of Urine | Urine samples were collected at indicated time points for the assessment of Urinary 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 Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Urine Urobilinogen | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 7, 14 |
| Period 2: Change From Baseline in Urine Urobilinogen | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 3, 7, 9 |
| Period 1: Absolute Values of Urine Urobilinogen | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. | Baseline and at Days 7, 14 |
| Period 2: Absolute Values of Urine Urobilinogen | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. | Baseline and at Days 3, 7, 9 |
| Period 1: Change From Baseline in Heart Rate | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Day 1, 2 and 4 hours post-dose |
| Period 2: Change From Baseline in Heart Rate | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose |
| Period 1: Absolute Values of Heart Rate | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Day 1, 2 and 4 hours post-dose |
| Period 2: Absolute Values of Heart Rate | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. | Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose |
| Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Day 1, 2 and 4 hours post-dose |
| Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose |
| Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. | Baseline and at Day 1, 2 and 4 hours post-dose |
| Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. | Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose |
| Period 1: Change From Baseline in Temperature | Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 2, 3, 4, 5 and 7 |
| Period 2: Change From Baseline in Temperature | Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 4, 7, 9, and 10 |
| Period 1: Absolute Values of Temperature | Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Baseline and at Days 2, 3, 4, 5 and 7 |
| Period 2: Absolute Values of Temperature | Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Baseline and at Days 4, 7, 9, and 10 |
| Period 1: Change From Baseline in Pulse Rate | Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 2, 3, 4, 5 and 7 |
| Period 2: Change From Baseline in Pulse Rate | Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 4, 7, 9, and 10 |
| Period 1: Absolute Values of Pulse Rate | Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Baseline and at Days 2, 3, 4, 5 and 7 |
| Period 2: Absolute Values of Pulse Rate | Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Baseline and at Days 4, 7, 9, and 10 |
| Period 1: Change From Baseline in Respiratory Rate | Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 2, 3, 4, 5 and 7 |
| Period 2: Change From Baseline in Respiratory Rate | Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 4, 7, 9, and 10 |
| Period 1: Absolute Values of Respiratory Rate | Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Baseline and at Days 2, 3, 4, 5 and 7 |
| Period 2: Absolute Values of Respiratory Rate | Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Baseline and at Days 4, 7, 9, and 10 |
| Period 1: Change From Baseline in Blood Pressure | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 2, 3, 4, 5 and 7 |
| Period 2: Change From Baseline in Blood Pressure | SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and at Days 4, 7, 9, and 10 |
| Period 1: Absolute Values of Blood Pressure | SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Baseline and at Days 2, 3, 4, 5 and 7 |
| Period 2: Absolute Values of Blood Pressure | SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Baseline and at Days 4, 7, 9, and 10 |
| Period 2: AUC (0-tau) of GSK3640254 | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Period 2: Cmax of GSK3640254 | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Period 2: Ctau of GSK3640254 | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 1 and 2 hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Period 1: Tmax of TAF | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
| Period 2: Tmax of TAF | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Period 1: Tmax of FTC | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
| Period 2: Tmax of FTC | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
| Period 1: Tmax of TFV | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
| Period 2: Tmax of TFV | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Primary | Period 2: AUC (0-tau) of TAF | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
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| Primary | Period 1: Maximum Observed Concentration (Cmax) of TAF | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
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| Primary | Period 2: Cmax of TAF | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
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| Primary | Period 1: AUC (0-tau) of FTC | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
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| Primary | Period 2: AUC (0-tau) of FTC | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
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| Primary | Period 1:Cmax of FTC | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
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| Primary | Period 2:Cmax of FTC | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
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| Primary | Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
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| Primary | Period 2: Ctau of FTC | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
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| Primary | Period 1: AUC (0-tau) of Tenofovir (TFV) | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
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| Primary | Period 2: AUC (0-tau) of TFV | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
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| Primary | Period 1: Cmax of TFV | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
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| Primary | Period 2: Cmax of TFV | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
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| Primary | Period 1: Ctau of TFV | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
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| Primary | Period 2: Ctau of TFV | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
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| Secondary | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) | An adverse events (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: 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; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before | Safety Population included all participants who received at least 1 dose of study medication. | Posted | Number | Participants | Up to Day 24 |
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| Secondary | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Giga cells per liter | Baseline and at Days 7, and 14 |
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| Secondary | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Blood samples were collected at indicated timepoints for analysis for hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Giga cells per liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | Giga cells per liter | Baseline and at Days 7, and 14 |
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| Secondary | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Giga cells per liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Hematology Parameter of Hematocrit | Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Change From Baseline in Hematology Parameter of Hematocrit | Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of the Hematology Parameter: Hematocrit | Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Absolute Values of the Hematology Parameter: Hematocrit | Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Hematology Parameter of Hemoglobin | Blood samples were collected at indicated timepoints for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Grams per liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Change From Baseline in Hematology Parameter of Hemoglobin | Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Grams per liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of the Hematology Parameter: Hemoglobin | Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | Grams per liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Absolute Values of the Hematology Parameter: Hemoglobin | Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Grams per liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) | Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Picograms | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Change From Baseline in Hematology Parameter of MCH | Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Picograms | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of the Hematology Parameter: MCH | Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | Picograms | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Absolute Values of the Hematology Parameter: MCH | Blood samples were collected at indicated time-points for analysis of hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Picograms | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) | Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Femtoliters | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Change From Baseline in Hematology Parameter of MCV | Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Femtoliters | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of the Hematology Parameter: MCV | Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | Femtoliters | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Absolute Values of the Hematology Parameter: MCV | Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Femtoliters | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Hematology Parameter of Erythrocytes | Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Trillion cells per liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Change From Baseline in Hematology Parameter of Erythrocytes | Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Trillion cells per liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of the Hematology Parameter: Erythrocytes | Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | Trillion cells per liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Absolute Values of the Hematology Parameter: Erythrocytes | Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Trillion cells per liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Millimoles per Liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Millimoles per Liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | Millimoles per Liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Millimoles per Liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK) | Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter like alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | International units per Liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | International units per Liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | International units per Liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | International units per Liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Units per Liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Units per Liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | Units per Liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Units per Liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Grams per Liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Grams per Liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | Grams per Liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Grams per Liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Specific Gravity of Urine | Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Ratio | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Change From Baseline in Specific Gravity of Urine | Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Ratio | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of Specific Gravity of Urine | Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | Ratio | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Absolute Values of Specific Gravity of Urine | Urine samples were collected at indicated time points for the assessment of 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. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Ratio | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine | Urine samples were collected at indicated time points for the assessment of Urinary 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 Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | pH | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Change From Baseline in pH of Urine | Urine samples were collected at indicated time points for the assessment of Urinary 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 Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | pH | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of pH of Urine | Urine samples were collected at indicated time points for the assessment of Urinary 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 Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | pH | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Absolute Values of pH of Urine | Urine samples were collected at indicated time points for the assessment of Urinary 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 Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | pH | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Urine Urobilinogen | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Change From Baseline in Urine Urobilinogen | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Absolute Values of Urine Urobilinogen | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. | Safety Population | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline and at Days 7, 14 |
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| Secondary | Period 2: Absolute Values of Urine Urobilinogen | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Micromoles per liter | Baseline and at Days 3, 7, 9 |
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| Secondary | Period 1: Change From Baseline in Heart Rate | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline and at Day 1, 2 and 4 hours post-dose |
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| Secondary | Period 2: Change From Baseline in Heart Rate | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Beats per minute | Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose |
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| Secondary | Period 1: Absolute Values of Heart Rate | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline and at Day 1, 2 and 4 hours post-dose |
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| Secondary | Period 2: Absolute Values of Heart Rate | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Beats per minute | Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose |
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| Secondary | Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Milliseconds | Baseline and at Day 1, 2 and 4 hours post-dose |
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| Secondary | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Milliseconds | Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose |
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| Secondary | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. | Safety Population | Posted | Mean | Standard Deviation | Milliseconds | Baseline and at Day 1, 2 and 4 hours post-dose |
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| Secondary | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Milliseconds | Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose |
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| Secondary | Period 1: Change From Baseline in Temperature | Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Degree Celsius | Baseline and at Days 2, 3, 4, 5 and 7 |
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| Secondary | Period 2: Change From Baseline in Temperature | Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points | Posted | Mean | Standard Deviation | Degree Celsius | Baseline and at Days 4, 7, 9, and 10 |
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| Secondary | Period 1: Absolute Values of Temperature | Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Safety Population | Posted | Mean | Standard Deviation | Degree Celsius | Baseline and at Days 2, 3, 4, 5 and 7 |
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| Secondary | Period 2: Absolute Values of Temperature | Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Degree Celsius | Baseline and at Days 4, 7, 9, and 10 |
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| Secondary | Period 1: Change From Baseline in Pulse Rate | Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline and at Days 2, 3, 4, 5 and 7 |
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| Secondary | Period 2: Change From Baseline in Pulse Rate | Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points | Posted | Mean | Standard Deviation | Beats per minute | Baseline and at Days 4, 7, 9, and 10 |
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| Secondary | Period 1: Absolute Values of Pulse Rate | Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Safety Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline and at Days 2, 3, 4, 5 and 7 |
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| Secondary | Period 2: Absolute Values of Pulse Rate | Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Beats per minute | Baseline and at Days 4, 7, 9, and 10 |
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| Secondary | Period 1: Change From Baseline in Respiratory Rate | Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Breaths per minute | Baseline and at Days 2, 3, 4, 5 and 7 |
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| Secondary | Period 2: Change From Baseline in Respiratory Rate | Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points | Posted | Mean | Standard Deviation | Breaths per minute | Baseline and at Days 4, 7, 9, and 10 |
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| Secondary | Period 1: Absolute Values of Respiratory Rate | Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Safety Population | Posted | Mean | Standard Deviation | Breaths per minute | Baseline and at Days 2, 3, 4, 5 and 7 |
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| Secondary | Period 2: Absolute Values of Respiratory Rate | Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Breaths per minute | Baseline and at Days 4, 7, 9, and 10 |
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| Secondary | Period 1: Change From Baseline in Blood Pressure | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline and at Days 2, 3, 4, 5 and 7 |
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| Secondary | Period 2: Change From Baseline in Blood Pressure | SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified time points | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline and at Days 4, 7, 9, and 10 |
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| Secondary | Period 1: Absolute Values of Blood Pressure | SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Safety Population | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline and at Days 2, 3, 4, 5 and 7 |
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| Secondary | Period 2: Absolute Values of Blood Pressure | SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline and at Days 4, 7, 9, and 10 |
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| Secondary | Period 2: AUC (0-tau) of GSK3640254 | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
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| Secondary | Period 2: Cmax of GSK3640254 | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
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| Secondary | Period 2: Ctau of GSK3640254 | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 1 and 2 hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
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| Secondary | Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Median | Full Range | Hours | Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
|
|
|
| Secondary | Period 1: Tmax of TAF | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Median | Full Range | Hours | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
|
|
|
| Secondary | Period 2: Tmax of TAF | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Median | Full Range | Hours | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
|
|
|
| Secondary | Period 1: Tmax of FTC | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Median | Full Range | Hours | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
|
|
|
| Secondary | Period 2: Tmax of FTC | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Median | Full Range | Hours | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
|
|
|
| Secondary | Period 1: Tmax of TFV | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Median | Full Range | Hours | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14 |
|
|
|
| Secondary | Period 2: Tmax of TFV | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. | PK Parameter Population | Posted | Median | Full Range | Hours | Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7 |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 9 |
| 16 |
| EG001 | TAF/FTC+GSK3640254 | In Period 2 participants co-administered 25 mg TAF and 200 mg FTC QD along with GSK3640254 200 mg QD on Days 1 through 7. There was no washout period between two periods. | 0 | 16 | 0 | 16 | 3 | 16 |
| Rash pustular | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Ingrown hair | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal 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 |
| D012897 | Slow Virus Diseases |
| Title | Measurements |
|---|---|
|
| Eosinophils, Period 1 Day 14 |
|
| Monocytes, Period 1 Day 7 |
|
| Monocytes, Period 1 Day 14 |
|
| Leukocytes, Period 1 Day 7 |
|
| Leukocytes, Period 1 Day 14 |
|
| Lymphocytes, Period 1 Day 7 |
|
| Lymphocytes, Period 1 Day 14 |
|
| Neutrophils, Period 1 Day 7 |
|
| Neutrophils, Period 1 Day 14 |
|
| Platelets, Period 1 Day 7 |
|
| Platelets, Period 1 Day 14 |
|
|
| Basophils, Period 2 Day 9, n= 15 |
|
|
| Eosinophils, Period 2 Day 3, n=15 |
|
|
| Eosinophils, Period 2 Day 7, n=15 |
|
|
| Eosinophils, Period 2 Day 9, n=16 |
|
|
| Monocytes, Period 2 Day 3, n= 16 |
|
|
| Monocytes, Period 2 Day 7, n= 15 |
|
|
| Monocytes, Period 2 Day 9, n= 15 |
|
|
| Leukocytes, Period 2 Day 3, n= 16 |
|
|
| Leukocytes, Period 2 Day 7, n= 15 |
|
|
| Leukocytes, Period 2 Day 9, n= 15 |
|
|
| Lymphocytes, Period 2 Day 3, n= 16 |
|
|
| Lymphocytes, Period 2 Day 7, n= 15 |
|
|
| Lymphocytes, Period 2 Day 9, n= 15 |
|
|
| Neutrophils, Period 2 Day 3, n= 16 |
|
|
| Neutrophils, Period 2 Day 7, n= 15 |
|
|
| Neutrophils, Period 2 Day 9, n= 15 |
|
|
| Platelets, Period 2 Day 3, n= 16 |
|
|
| Platelets, Period 2 Day 7, n= 15 |
|
|
| Platelets, Period 2 Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
| Eosinophils, Period 1 Baseline |
|
| Eosinophils, Period 1 Day 7 |
|
| Eosinophils, Period 1 Day 14 |
|
| Monocytes, Period 1 Baseline |
|
| Monocytes, Period 1 Day 7 |
|
| Monocytes, Period 1 Day 14 |
|
| Leukocytes, Period 1 Baseline |
|
| Leukocytes, Period 1 Day 7 |
|
| Leukocytes, Period 1 Day 14 |
|
| Lymphocytes, Period 1 Baseline |
|
| Lymphocytes, Period 1 Day 7 |
|
| Lymphocytes, Period 1 Day 14 |
|
| Neutrophils, Period 1 Baseline |
|
| Neutrophils, Period 1 Day 7 |
|
| Neutrophils, Period 1 Day 14 |
|
| Platelets, Period 1 Baseline |
|
| Platelets, Period 1 Day 7 |
|
| Platelets, Period 1 Day 14 |
|
|
| Basophils, Period 2 Day 7, n= 15 |
|
|
| Basophils, Period 2 Day 9, n= 15 |
|
|
| Eosinophils, Period 2 Baseline, n= 16 |
|
|
| Eosinophils, Period 2 Day 3, n= 15 |
|
|
| Eosinophils, Period 2 Day 7, n= 15 |
|
|
| Eosinophils, Period 2 Day 9, n= 16 |
|
|
| Monocytes, Period 2 Baseline, n= 16 |
|
|
| Monocytes, Period 2 Day 3, n= 16 |
|
|
| Monocytes, Period 2 Day 7, n= 15 |
|
|
| Monocytes, Period 2 Day 9, n= 15 |
|
|
| Leukocytes, Period 2 Baseline, n= 16 |
|
|
| Leukocytes, Period 2 Day 3, n= 16 |
|
|
| Leukocytes, Period 2 Day 7, n= 15 |
|
|
| Leukocytes, Period 2 Day 9, n= 15 |
|
|
| Lymphocytes, Period 2 Baseline, n= 16 |
|
|
| Lymphocytes, Period 2 Day 3, n= 16 |
|
|
| Lymphocytes, Period 2 Day 7, n= 15 |
|
|
| Lymphocytes, Period 2 Day 9, n= 15 |
|
|
| Neutrophils, Period 2 Baseline, n= 16 |
|
|
| Neutrophils, Period 2 Day 3, n= 16 |
|
|
| Neutrophils, Period 2 Day 7, n= 15 |
|
|
| Neutrophils, Period 2 Day 9, n= 15 |
|
|
| Platelets, Period 2 Baseline, n= 16 |
|
|
| Platelets, Period 2 Day 3, n= 16 |
|
|
| Platelets, Period 2 Day 7, n= 15 |
|
|
| Platelets, Period 2 Day 9, n= 15 |
|
|
|
| Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
|
| Day 7, n= 15 |
|
|
| Day 9, n= 15 |
|
|
|
| Day 9, n= 15 |
|
|
| Title | Measurements |
|---|
|
|
| Day 7, n= 15 |
|
|
| Day 9, n= 15 |
|
|
|
| Day 9, n= 15 |
|
|
| Title | Measurements |
|---|
|
|
| Day 7, n= 15 |
|
|
| Day 9, n= 15 |
|
|
|
| Day 9, n= 15 |
|
|
| Title | Measurements |
|---|
|
|
| Day 7, n= 15 |
|
|
| Day 9, n= 15 |
|
|
|
| Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
|
| Day 7, n= 15 |
|
|
| Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
| Cholesterol, Day 14 |
|
| Anion gap, Day 7 |
|
| Anion gap, Day 14 |
|
| Calcium, Day 7 |
|
| Calcium, Day 14 |
|
| CO2, Day 7 |
|
| CO2, Day 14 |
|
| Chloride, Day 7 |
|
| Chloride, Day 14 |
|
| Phosphate, Day 7 |
|
| Phosphate, Day 14 |
|
| Potassium, Day 7 |
|
| Potassium, Day 14 |
|
| Sodium, Day 7 |
|
| Sodium, Day 14 |
|
| Triglycerides, Day 7 |
|
| Triglycerides, Day 14 |
|
| BUN, Day 7 |
|
| BUN, Day 14 |
|
|
| Glucose, Day 9, n= 15 |
|
|
| Cholesterol, Day 3, n=15 |
|
|
| Cholesterol, Day 7, n= 15 |
|
|
| Cholesterol, Day 9, n= 16 |
|
|
| Anion gap, Day 3, n= 16 |
|
|
| Anion gap, Day 7, n= 15 |
|
|
| Anion gap, Day 9, n= 15 |
|
|
| Calcium, Day 3, n= 16 |
|
|
| Calcium, Day 7, n= 15 |
|
|
| Calcium, Day 9, n= 15 |
|
|
| CO2, Day 3, n= 16 |
|
|
| CO2, Day 7, n= 15 |
|
|
| CO2, Day 9, n= 15 |
|
|
| Chloride, Day 3, n= 16 |
|
|
| Chloride, Day 7, n= 15 |
|
|
| Chloride, Day 9, n= 15 |
|
|
| Phosphate, Day 3, n= 16 |
|
|
| Phosphate, Day 7, n= 15 |
|
|
| Phosphate, Day 9, n= 15 |
|
|
| Potassium, Day 3, n= 16 |
|
|
| Potassium, Day 7, n= 15 |
|
|
| Potassium, Day 9, n= 15 |
|
|
| Sodium, Day 3, n= 16 |
|
|
| Sodium, Day 7, n= 15 |
|
|
| Sodium, Day 9, n= 15 |
|
|
| Triglycerides, Day 3, n= 16 |
|
|
| Triglycerides, Day 7, n= 15 |
|
|
| Triglycerides, Day 9, n= 15 |
|
|
| BUN, Day 3, n= 16 |
|
|
| BUN, Day 7, n= 15 |
|
|
| BUN, Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
| Cholesterol, Baseline |
|
| Cholesterol, Day 7 |
|
| Cholesterol, Day 14 |
|
| Anion gap, Baseline |
|
| Anion gap, Day 7 |
|
| Anion gap, Day 14 |
|
| Calcium, Baseline |
|
| Calcium, Day 7 |
|
| Calcium, Day 14 |
|
| CO2, Baseline |
|
| CO2, Day 7 |
|
| CO2, Day 14 |
|
| Chloride, Baseline |
|
| Chloride, Day 7 |
|
| Chloride, Day 14 |
|
| Phosphate, Baseline |
|
| Phosphate, Day 7 |
|
| Phosphate, Day 14 |
|
| Potassium, Baseline |
|
| Potassium, Day 7 |
|
| Potassium, Day 14 |
|
| Sodium, Baseline |
|
| Sodium, Day 7 |
|
| Sodium, Day 14 |
|
| Triglycerides, Baseline |
|
| Triglycerides, Day 7 |
|
| Triglycerides, Day 14 |
|
| BUN, Baseline |
|
| BUN, Day 7 |
|
| BUN, Day 14 |
|
|
| Glucose, Day 7, n= 15 |
|
|
| Glucose, Day 9, n= 15 |
|
|
| Cholesterol, Baseline, n= 16 |
|
|
| Cholesterol, Day 3, n=15 |
|
|
| Cholesterol, Day 7, n= 15 |
|
|
| Cholesterol, Day 9, n= 16 |
|
|
| Anion gap, Baseline, n= 16 |
|
|
| Anion gap, Day 3, n= 16 |
|
|
| Anion gap, Day 7, n= 15 |
|
|
| Anion gap, Day 9, n= 15 |
|
|
| Calcium, Baseline, n= 16 |
|
|
| Calcium, Day 3, n= 16 |
|
|
| Calcium, Day 7, n= 15 |
|
|
| Calcium, Day 9, n= 15 |
|
|
| CO2, Baseline, n= 16 |
|
|
| CO2, Day 3, n= 16 |
|
|
| CO2, Day 7, n= 15 |
|
|
| CO2, Day 9, n= 15 |
|
|
| Chloride, Baseline, n= 16 |
|
|
| Chloride, Day 3, n= 16 |
|
|
| Chloride, Day 7, n= 15 |
|
|
| Chloride, Day 9, n= 15 |
|
|
| Phosphate, Baseline, n= 16 |
|
|
| Phosphate, Day 3, n= 16 |
|
|
| Phosphate, Day 7, n= 15 |
|
|
| Phosphate, Day 9, n= 15 |
|
|
| Potassium, Baseline, n= 16 |
|
|
| Potassium, Day 3, n= 16 |
|
|
| Potassium, Day 7, n= 15 |
|
|
| Potassium, Day 9, n= 15 |
|
|
| Sodium, Baseline, n= 16 |
|
|
| Sodium, Day 3, n= 16 |
|
|
| Sodium, Day 7, n= 15 |
|
|
| Sodium, Day 9, n=15 |
|
|
| Triglycerides, Baseline, n= 16 |
|
|
| Triglycerides, Day 3, n= 16 |
|
|
| Triglycerides, Day 7, n= 15 |
|
|
| Triglycerides, Day 9, n= 15 |
|
|
| BUN, Baseline, n= 16 |
|
|
| BUN, Day 3, n= 16 |
|
|
| BUN, Day 7, n= 15 |
|
|
| BUN Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
| AST, Day 14 |
|
| ALT, Day 7 |
|
| ALT, Day 14 |
|
| GGT Day 7 |
|
| GGT Day 14 |
|
| LDH, Day 7 |
|
| LDH, Day 14 |
|
| CK, Day 7 |
|
| CK, Day 14 |
|
|
| Alkaline phosphatase, Day 9, n= 15 |
|
|
| AST, Day 3, n= 16 |
|
|
| AST, Day 7, n= 15 |
|
|
| AST, Day 9, n= 15 |
|
|
| ALT, Day 3, n= 16 |
|
|
| ALT, Day 7, n= 15 |
|
|
| ALT, Day 9, n= 15 |
|
|
| GGT, Day 3, n= 16 |
|
|
| GGT, Day 7, n= 15 |
|
|
| GGT, Day 9, n= 15 |
|
|
| LDH, Day 3, n= 16 |
|
|
| LDH, Day 7, n= 15 |
|
|
| LDH, Day 9, n= 15 |
|
|
| CK, Day 3, n= 16 |
|
|
| CK, Day 7, n= 15 |
|
|
| CK, Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
| AST, Baseline |
|
| AST, Day 7 |
|
| AST, Day 14 |
|
| ALT, Baseline |
|
| ALT, Day 7 |
|
| ALT, Day 14 |
|
| GGT Baseline |
|
| GGT Day 7 |
|
| GGT Day 14 |
|
| LDH, Baseline |
|
| LDH, Day 7 |
|
| LDH, Day 9 |
|
| CK, Baseline |
|
| CK, Day 7 |
|
| CK, Day 14 |
|
|
| Alkaline phosphatase, Day 7, n= 15 |
|
|
| Alkaline phosphatase, Day 9, n= 15 |
|
|
| AST, Baseline, n= 16 |
|
|
| AST, Day 3, n= 16 |
|
|
| AST, Day 7, n= 15 |
|
|
| AST, Day 9, n= 15 |
|
|
| ALT, Baseline, n= 16 |
|
|
| ALT, Day 3, n= 16 |
|
|
| ALT, Day 7, n= 15 |
|
|
| ALT, Day 9, n= 15 |
|
|
| GGT, Baseline, n= 16 |
|
|
| GGT, Day 3, n= 16 |
|
|
| GGT, Day 7, n= 15 |
|
|
| GGT, Day 9, n= 15 |
|
|
| LDH, Baseline, n= 16 |
|
|
| LDH, Day 3, n= 16 |
|
|
| LDH, Day 7, n= 15 |
|
|
| LDH, Day 9, n= 15 |
|
|
| CK, Baseline, n= 16 |
|
|
| CK, Day 3, n= 16 |
|
|
| CK, Day 7, n= 15 |
|
|
| CK, Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
| Lipase, Day 14 |
|
|
| Amylase, Day 9, n= 15 |
|
|
| Lipase, Day 3, n= 16 |
|
|
| Lipase, Day 7, n= 15 |
|
|
| Lipase, Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
| Lipase, Baseline |
|
| Lipase, Day 7 |
|
| Lipase, Day 14 |
|
|
| Amylase, Day 7, n= 15 |
|
|
| Amylase, Day 9, n= 15 |
|
|
| Lipase, Baseline, n= 16 |
|
|
| Lipase, Day 3, n= 16 |
|
|
| Lipase, Day 7, n= 15 |
|
|
| Lipase, Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
| Total bilirubin, Day 14 |
|
| Direct bilirubin, Day 7 |
|
| Direct bilirubin, Day 14 |
|
|
| Creatinine, Day 9, n= 15 |
|
|
| Total bilirubin, Day 3, n= 16 |
|
|
| Total bilirubin, Day 7, n= 15 |
|
|
| Total bilirubin, Day 9, n= 15 |
|
|
| Direct bilirubin, Day 3, n= 16 |
|
|
| Direct bilirubin, Day 7, n= 15 |
|
|
| Direct bilirubin, Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
| Total bilirubin, Baseline |
|
| Total bilirubin, Day 7 |
|
| Total bilirubin, Day 14 |
|
| Direct bilirubin, Baseline |
|
| Direct bilirubin, Day 7 |
|
| Direct bilirubin, Day 14 |
|
|
| Creatinine, Day 7, n= 15 |
|
|
| Creatinine, Day 9, n= 15 |
|
|
| Total bilirubin, Baseline, n= 16 |
|
|
| Total bilirubin, Day 3, n= 16 |
|
|
| Total bilirubin, Day 7, n= 15 |
|
|
| Total bilirubin, Day 9, n= 15 |
|
|
| Direct bilirubin, Baseline, n= 16 |
|
|
| Direct bilirubin, Day 3, n= 16 |
|
|
| Direct bilirubin, Day 7, n= 15 |
|
|
| Direct bilirubin, Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
| Globulin, Day 14 |
|
| Albumin, Day 7 |
|
| Albumin, Day 14 |
|
|
| Total Protein, Day 9, n= 15 |
|
|
| Globulin, Day 3, n= 16 |
|
|
| Globulin, Day 7, n= 15 |
|
|
| Globulin, Day 9, n= 15 |
|
|
| Albumin, Day 3, n= 16 |
|
|
| Albumin, Day 7, n= 15 |
|
|
| Albumin, Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
| Globulin, Baseline |
|
| Globulin, Day 7 |
|
| Globulin, Day 14 |
|
| Albumin, Baseline |
|
| Albumin, Day 7 |
|
| Albumin, Day 14 |
|
|
| Total Protein, Day 7, n= 15 |
|
|
| Total Protein, Day 9, n= 15 |
|
|
| Globulin, Baseline, n= 16 |
|
|
| Globulin, Day 3, n= 16 |
|
|
| Globulin, Day 7, n= 15 |
|
|
| Globulin, Day 9, n= 15 |
|
|
| Albumin, Baseline, n= 16 |
|
|
| Albumin, Day 3, n= 16 |
|
|
| Albumin, Day 7, n= 15 |
|
|
| Albumin, Day 9, n= 15 |
|
|
|
| Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
|
| Day 7, n= 15 |
|
|
| Day 9, n= 15 |
|
|
|
| Day 9, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
|
| Day 7, n= 15 |
|
|
| Day 9, n= 15 |
|
|
|
| Day 9, n= 15 |
|
|
| Title | Measurements |
|---|
|
|
| Day 7, n= 15 |
|
|
| Day 9, n= 15 |
|
|
|
| Day 4, Pre-dose, n= 15 |
|
|
| Day 4, 2 hours post-dose, n= 15 |
|
|
| Day 4, 4 hours post-dose, n= 15 |
|
|
| Day 7, Pre-dose, n= 15 |
|
|
| Day 7, 2 hours post-dose, n= 15 |
|
|
| Day 7, 4 hours post-dose, n= 15 |
|
|
| Day 9 post-dose, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
|
| Day 1, 4 hours post-dose, n= 16 |
|
|
| Day 4, Pre-dose, n= 15 |
|
|
| Day 4, 2 hours post-dose, n= 15 |
|
|
| Day 4, 4 hours post-dose, n= 15 |
|
|
| Day 7, Pre-dose, n= 15 |
|
|
| Day 7, 2 hours post-dose, n= 15 |
|
|
| Day 7, 4 hours post-dose, n= 15 |
|
|
| Day 9 post-dose, n= 15 |
|
|
|
| QRS Duration, Day 1, 4 hours post-dose |
|
| QT Interval, Day 1, 2 hours post-dose |
|
| QT Interval, Day 1, 4 hours post-dose |
|
| QTcF Interval, Day 1, 2 hours post-dose |
|
| QTcF Interval, Day 1, 4 hours post-dose |
|
| QTcB Interval, Day 1, 2 hours post-dose |
|
| QTcB Interval, Day 1, 4 hours post-dose |
|
|
| PR Interval, Day 4, Pre-dose, n= 15 |
|
|
| PR Interval, Day 4, 2 hours post-dose, n= 15 |
|
|
| PR Interval, Day 4, 4 hours post-dose, n= 15 |
|
|
| PR Interval, Day 7, Pre-dose, n= 15 |
|
|
| PR Interval, Day 7, 2 hours post-dose, n= 15 |
|
|
| PR Interval, Day 7, 4 hours post-dose, n= 15 |
|
|
| PR Interval, Day 9 post-dose, n= 15 |
|
|
| QRS Duration, Day 1, 2 hours post-dose, n= 16 |
|
|
| QRS Duration, Day 1, 4 hours post-dose, n= 16 |
|
|
| QRS Duration, Day 4, Pre-dose, n= 15 |
|
|
| QRS Duration, Day 4, 2 hours post-dose, n= 15 |
|
|
| QRS Duration, Day 4, 4 hours post-dose, n= 15 |
|
|
| QRS Duration, Day 7, Pre-dose, n= 15 |
|
|
| QRS Duration, Day 7, 2 hours post-dose, n= 15 |
|
|
| QRS Duration, Day 7, 4 hours post-dose, n= 15 |
|
|
| QRS Duration, Day 9 post-dose, n= 15 |
|
|
| QT Interval, Day 1, 2 hours post-dose, n= 16 |
|
|
| QT Interval, Day 1, 4 hours post-dose, n= 16 |
|
|
| QT Interval, Day 4, Pre-dose, n= 15 |
|
|
| QT Interval, Day 4, 2 hours post-dose, n= 15 |
|
|
| QT Interval, Day 4, 4 hours post-dose, n= 15 |
|
|
| QT Interval, Day 7, Pre-dose, n= 15 |
|
|
| QT Interval, Day 7, 2 hours post-dose, n= 15 |
|
|
| QT Interval, Day 7, 4 hours post-dose, n= 15 |
|
|
| QT Interval, Day 9 post-dose, n= 15 |
|
|
| QTcF Interval, Day 1, 2 hours post-dose, n= 16 |
|
|
| QTcF Interval, Day 1, 4 hours post-dose, n= 16 |
|
|
| QTcF Interval, Day 4, Pre-dose, n= 15 |
|
|
| QTcF Interval, Day 4, 2 hours post-dose, n= 15 |
|
|
| QTcF Interval, Day 4, 4 hours post-dose, n= 15 |
|
|
| QTcF Interval, Day 7, Pre-dose, n= 15 |
|
|
| QTcF Interval, Day 7, 2 hours post-dose, n= 15 |
|
|
| QTcF Interval, Day 7, 4 hours post-dose, n= 15 |
|
|
| QTcF Interval, Day 9 post-dose, n= 15 |
|
|
| QTcB Interval, Day 1, 2 hours post-dose, n= 16 |
|
|
| QTcB Interval, Day 1, 4 hours post-dose, n= 16 |
|
|
| QTcB Interval, Day 4, Pre-dose, n= 15 |
|
|
| QTcB Interval, Day 4, 2 hours post-dose, n= 15 |
|
|
| QTcB Interval, Day 4, 4 hours post-dose, n= 15 |
|
|
| QTcB Interval, Day 7, Pre-dose, n= 15 |
|
|
| QTcB Interval, Day 7, 2 hours post-dose, n= 15 |
|
|
| QTcB Interval, Day 7, 4 hours post-dose, n= 15 |
|
|
| QTcB Interval, Day 9 post-dose, n= 15 |
|
|
|
| QRS Duration, Baseline |
|
| QRS Duration, Day 1, 2 hours post-dose |
|
| QRS Duration, Day 1, 4 hours post-dose |
|
| QT Interval, Baseline |
|
| QT Interval, Day 1, 2 hours post-dose |
|
| QT Interval, Day 1, 4 hours post-dose |
|
| QTcF Interval, Baseline |
|
| QTcF Interval, Day 1, 2 hours post-dose |
|
| QTcF Interval, Day 1, 4 hours post-dose |
|
| QTcB Interval, Baseline |
|
| QTcB Interval, Day 1, 2 hours post-dose |
|
| QTcB Interval, Day 1, 4 hours post-dose |
|
|
| PR Interval, Day 1, 4 hours post-dose, n= 16 |
|
|
| PR Interval, Day 4, Pre-dose, n= 15 |
|
|
| PR Interval, Day 4, 2 hours post-dose, n= 15 |
|
|
| PR Interval, Day 4, 4 hours post-dose, n= 15 |
|
|
| PR Interval, Day 7, Pre-dose, n= 15 |
|
|
| PR Interval, Day 7, 2 hours post-dose, n= 15 |
|
|
| PR Interval, Day 7, 4 hours post-dose, n= 15 |
|
|
| PR Interval, Day 9 post-dose, n= 15 |
|
|
| QRS Duration, Baseline, n= 16 |
|
|
| QRS Duration, Day 1, 2 hours post-dose, n= 16 |
|
|
| QRS Duration, Day 1, 4 hours post-dose, n= 16 |
|
|
| QRS Duration, Day 4, Pre-dose, n= 15 |
|
|
| QRS Duration, Day 4, 2 hours post-dose, n= 15 |
|
|
| QRS Duration, Day 4, 4 hours post-dose, n= 15 |
|
|
| QRS Duration, Day 7, Pre-dose, n= 15 |
|
|
| QRS Duration, Day 7, 2 hours post-dose, n= 15 |
|
|
| QRS Duration, Day 7, 4 hours post-dose, n= 15 |
|
|
| QRS Duration, Day 9 post-dose, n= 15 |
|
|
| QT Interval, Baseline, n= 16 |
|
|
| QT Interval, Day 1, 2 hours post-dose, n= 16 |
|
|
| QT Interval, Day 1, 4 hours post-dose, n= 16 |
|
|
| QT Interval, Day 4, Pre-dose, n= 15 |
|
|
| QT Interval, Day 4, 2 hours post-dose, n= 15 |
|
|
| QT Interval, Day 4, 4 hours post-dose, n= 15 |
|
|
| QT Interval, Day 7, Pre-dose, n= 15 |
|
|
| QT Interval, Day 7, 2 hours post-dose, n= 15 |
|
|
| QT Interval, Day 7, 4 hours post-dose, n= 15 |
|
|
| QT Interval, Day 9 post-dose, n= 15 |
|
|
| QTcF Interval, Baseline, n= 16 |
|
|
| QTcF Interval, Day 1, 2 hours, n= 16 |
|
|
| QTcF Interval, Day 1, 4 hours post-dose, n= 16 |
|
|
| QTcF Interval, Day 4, Pre-dose, n= 15 |
|
|
| QTcF Interval, Day 4, 2 hours post-dose, n= 15 |
|
|
| QTcF Interval, Day 4, 4 hours post-dose, n= 15 |
|
|
| QTcF Interval, Day 7, Pre-dose, n= 15 |
|
|
| QTcF Interval, Day 7, 2 hours post-dose, n= 15 |
|
|
| QTcF Interval, Day 7, 4 hours post-dose, n= 15 |
|
|
| QTcF Interval, Day 9 post-dose, n= 15 |
|
|
| QTcB Interval, Baseline, n= 16 |
|
|
| QTcB Interval, Day 1, 2 hours post-dose, n= 16 |
|
|
| QTcB Interval, Day 1, 4 hours post-dose, n= 16 |
|
|
| QTcB Interval, Day 4, Pre-dose, n= 15 |
|
|
| QTcB Interval, Day 4, 2 hours post-dose, n= 15 |
|
|
| QTcB Interval, Day 4, 4 hours post-dose, n= 15 |
|
|
| QTcB Interval, Day 7, Pre-dose, n= 15 |
|
|
| QTcB Interval, Day 7, 2 hours post-dose, n= 15 |
|
|
| QTcB Interval, Day 7, 4 hours post-dose, n= 15 |
|
|
| QTcB Interval, Day 9 post-dose, n= 15 |
|
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Day 7 |
|
| Title | Measurements |
|---|---|
|
| Day 10 |
|
| Title |
|---|
| Measurements |
|---|
|
| Day 4 |
|
| Day 5 |
|
| Day 7 |
|
|
| Day 7, n=15 |
|
|
| Day 9, n=15 |
|
|
| Day 10, n=15 |
|
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Day 7 |
|
| Title | Measurements |
|---|---|
|
| Day 10 |
|
| Title | Measurements |
|---|---|
|
| Day 4 |
|
| Day 5 |
|
| Day 7 |
|
|
| Day 7, n=15 |
|
|
| Day 9, n=15 |
|
|
| Day 10, n=15 |
|
|
| Title | Measurements |
|---|---|
|
| Day 5 |
|
| Day 7 |
|
| Title | Measurements |
|---|---|
|
| Day 10 |
|
| Title | Measurements |
|---|
|
| Day 4 |
|
| Day 5 |
|
| Day 7 |
|
|
| Day 7, n=15 |
|
|
| Day 9, n=15 |
|
|
| Day 10, n=15 |
|
|
| Title | Measurements |
|---|---|
|
| SBP, Day 5 |
|
| SBP, Day 7 |
|
| DBP, Day 2 |
|
| DBP, Day 3 |
|
| DBP, Day 4 |
|
| DBP, Day 5 |
|
| DBP, Day 7 |
|
| Title | Measurements |
|---|---|
|
| SBP, Day 10 |
|
| DBP, Day 4 |
|
| DBP, Day 7 |
|
| DBP, Day 9 |
|
| DBP, Day 10 |
|
| Title | Measurements |
|---|---|
|
| SBP, Day 4 |
|
| SBP, Day 5 |
|
| SBP, Day 7 |
|
| DBP, Baseline |
|
| DBP, Day 2 |
|
| DBP, Day 3 |
|
| DBP, Day 4 |
|
| DBP, Day 5 |
|
| DBP, Day 7 |
|
|
| SBP, Day 7, n=15 |
|
|
| SBP, Day 9, n=15 |
|
|
| SBP, Day 10, n=15 |
|
|
| DBP, Baseline, n= 16 |
|
|
| DBP, Day 4, n= 15 |
|
|
| DBP, Day 7, n= 15 |
|
|
| DBP, Day 9, n= 15 |
|
|
| DBP, Day 10, n= 15 |
|
|