HIV Infections
Conditions
Keywords
Human immunodeficiency virus, Sequential, Tenofovir alafenamide, Emtricitabine, GSK3640254
Brief summary
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.
Interventions
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.
DRUGGSK3640254
GSK3640254 will be available as 100 mg capsule. Subjects will be administered GSK3640254 200 mg capsule QD via the oral route.
Sponsors
ViiV Healthcare
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a fixed-sequence 2-period, one-way drug interaction study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Subjects who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG). * Body weight \>=50.0 kilograms (kg) (110 pound \[lbs\]) for men and \>=45.0 kilograms \[kg\] (99 lbs) for women and body mass index (BMI) within the range 18.5 to 31.0 kilograms per meter square (kg/m\^2) (inclusive). * Male or female; A female subject is eligible to participate if she is not pregnant, not breastfeeding and not a woman of childbearing potential (WOCBP). * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.
Exclusion criteria
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * A pre-existing condition interfering with normal gastrointestinal (GI) anatomy or motility (e.g.,gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism and/or excretion of the study drugs or render the subject unable to take oral study intervention. * Any history of significant underlying psychiatric disorder including, but not limited to, schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder. * Any history of major depressive disorder with or without suicidal features or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (\>6 months) outpatient treatment. Subjects with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (\<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the ViiV Medical Monitor. * Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the investigator (with or without psychiatric evaluation), could interfere with the subject's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the subject. * Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome. * History of any kidney disease or current or chronic history of impaired renal function as indicated by an estimated creatinine clearance \<80 milliliters per minute (mL/min). Creatinine clearance (CrCL) is estimated by either of the following methods: (a) The Modification of Diet in Renal Disease (MDRD) equation: estimated glomerular filtration rate (eGFR) (milliliter \[mL\]/minute \[min\]/1.73 meter square \[m\^2\]) = 175 x (SCr)\^-1.154 x (Age)\^-0.203 x 0.742 \[if female\] x 1.212 \[if African American\] glomerular filtration rate (GFR) is expressed in mL/min/1.73 m\^2, SCr is serum creatinine expressed in milligrams per deciliter (mg/dL), and age is expressed in years. (b)The Cockcroft-Gault equation: CrCL(mL/min) ={((l40-age) x weight)/(72xSCr)}x 0.85 (if female) CrCL is expressed in mL/min, age is expressed in years, weight is expressed in kg, and SCr is serum creatinine expressed in mg/dL. * Presence of Hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to starting study intervention. * Positive Hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention AND positive on reflex to Hepatitis C ribonucleic acid (RNA). * Positive HIV-1 and -2 antigen/antibody immunoassay at Screening. * ALT \>1.5 × upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility. * Bilirubin \>1.5 × ULN (isolated bilirubin \>1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound. * Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides, etc), and ALT (described above), will exclude a subject from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility. * A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine (indicating active current smoking) at Screening or before the first dose of study intervention. * Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication and for the duration of the study. * Treatment with any vaccine within 30 days prior to receiving study intervention. * Unwillingness to abstain from excessive consumption of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study intervention(s) until the end of the study. * Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the study intervention (whichever is longer). * Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days. * Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia-Suicide Severity Rating Scale (C-SSRS). * Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction, sinoatrial pauses, bundle branch block, or conduction abnormality) which, in the opinion of the investigator or VH/GSK Medical Monitor, will interfere with the safety for the individual subject. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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. |
| Period 2: AUC (0-tau) of TAF | 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 | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: Maximum Observed Concentration (Cmax) of TAF | 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 | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Cmax of TAF | 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 | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: AUC (0-tau) of FTC | 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 | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: AUC (0-tau) of FTC | 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 | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. |
| Period 1:Cmax of FTC | 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 | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2:Cmax of FTC | 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 | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC | 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 | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Ctau of FTC | 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 | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: AUC (0-tau) of Tenofovir (TFV) | 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 | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: AUC (0-tau) of TFV | 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 | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: Cmax of TFV | 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 | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Cmax of TFV | 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 | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: Ctau of TFV | 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 | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Ctau of TFV | 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 | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Period 2: Absolute Values of the Hematology Parameter: MCH | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) | Baseline and at Days 7, 14 | 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. |
| Period 2: Change From Baseline in Hematology Parameter of MCV | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Absolute Values of the Hematology Parameter: MCV | Baseline and at Days 7, 14 | Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. |
| Period 2: Absolute Values of the Hematology Parameter: MCV | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Change From Baseline in Hematology Parameter of Erythrocytes | Baseline and at Days 7, 14 | 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. |
| Period 2: Change From Baseline in Hematology Parameter of Erythrocytes | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Absolute Values of the Hematology Parameter: Erythrocytes | Baseline and at Days 7, 14 | Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. |
| Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Baseline and at Days 3, 7, 9 | 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. |
| Period 2: Absolute Values of the Hematology Parameter: Erythrocytes | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Baseline and at Days 7, 14 | 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. |
| 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 | Baseline and at Days 7, 14 | 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. |
| Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Baseline and at Days 7, 14 | 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. |
| Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Baseline and at Days 3, 7, 9 | 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. |
| 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) | Baseline and at Days 7, 14 | 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. |
| Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Baseline and at Days 7, 14 | 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. |
| Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase | Baseline and at Days 7, 14 | 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. |
| Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Baseline and at Days 7, 14 | 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. |
| Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Baseline and at Days 7, 14 | 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. |
| Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Baseline and at Days 7, 14 | 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. |
| Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Baseline and at Days 7, 14 | 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. |
| Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Change From Baseline in Specific Gravity of Urine | Baseline and at Days 7, 14 | 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. |
| Period 2: Change From Baseline in Specific Gravity of Urine | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Absolute Values of Specific Gravity of Urine | Baseline and at Days 7, 14 | 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. |
| Period 2: Absolute Values of Specific Gravity of Urine | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine | Baseline and at Days 7, 14 | 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. |
| Period 2: Change From Baseline in pH of Urine | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Absolute Values of pH of Urine | Baseline and at Days 7, 14 | 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. |
| Period 2: Absolute Values of pH of Urine | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Change From Baseline in Urine Urobilinogen | Baseline and at Days 7, 14 | 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. |
| Period 2: Change From Baseline in Urine Urobilinogen | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Absolute Values of Urine Urobilinogen | Baseline and at Days 7, 14 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. |
| Period 2: Absolute Values of Urine Urobilinogen | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Change From Baseline in Heart Rate | Baseline and at Day 1, 2 and 4 hours post-dose | 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. |
| Period 2: Change From Baseline in Heart Rate | 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 | 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. |
| Period 1: Absolute Values of Heart Rate | Baseline and at Day 1, 2 and 4 hours post-dose | 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. |
| Period 2: Absolute Values of Heart Rate | 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 | 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. |
| 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 | Baseline and at Day 1, 2 and 4 hours post-dose | 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. |
| Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | 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 | 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. |
| Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | Baseline and at Day 1, 2 and 4 hours post-dose | 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. |
| Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | 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 | 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. |
| Period 1: Change From Baseline in Temperature | Baseline and at Days 2, 3, 4, 5 and 7 | 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. |
| Period 1: Absolute Values of the Hematology Parameter: Hemoglobin | Baseline and at Days 7, 14 | Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. |
| Period 1: Absolute Values of Temperature | Baseline and at Days 2, 3, 4, 5 and 7 | Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. |
| Period 2: Absolute Values of Temperature | Baseline and at Days 4, 7, 9, and 10 | Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. |
| Period 1: Change From Baseline in Pulse Rate | Baseline and at Days 2, 3, 4, 5 and 7 | 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. |
| Period 2: Change From Baseline in Pulse Rate | Baseline and at Days 4, 7, 9, and 10 | 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. |
| Period 1: Absolute Values of Pulse Rate | Baseline and at Days 2, 3, 4, 5 and 7 | 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. |
| Period 2: Absolute Values of Pulse Rate | Baseline and at Days 4, 7, 9, and 10 | 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. |
| Period 1: Change From Baseline in Respiratory Rate | Baseline and at Days 2, 3, 4, 5 and 7 | 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. |
| Period 2: Change From Baseline in Respiratory Rate | Baseline and at Days 4, 7, 9, and 10 | 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. |
| Period 1: Absolute Values of Respiratory Rate | Baseline and at Days 2, 3, 4, 5 and 7 | Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. |
| Period 2: Absolute Values of Respiratory Rate | Baseline and at Days 4, 7, 9, and 10 | Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. |
| Period 1: Change From Baseline in Blood Pressure | Baseline and at Days 2, 3, 4, 5 and 7 | 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. |
| Period 2: Change From Baseline in Blood Pressure | Baseline and at Days 4, 7, 9, and 10 | 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. |
| Period 1: Absolute Values of Blood Pressure | Baseline and at Days 2, 3, 4, 5 and 7 | 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. |
| Period 2: Absolute Values of Blood Pressure | Baseline and at Days 4, 7, 9, and 10 | 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. |
| Period 2: AUC (0-tau) of GSK3640254 | 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 | Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Cmax of GSK3640254 | 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 | Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Ctau of GSK3640254 | 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 | Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 | 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 | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: Tmax of TAF | 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 | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Tmax of TAF | 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 | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: Tmax of FTC | 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 | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Tmax of FTC | 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 | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: Tmax of TFV | 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 | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Tmax of TFV | 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 | Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Change From Baseline in Temperature | Baseline and at Days 4, 7, 9, and 10 | 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. |
| Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) | Up to Day 24 | 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 |
| Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Baseline and at Days 7, and 14 | 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. |
| Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Baseline and at Days 7, and 14 | 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. |
| Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Change From Baseline in Hematology Parameter of Hematocrit | Baseline and at Days 7, 14 | 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. |
| Period 2: Change From Baseline in Hematology Parameter of Hematocrit | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Absolute Values of the Hematology Parameter: Hematocrit | Baseline and at Days 7, 14 | Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. |
| Period 2: Absolute Values of the Hematology Parameter: Hematocrit | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Change From Baseline in Hematology Parameter of Hemoglobin | Baseline and at Days 7, 14 | 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. |
| Period 2: Change From Baseline in Hematology Parameter of Hemoglobin | Baseline and at Days 3, 7, 9 | 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. |
| Period 2: Absolute Values of the Hematology Parameter: Hemoglobin | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) | Baseline and at Days 7, 14 | 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. |
| Period 2: Change From Baseline in Hematology Parameter of MCH | Baseline and at Days 3, 7, 9 | 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. |
| Period 1: Absolute Values of the Hematology Parameter: MCH | Baseline and at Days 7, 14 | Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
A total of 16 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Treatment Period 2 (Up to Day 7) | Adverse Event | 1 |
Baseline characteristics
| Characteristic | TAF/FTC Followed by TAF/FTC+GSK3640254 |
|---|---|
| Age, Continuous | 33.9 Years STANDARD_DEVIATION 9.67 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian: East Asian Heritage | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other pacific islander | 1 Participants |
| Race/Ethnicity, Customized White:White/Caucasian/European Heritage | 6 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 9 / 16 | 3 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | 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 | 250.4 Hours*nanogram per milliliter | Geometric Coefficient of Variation 58.2 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 1: AUC (0-tau) of FTC | 9787.5 Hours*nanogram per milliliter | Geometric Coefficient of Variation 15.5 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 1: AUC (0-tau) of Tenofovir (TFV) | 221.9 Hours*nanogram per milliliter | Geometric Coefficient of Variation 18.3 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 1:Cmax of FTC | 1811 Nanogram per milliliter | Geometric Coefficient of Variation 15.9 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 1: Cmax of TFV | 13.14 Nanogram per milliliter | Geometric Coefficient of Variation 17.8 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 1: Ctau of TFV | 7.688 Nanogram per milliliter | Geometric Coefficient of Variation 20.4 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 1: Maximum Observed Concentration (Cmax) of TAF | 203.4 Nanogram per milliliter | Geometric Coefficient of Variation 56.1 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC | 71.81 Nanogram per milliliter | Geometric Coefficient of Variation 25.5 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 2: AUC (0-tau) of FTC | 9421.0 Hours*nanogram per milliliter | Geometric Coefficient of Variation 14.4 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 2: AUC (0-tau) of TAF | 215.4 Hours*nanogram per milliliter | Geometric Coefficient of Variation 36.3 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 2: AUC (0-tau) of TFV | 229.1 Hours*nanogram per milliliter | Geometric Coefficient of Variation 21.5 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 2:Cmax of FTC | 1701 Nanogram per milliliter | Geometric Coefficient of Variation 20.9 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 2: Cmax of TAF | 175.1 Nanogram per milliliter | Geometric Coefficient of Variation 44.4 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 2: Cmax of TFV | 13.30 Nanogram per milliliter | Geometric Coefficient of Variation 20.8 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 2: Ctau of FTC | 82.92 Nanogram per milliliter | Geometric Coefficient of Variation 29.1 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 2: Ctau of TFV | 8.244 Nanogram per milliliter | Geometric Coefficient of Variation 22.9 |
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
Time frame: Up to Day 24
Population: Safety Population included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAF/FTC | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) | Non-SAEs | 9 Participants |
| TAF/FTC | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) | SAEs | 0 Participants |
| TAF/FTC+GSK3640254 | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) | Non-SAEs | 3 Participants |
| TAF/FTC+GSK3640254 | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) | SAEs | 0 Participants |
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.
Time frame: Baseline and at Days 2, 3, 4, 5 and 7
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of Blood Pressure | SBP, Baseline | 123.3 Millimeters of mercury | Standard Deviation 8.27 |
| TAF/FTC | Period 1: Absolute Values of Blood Pressure | SBP, Day 2 | 124.7 Millimeters of mercury | Standard Deviation 9.6 |
| TAF/FTC | Period 1: Absolute Values of Blood Pressure | SBP, Day 3 | 121.5 Millimeters of mercury | Standard Deviation 7.7 |
| TAF/FTC | Period 1: Absolute Values of Blood Pressure | SBP, Day 4 | 120.6 Millimeters of mercury | Standard Deviation 8.47 |
| TAF/FTC | Period 1: Absolute Values of Blood Pressure | SBP, Day 5 | 121.0 Millimeters of mercury | Standard Deviation 6.95 |
| TAF/FTC | Period 1: Absolute Values of Blood Pressure | SBP, Day 7 | 124.1 Millimeters of mercury | Standard Deviation 10.56 |
| TAF/FTC | Period 1: Absolute Values of Blood Pressure | DBP, Baseline | 75.3 Millimeters of mercury | Standard Deviation 5.22 |
| TAF/FTC | Period 1: Absolute Values of Blood Pressure | DBP, Day 2 | 75.4 Millimeters of mercury | Standard Deviation 9.08 |
| TAF/FTC | Period 1: Absolute Values of Blood Pressure | DBP, Day 3 | 73.8 Millimeters of mercury | Standard Deviation 5.69 |
| TAF/FTC | Period 1: Absolute Values of Blood Pressure | DBP, Day 4 | 75.4 Millimeters of mercury | Standard Deviation 10.42 |
| TAF/FTC | Period 1: Absolute Values of Blood Pressure | DBP, Day 5 | 73.9 Millimeters of mercury | Standard Deviation 5.46 |
| TAF/FTC | Period 1: Absolute Values of Blood Pressure | DBP, Day 7 | 78.2 Millimeters of mercury | Standard Deviation 7.57 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase | Amylase, Baseline | 56.4 Units per Liter | Standard Deviation 14.66 |
| TAF/FTC | Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase | Lipase, Baseline | 22.2 Units per Liter | Standard Deviation 14 |
| TAF/FTC | Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase | Lipase, Day 7 | 18.2 Units per Liter | Standard Deviation 9.72 |
| TAF/FTC | Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase | Lipase, Day 14 | 16.9 Units per Liter | Standard Deviation 14.65 |
| TAF/FTC | Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase | Amylase, Day 7 | 54.1 Units per Liter | Standard Deviation 13.15 |
| TAF/FTC | Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase | Amylase, Day 14 | 53.6 Units per Liter | Standard Deviation 14.48 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Alkaline phosphatase, Baseline | 60.9 International units per Liter | Standard Deviation 9.33 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Alkaline phosphatase, Day 7 | 58.3 International units per Liter | Standard Deviation 8.36 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | LDH, Day 7 | 123.4 International units per Liter | Standard Deviation 19.67 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | LDH, Day 9 | 126.0 International units per Liter | Standard Deviation 19.5 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | CK, Baseline | 219.6 International units per Liter | Standard Deviation 150.9 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | CK, Day 7 | 116.6 International units per Liter | Standard Deviation 49.16 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Alkaline phosphatase, Day 14 | 63.4 International units per Liter | Standard Deviation 8.82 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | AST, Baseline | 24.6 International units per Liter | Standard Deviation 6.16 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | AST, Day 7 | 18.4 International units per Liter | Standard Deviation 4.79 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | AST, Day 14 | 17.6 International units per Liter | Standard Deviation 3.46 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | ALT, Baseline | 26.6 International units per Liter | Standard Deviation 10.44 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | ALT, Day 7 | 24.4 International units per Liter | Standard Deviation 13.28 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | ALT, Day 14 | 20.4 International units per Liter | Standard Deviation 8.59 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | GGT Baseline | 1.76 International units per Liter | Standard Deviation 1.016 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | GGT Day 7 | 1.91 International units per Liter | Standard Deviation 0.752 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | GGT Day 14 | 2.40 International units per Liter | Standard Deviation 1.035 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | LDH, Baseline | 138.0 International units per Liter | Standard Deviation 19.77 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | CK, Day 14 | 120.4 International units per Liter | Standard Deviation 62.41 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Glucose, Baseline | 5.111 Millimoles per Liter | Standard Deviation 0.3747 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Glucose, Day 14 | 4.791 Millimoles per Liter | Standard Deviation 0.2662 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Cholesterol, Baseline | 4.253 Millimoles per Liter | Standard Deviation 0.7938 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Potassium, Day 14 | 4.22 Millimoles per Liter | Standard Deviation 0.279 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Sodium, Baseline | 139.4 Millimoles per Liter | Standard Deviation 1.45 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | BUN, Day 7 | 4.423 Millimoles per Liter | Standard Deviation 0.9623 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | BUN, Day 14 | 4.246 Millimoles per Liter | Standard Deviation 0.782 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Glucose, Day 7 | 4.951 Millimoles per Liter | Standard Deviation 0.2587 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Cholesterol, Day 7 | 4.249 Millimoles per Liter | Standard Deviation 0.8494 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Cholesterol, Day 14 | 3.864 Millimoles per Liter | Standard Deviation 0.6087 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Anion gap, Baseline | 8.7 Millimoles per Liter | Standard Deviation 1.08 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Anion gap, Day 7 | 10.6 Millimoles per Liter | Standard Deviation 2.25 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Anion gap, Day 14 | 10.9 Millimoles per Liter | Standard Deviation 1.45 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Calcium, Baseline | 2.359 Millimoles per Liter | Standard Deviation 0.0697 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Calcium, Day 7 | 2.387 Millimoles per Liter | Standard Deviation 0.0663 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Calcium, Day 14 | 2.387 Millimoles per Liter | Standard Deviation 0.0637 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | CO2, Baseline | 31.7 Millimoles per Liter | Standard Deviation 1.49 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | CO2, Day 7 | 30.1 Millimoles per Liter | Standard Deviation 1.86 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | CO2, Day 14 | 30.8 Millimoles per Liter | Standard Deviation 1.38 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Chloride, Baseline | 103.3 Millimoles per Liter | Standard Deviation 1.84 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Chloride, Day 7 | 102.2 Millimoles per Liter | Standard Deviation 1.72 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Chloride, Day 14 | 101.3 Millimoles per Liter | Standard Deviation 2.32 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Phosphate, Baseline | 1.078 Millimoles per Liter | Standard Deviation 0.1301 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Phosphate, Day 7 | 1.094 Millimoles per Liter | Standard Deviation 0.1202 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Phosphate, Day 14 | 1.103 Millimoles per Liter | Standard Deviation 0.0807 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Potassium, Baseline | 4.25 Millimoles per Liter | Standard Deviation 0.225 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Potassium, Day 7 | 4.28 Millimoles per Liter | Standard Deviation 0.161 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Sodium, Day 7 | 138.8 Millimoles per Liter | Standard Deviation 1.77 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Sodium, Day 14 | 138.8 Millimoles per Liter | Standard Deviation 1.69 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Triglycerides, Baseline | 1.076 Millimoles per Liter | Standard Deviation 0.5825 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Triglycerides, Day 7 | 1.168 Millimoles per Liter | Standard Deviation 0.3759 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Triglycerides, Day 14 | 1.033 Millimoles per Liter | Standard Deviation 0.3034 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | BUN, Baseline | 4.441 Millimoles per Liter | Standard Deviation 1.2792 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Creatinine, Baseline | 80.16 Micromoles per liter | Standard Deviation 10.103 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Creatinine, Day 7 | 85.85 Micromoles per liter | Standard Deviation 9.586 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Creatinine, Day 14 | 87.52 Micromoles per liter | Standard Deviation 10.058 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Total bilirubin, Baseline | 9.64 Micromoles per liter | Standard Deviation 6.143 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Total bilirubin, Day 7 | 11.89 Micromoles per liter | Standard Deviation 6.781 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Total bilirubin, Day 14 | 11.74 Micromoles per liter | Standard Deviation 7.046 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Direct bilirubin, Baseline | 1.76 Micromoles per liter | Standard Deviation 1.016 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Direct bilirubin, Day 7 | 1.91 Micromoles per liter | Standard Deviation 0.752 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Direct bilirubin, Day 14 | 2.40 Micromoles per liter | Standard Deviation 1.035 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Total Protein, Baseline | 69.8 Grams per Liter | Standard Deviation 3.64 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Total Protein, Day 7 | 72.4 Grams per Liter | Standard Deviation 3.7 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Total Protein, Day 14 | 72.6 Grams per Liter | Standard Deviation 3.1 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Globulin, Baseline | 25.9 Grams per Liter | Standard Deviation 2.5 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Globulin, Day 7 | 28.4 Grams per Liter | Standard Deviation 2.6 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Globulin, Day 14 | 28.7 Grams per Liter | Standard Deviation 1.99 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Albumin, Baseline | 43.9 Grams per Liter | Standard Deviation 2.36 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Albumin, Day 7 | 44.0 Grams per Liter | Standard Deviation 1.9 |
| TAF/FTC | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Albumin, Day 14 | 43.9 Grams per Liter | Standard Deviation 2.41 |
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.
Time frame: Baseline and at Day 1, 2 and 4 hours post-dose
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 1, 4 hours post-dose | 393.3 Milliseconds | Standard Deviation 18.26 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Baseline | 161.3 Milliseconds | Standard Deviation 16.53 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 1, 2 hours post-dose | 162.8 Milliseconds | Standard Deviation 19.01 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 1, 4 hours post-dose | 159.4 Milliseconds | Standard Deviation 19.47 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Baseline | 91.0 Milliseconds | Standard Deviation 8.22 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 1, 2 hours post-dose | 89.9 Milliseconds | Standard Deviation 7.54 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 1, 4 hours post-dose | 91.3 Milliseconds | Standard Deviation 8.14 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Baseline | 377.8 Milliseconds | Standard Deviation 24.84 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 1, 2 hours post-dose | 370.3 Milliseconds | Standard Deviation 24.74 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 1, 4 hours post-dose | 383.6 Milliseconds | Standard Deviation 32.12 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Baseline | 391.6 Milliseconds | Standard Deviation 12.92 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 1, 2 hours post-dose | 386.7 Milliseconds | Standard Deviation 14.33 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 1, 4 hours post-dose | 390.3 Milliseconds | Standard Deviation 18.27 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Baseline | 398.8 Milliseconds | Standard Deviation 11.28 |
| TAF/FTC | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 1, 2 hours post-dose | 394.6 Milliseconds | Standard Deviation 15.14 |
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.
Time frame: Baseline and at Day 1, 2 and 4 hours post-dose
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of Heart Rate | Baseline | 67.6 Beats per minute | Standard Deviation 8.72 |
| TAF/FTC | Period 1: Absolute Values of Heart Rate | Day 1, 2 hours post-dose | 69.1 Beats per minute | Standard Deviation 11.04 |
| TAF/FTC | Period 1: Absolute Values of Heart Rate | Day 1, 4 hours post-dose | 64.4 Beats per minute | Standard Deviation 11.87 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of pH of Urine | Baseline | 6.22 pH | Standard Deviation 0.446 |
| TAF/FTC | Period 1: Absolute Values of pH of Urine | Day 7 | 5.88 pH | Standard Deviation 0.289 |
| TAF/FTC | Period 1: Absolute Values of pH of Urine | Day 14 | 6.03 pH | Standard Deviation 0.531 |
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.
Time frame: Baseline and at Days 2, 3, 4, 5 and 7
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of Pulse Rate | Baseline | 73.9 Beats per minute | Standard Deviation 9.24 |
| TAF/FTC | Period 1: Absolute Values of Pulse Rate | Day 2 | 72.8 Beats per minute | Standard Deviation 10.14 |
| TAF/FTC | Period 1: Absolute Values of Pulse Rate | Day 3 | 70.1 Beats per minute | Standard Deviation 11.18 |
| TAF/FTC | Period 1: Absolute Values of Pulse Rate | Day 4 | 69.9 Beats per minute | Standard Deviation 10.81 |
| TAF/FTC | Period 1: Absolute Values of Pulse Rate | Day 5 | 72.3 Beats per minute | Standard Deviation 12.38 |
| TAF/FTC | Period 1: Absolute Values of Pulse Rate | Day 7 | 66.3 Beats per minute | Standard Deviation 10.2 |
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.
Time frame: Baseline and at Days 2, 3, 4, 5 and 7
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of Respiratory Rate | Baseline | 14.0 Breaths per minute | Standard Deviation 1.63 |
| TAF/FTC | Period 1: Absolute Values of Respiratory Rate | Day 2 | 12.5 Breaths per minute | Standard Deviation 1.37 |
| TAF/FTC | Period 1: Absolute Values of Respiratory Rate | Day 3 | 13.5 Breaths per minute | Standard Deviation 2.48 |
| TAF/FTC | Period 1: Absolute Values of Respiratory Rate | Day 4 | 13.5 Breaths per minute | Standard Deviation 2 |
| TAF/FTC | Period 1: Absolute Values of Respiratory Rate | Day 5 | 15.3 Breaths per minute | Standard Deviation 2.05 |
| TAF/FTC | Period 1: Absolute Values of Respiratory Rate | Day 7 | 14.6 Breaths per minute | Standard Deviation 2.7 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of Specific Gravity of Urine | Baseline | 1.0136 Ratio | Standard Deviation 0.01095 |
| TAF/FTC | Period 1: Absolute Values of Specific Gravity of Urine | Day 7 | 1.0143 Ratio | Standard Deviation 0.00556 |
| TAF/FTC | Period 1: Absolute Values of Specific Gravity of Urine | Day 14 | 1.0147 Ratio | Standard Deviation 0.00789 |
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.
Time frame: Baseline and at Days 2, 3, 4, 5 and 7
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of Temperature | Baseline | 36.49 Degree Celsius | Standard Deviation 0.298 |
| TAF/FTC | Period 1: Absolute Values of Temperature | Day 3 | 36.34 Degree Celsius | Standard Deviation 0.456 |
| TAF/FTC | Period 1: Absolute Values of Temperature | Day 2 | 36.33 Degree Celsius | Standard Deviation 0.342 |
| TAF/FTC | Period 1: Absolute Values of Temperature | Day 4 | 36.41 Degree Celsius | Standard Deviation 0.431 |
| TAF/FTC | Period 1: Absolute Values of Temperature | Day 5 | 36.34 Degree Celsius | Standard Deviation 0.36 |
| TAF/FTC | Period 1: Absolute Values of Temperature | Day 7 | 36.25 Degree Celsius | Standard Deviation 0.407 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: Erythrocytes | Baseline | 4.977 Trillion cells per liter | Standard Deviation 0.3351 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: Erythrocytes | Day 7 | 5.166 Trillion cells per liter | Standard Deviation 0.3679 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: Erythrocytes | Day 14 | 5.203 Trillion cells per liter | Standard Deviation 0.3604 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: Hematocrit | Baseline | 0.4264 Proportion of red blood cells in blood | Standard Deviation 0.01891 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: Hematocrit | Day 7 | 0.4384 Proportion of red blood cells in blood | Standard Deviation 0.02358 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: Hematocrit | Day 14 | 0.4453 Proportion of red blood cells in blood | Standard Deviation 0.01997 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: Hemoglobin | Baseline | 142.0 Grams per liter | Standard Deviation 6.7 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: Hemoglobin | Day 7 | 148.1 Grams per liter | Standard Deviation 8.11 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: Hemoglobin | Day 14 | 150.4 Grams per liter | Standard Deviation 7.45 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: MCH | Baseline | 28.63 Picograms | Standard Deviation 1.78 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: MCH | Day 7 | 28.75 Picograms | Standard Deviation 1.687 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: MCH | Day 14 | 28.98 Picograms | Standard Deviation 1.69 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: MCV | Baseline | 85.92 Femtoliters | Standard Deviation 4.69 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: MCV | Day 7 | 85.09 Femtoliters | Standard Deviation 4.504 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter: MCV | Day 14 | 85.85 Femtoliters | Standard Deviation 4.492 |
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.
Time frame: Baseline and at Days 7, and 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils, Period 1 Baseline | 0.046 Giga cells per liter | Standard Deviation 0.0216 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils, Period 1 Day 14 | 0.205 Giga cells per liter | Standard Deviation 0.1766 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes, Period 1 Baseline | 0.522 Giga cells per liter | Standard Deviation 0.1147 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Leukocytes, Period 1 Day 7 | 6.10 Giga cells per liter | Standard Deviation 2.024 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils, Period 1 Day 7 | 3.628 Giga cells per liter | Standard Deviation 1.9503 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelets, Period 1 Day 14 | 275.1 Giga cells per liter | Standard Deviation 53.39 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils, Period 1 Day 7 | 0.041 Giga cells per liter | Standard Deviation 0.0189 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils, Period 1 Day 14 | 0.040 Giga cells per liter | Standard Deviation 0.0256 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils, Period 1 Baseline | 0.225 Giga cells per liter | Standard Deviation 0.1918 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils, Period 1 Day 7 | 0.204 Giga cells per liter | Standard Deviation 0.1737 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes, Period 1 Day 7 | 0.536 Giga cells per liter | Standard Deviation 0.2063 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes, Period 1 Day 14 | 0.571 Giga cells per liter | Standard Deviation 0.283 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Leukocytes, Period 1 Baseline | 6.18 Giga cells per liter | Standard Deviation 1.336 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Leukocytes, Period 1 Day 14 | 6.45 Giga cells per liter | Standard Deviation 2.231 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes, Period 1 Baseline | 1.945 Giga cells per liter | Standard Deviation 0.7419 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes, Period 1 Day 7 | 1.699 Giga cells per liter | Standard Deviation 0.5822 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes, Period 1 Day 14 | 1.683 Giga cells per liter | Standard Deviation 0.4988 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils, Period 1 Baseline | 3.441 Giga cells per liter | Standard Deviation 0.9719 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils, Period 1 Day 14 | 3.954 Giga cells per liter | Standard Deviation 1.9141 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelets, Period 1 Baseline | 253.3 Giga cells per liter | Standard Deviation 49.81 |
| TAF/FTC | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelets, Period 1 Day 7 | 256.6 Giga cells per liter | Standard Deviation 49.72 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Absolute Values of Urine Urobilinogen | Baseline | 5.9255 Micromoles per liter | Standard Deviation 5.45976 |
| TAF/FTC | Period 1: Absolute Values of Urine Urobilinogen | Day 7 | 3.3860 Micromoles per liter | Standard Deviation 0 |
| TAF/FTC | Period 1: Absolute Values of Urine Urobilinogen | Day 14 | 3.3860 Micromoles per liter | Standard Deviation 0 |
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.
Time frame: Baseline and at Days 2, 3, 4, 5 and 7
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Blood Pressure | SBP, Day 2 | 1.4 Millimeters of mercury | Standard Deviation 8.96 |
| TAF/FTC | Period 1: Change From Baseline in Blood Pressure | SBP, Day 3 | -1.8 Millimeters of mercury | Standard Deviation 8.54 |
| TAF/FTC | Period 1: Change From Baseline in Blood Pressure | SBP, Day 4 | -2.7 Millimeters of mercury | Standard Deviation 6.16 |
| TAF/FTC | Period 1: Change From Baseline in Blood Pressure | SBP, Day 5 | -2.3 Millimeters of mercury | Standard Deviation 8.81 |
| TAF/FTC | Period 1: Change From Baseline in Blood Pressure | SBP, Day 7 | 0.8 Millimeters of mercury | Standard Deviation 9.47 |
| TAF/FTC | Period 1: Change From Baseline in Blood Pressure | DBP, Day 2 | 0.1 Millimeters of mercury | Standard Deviation 8.33 |
| TAF/FTC | Period 1: Change From Baseline in Blood Pressure | DBP, Day 3 | -1.6 Millimeters of mercury | Standard Deviation 7.2 |
| TAF/FTC | Period 1: Change From Baseline in Blood Pressure | DBP, Day 4 | 0.1 Millimeters of mercury | Standard Deviation 7.89 |
| TAF/FTC | Period 1: Change From Baseline in Blood Pressure | DBP, Day 5 | -1.4 Millimeters of mercury | Standard Deviation 6.2 |
| TAF/FTC | Period 1: Change From Baseline in Blood Pressure | DBP, Day 7 | 2.9 Millimeters of mercury | Standard Deviation 7.58 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | 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) | AST, Day 14 | -6.9 International units per Liter | Standard Deviation 4.95 |
| TAF/FTC | 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) | ALT, Day 7 | -2.1 International units per Liter | Standard Deviation 7.26 |
| TAF/FTC | 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) | ALT, Day 14 | -6.2 International units per Liter | Standard Deviation 6.98 |
| TAF/FTC | 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) | LDH, Day 14 | -12.0 International units per Liter | Standard Deviation 16.25 |
| TAF/FTC | 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) | CK, Day 7 | -103.0 International units per Liter | Standard Deviation 127.1 |
| TAF/FTC | 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) | Alkaline phosphatase, Day 7 | -2.6 International units per Liter | Standard Deviation 5.1 |
| TAF/FTC | 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) | Alkaline phosphatase, Day 14 | 2.4 International units per Liter | Standard Deviation 6.91 |
| TAF/FTC | 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) | AST, Day 7 | -6.2 International units per Liter | Standard Deviation 4.59 |
| TAF/FTC | 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) | GGT Day 7 | 0.2 International units per Liter | Standard Deviation 2.32 |
| TAF/FTC | 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) | GGT Day 14 | -1.7 International units per Liter | Standard Deviation 3.63 |
| TAF/FTC | 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) | LDH, Day 7 | -14.6 International units per Liter | Standard Deviation 13.07 |
| TAF/FTC | 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) | CK, Day 14 | -99.2 International units per Liter | Standard Deviation 135.8 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | 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 | Cholesterol, Day 7 | -0.004 Millimoles per Liter | Standard Deviation 0.3735 |
| TAF/FTC | 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 | Calcium, Day 14 | 0.028 Millimoles per Liter | Standard Deviation 0.0556 |
| TAF/FTC | 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 | CO2, Day 7 | -1.6 Millimoles per Liter | Standard Deviation 1.93 |
| TAF/FTC | 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 | Chloride, Day 7 | -1.1 Millimoles per Liter | Standard Deviation 1.06 |
| TAF/FTC | 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 | Chloride, Day 14 | -2.0 Millimoles per Liter | Standard Deviation 1.46 |
| TAF/FTC | 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 | Phosphate, Day 7 | 0.017 Millimoles per Liter | Standard Deviation 0.096 |
| TAF/FTC | 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 | Sodium, Day 7 | -0.6 Millimoles per Liter | Standard Deviation 1.45 |
| TAF/FTC | 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 | Sodium, Day 14 | -0.6 Millimoles per Liter | Standard Deviation 1.59 |
| TAF/FTC | 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 | Triglycerides, Day 7 | 0.092 Millimoles per Liter | Standard Deviation 0.4841 |
| TAF/FTC | 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 | Glucose, Day 7 | -0.160 Millimoles per Liter | Standard Deviation 0.3793 |
| TAF/FTC | 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 | Glucose, Day 14 | -0.320 Millimoles per Liter | Standard Deviation 0.3432 |
| TAF/FTC | 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 | Cholesterol, Day 14 | -0.389 Millimoles per Liter | Standard Deviation 0.3533 |
| TAF/FTC | 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 | Anion gap, Day 7 | 1.9 Millimoles per Liter | Standard Deviation 2.08 |
| TAF/FTC | 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 | Anion gap, Day 14 | 2.2 Millimoles per Liter | Standard Deviation 1.42 |
| TAF/FTC | 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 | Calcium, Day 7 | 0.028 Millimoles per Liter | Standard Deviation 0.078 |
| TAF/FTC | 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 | CO2, Day 14 | -0.9 Millimoles per Liter | Standard Deviation 1.2 |
| TAF/FTC | 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 | Phosphate, Day 14 | 0.026 Millimoles per Liter | Standard Deviation 0.133 |
| TAF/FTC | 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 | Potassium, Day 7 | 0.03 Millimoles per Liter | Standard Deviation 0.304 |
| TAF/FTC | 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 | Potassium, Day 14 | -0.03 Millimoles per Liter | Standard Deviation 0.328 |
| TAF/FTC | 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 | Triglycerides, Day 14 | -0.044 Millimoles per Liter | Standard Deviation 0.4569 |
| TAF/FTC | 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 | BUN, Day 7 | -0.018 Millimoles per Liter | Standard Deviation 1.2157 |
| TAF/FTC | 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 | BUN, Day 14 | -0.195 Millimoles per Liter | Standard Deviation 1.064 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Amylase, Day 7 | -2.3 Units per Liter | Standard Deviation 9.68 |
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Amylase, Day 14 | -2.8 Units per Liter | Standard Deviation 10.48 |
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Lipase, Day 7 | -4.0 Units per Liter | Standard Deviation 8.93 |
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Lipase, Day 14 | -5.3 Units per Liter | Standard Deviation 12.69 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Creatinine, Day 7 | 5.69 Micromoles per liter | Standard Deviation 3.508 |
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Creatinine, Day 14 | 7.36 Micromoles per liter | Standard Deviation 4.833 |
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Total bilirubin, Day 7 | 2.25 Micromoles per liter | Standard Deviation 4.756 |
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Total bilirubin, Day 14 | 2.10 Micromoles per liter | Standard Deviation 5.109 |
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Direct bilirubin, Day 7 | 0.15 Micromoles per liter | Standard Deviation 0.634 |
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Direct bilirubin, Day 14 | 0.64 Micromoles per liter | Standard Deviation 0.699 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Total Protein, Day 7 | 2.6 Grams per Liter | Standard Deviation 3.2 |
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Total Protein, Day 14 | 2.9 Grams per Liter | Standard Deviation 2.66 |
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Globulin, Day 7 | 2.5 Grams per Liter | Standard Deviation 1.37 |
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Globulin, Day 14 | 2.8 Grams per Liter | Standard Deviation 1.91 |
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Albumin, Day 7 | 0.1 Grams per Liter | Standard Deviation 2.22 |
| TAF/FTC | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Albumin, Day 14 | 0.1 Grams per Liter | Standard Deviation 2.05 |
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.
Time frame: Baseline and at Day 1, 2 and 4 hours post-dose
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | 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 | PR Interval, Day 1, 2 hours post-dose | 1.5 Milliseconds | Standard Deviation 9.67 |
| TAF/FTC | 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 | PR Interval, Day 1, 4 hours post-dose | -1.9 Milliseconds | Standard Deviation 8.64 |
| TAF/FTC | 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 | QRS Duration, Day 1, 2 hours post-dose | -1.1 Milliseconds | Standard Deviation 3.68 |
| TAF/FTC | 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 | QRS Duration, Day 1, 4 hours post-dose | 0.3 Milliseconds | Standard Deviation 4.96 |
| TAF/FTC | 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 | QT Interval, Day 1, 2 hours post-dose | -7.5 Milliseconds | Standard Deviation 14.12 |
| TAF/FTC | 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 | QT Interval, Day 1, 4 hours post-dose | 5.8 Milliseconds | Standard Deviation 23.18 |
| TAF/FTC | 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 | QTcF Interval, Day 1, 2 hours post-dose | -4.9 Milliseconds | Standard Deviation 10.63 |
| TAF/FTC | 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 | QTcF Interval, Day 1, 4 hours post-dose | -1.3 Milliseconds | Standard Deviation 10.56 |
| TAF/FTC | 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 | QTcB Interval, Day 1, 2 hours post-dose | -4.1 Milliseconds | Standard Deviation 12.7 |
| TAF/FTC | 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 | QTcB Interval, Day 1, 4 hours post-dose | -5.4 Milliseconds | Standard Deviation 12.39 |
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.
Time frame: Baseline and at Day 1, 2 and 4 hours post-dose
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Heart Rate | Day 1, 2 hours post-dose | 1.5 Beats per minute | Standard Deviation 6.87 |
| TAF/FTC | Period 1: Change From Baseline in Heart Rate | Day 1, 4 hours post-dose | -3.3 Beats per minute | Standard Deviation 10.37 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Erythrocytes | Day 7 | 0.189 Trillion cells per liter | Standard Deviation 0.1485 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Erythrocytes | Day 14 | 0.226 Trillion cells per liter | Standard Deviation 0.136 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Hematocrit | Day 7 | 0.0121 Proportion of red blood cells in blood | Standard Deviation 0.01389 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Hematocrit | Day 14 | 0.0189 Proportion of red blood cells in blood | Standard Deviation 0.01304 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Hemoglobin | Day 7 | 6.1 Grams per liter | Standard Deviation 4.51 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Hemoglobin | Day 14 | 8.4 Grams per liter | Standard Deviation 3.98 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) | Day 7 | 0.13 Picograms | Standard Deviation 0.272 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) | Day 14 | 0.36 Picograms | Standard Deviation 0.276 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) | Day 14 | -0.07 Femtoliters | Standard Deviation 0.712 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) | Day 7 | -0.83 Femtoliters | Standard Deviation 0.62 |
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.
Time frame: Baseline and at Days 7, and 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes, Period 1 Day 14 | -0.262 Giga cells per liter | Standard Deviation 0.4138 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelets, Period 1 Day 7 | 3.3 Giga cells per liter | Standard Deviation 21.23 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils, Period 1 Day 7 | -0.005 Giga cells per liter | Standard Deviation 0.0167 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils, Period 1 Day 14 | -0.006 Giga cells per liter | Standard Deviation 0.026 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils, Period 1 Day 7 | -0.021 Giga cells per liter | Standard Deviation 0.0795 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils, Period 1 Day 14 | -0.020 Giga cells per liter | Standard Deviation 0.1531 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes, Period 1 Day 7 | 0.014 Giga cells per liter | Standard Deviation 0.1808 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes, Period 1 Day 14 | 0.049 Giga cells per liter | Standard Deviation 0.2718 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Leukocytes, Period 1 Day 7 | -0.08 Giga cells per liter | Standard Deviation 1.795 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Leukocytes, Period 1 Day 14 | 0.27 Giga cells per liter | Standard Deviation 2.191 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes, Period 1 Day 7 | -0.246 Giga cells per liter | Standard Deviation 0.3089 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils, Period 1 Day 7 | 0.188 Giga cells per liter | Standard Deviation 1.5473 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils, Period 1 Day 14 | 0.513 Giga cells per liter | Standard Deviation 1.7986 |
| TAF/FTC | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelets, Period 1 Day 14 | 21.8 Giga cells per liter | Standard Deviation 35.37 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine | Day 7 | -0.34 pH | Standard Deviation 0.397 |
| TAF/FTC | Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine | Day 14 | -0.19 pH | Standard Deviation 0.544 |
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.
Time frame: Baseline and at Days 2, 3, 4, 5 and 7
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Pulse Rate | Day 4 | -4.0 Beats per minute | Standard Deviation 9.67 |
| TAF/FTC | Period 1: Change From Baseline in Pulse Rate | Day 5 | -1.6 Beats per minute | Standard Deviation 10.47 |
| TAF/FTC | Period 1: Change From Baseline in Pulse Rate | Day 7 | -7.6 Beats per minute | Standard Deviation 7.83 |
| TAF/FTC | Period 1: Change From Baseline in Pulse Rate | Day 2 | -1.2 Beats per minute | Standard Deviation 9.77 |
| TAF/FTC | Period 1: Change From Baseline in Pulse Rate | Day 3 | -3.8 Beats per minute | Standard Deviation 9.94 |
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.
Time frame: Baseline and at Days 2, 3, 4, 5 and 7
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Respiratory Rate | Day 2 | -1.5 Breaths per minute | Standard Deviation 2 |
| TAF/FTC | Period 1: Change From Baseline in Respiratory Rate | Day 3 | -0.5 Breaths per minute | Standard Deviation 3.14 |
| TAF/FTC | Period 1: Change From Baseline in Respiratory Rate | Day 4 | -0.5 Breaths per minute | Standard Deviation 2.37 |
| TAF/FTC | Period 1: Change From Baseline in Respiratory Rate | Day 5 | 1.3 Breaths per minute | Standard Deviation 2.52 |
| TAF/FTC | Period 1: Change From Baseline in Respiratory Rate | Day 7 | 0.6 Breaths per minute | Standard Deviation 3.24 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Specific Gravity of Urine | Day 7 | 0.0007 Ratio | Standard Deviation 0.01085 |
| TAF/FTC | Period 1: Change From Baseline in Specific Gravity of Urine | Day 14 | 0.0011 Ratio | Standard Deviation 0.00941 |
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.
Time frame: Baseline and at Days 2, 3, 4, 5 and 7
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Temperature | Day 2 | -0.16 Degree Celsius | Standard Deviation 0.4 |
| TAF/FTC | Period 1: Change From Baseline in Temperature | Day 3 | -0.15 Degree Celsius | Standard Deviation 0.576 |
| TAF/FTC | Period 1: Change From Baseline in Temperature | Day 4 | -0.09 Degree Celsius | Standard Deviation 0.406 |
| TAF/FTC | Period 1: Change From Baseline in Temperature | Day 5 | -0.15 Degree Celsius | Standard Deviation 0.371 |
| TAF/FTC | Period 1: Change From Baseline in Temperature | Day 7 | -0.24 Degree Celsius | Standard Deviation 0.491 |
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.
Time frame: Baseline and at Days 7, 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 1: Change From Baseline in Urine Urobilinogen | Day 7 | -2.5395 Micromoles per liter | Standard Deviation 5.45976 |
| TAF/FTC | Period 1: Change From Baseline in Urine Urobilinogen | Day 14 | -2.5395 Micromoles per liter | Standard Deviation 5.45976 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAF/FTC | Period 1: Tmax of FTC | 1.500 Hours |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAF/FTC | Period 1: Tmax of TAF | 1.00 Hours |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAF/FTC | Period 1: Tmax of TFV | 3.000 Hours |
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.
Time frame: Baseline and at Days 4, 7, 9, and 10
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of Blood Pressure | SBP, Baseline, n= 16 | 120.4 Millimeters of mercury | Standard Deviation 7.27 |
| TAF/FTC | Period 2: Absolute Values of Blood Pressure | SBP, Day 4, n=15 | 119.3 Millimeters of mercury | Standard Deviation 7.03 |
| TAF/FTC | Period 2: Absolute Values of Blood Pressure | SBP, Day 7, n=15 | 120.8 Millimeters of mercury | Standard Deviation 10.58 |
| TAF/FTC | Period 2: Absolute Values of Blood Pressure | SBP, Day 9, n=15 | 117.9 Millimeters of mercury | Standard Deviation 7.42 |
| TAF/FTC | Period 2: Absolute Values of Blood Pressure | SBP, Day 10, n=15 | 123.7 Millimeters of mercury | Standard Deviation 8.52 |
| TAF/FTC | Period 2: Absolute Values of Blood Pressure | DBP, Baseline, n= 16 | 74.4 Millimeters of mercury | Standard Deviation 6.14 |
| TAF/FTC | Period 2: Absolute Values of Blood Pressure | DBP, Day 4, n= 15 | 74.3 Millimeters of mercury | Standard Deviation 5.16 |
| TAF/FTC | Period 2: Absolute Values of Blood Pressure | DBP, Day 7, n= 15 | 77.9 Millimeters of mercury | Standard Deviation 8.98 |
| TAF/FTC | Period 2: Absolute Values of Blood Pressure | DBP, Day 9, n= 15 | 70.3 Millimeters of mercury | Standard Deviation 7.36 |
| TAF/FTC | Period 2: Absolute Values of Blood Pressure | DBP, Day 10, n= 15 | 72.1 Millimeters of mercury | Standard Deviation 6.41 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase | Amylase, Baseline, n= 16 | 53.6 Units per Liter | Standard Deviation 14.48 |
| TAF/FTC | Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase | Amylase, Day 3, n= 16 | 56.8 Units per Liter | Standard Deviation 19.32 |
| TAF/FTC | Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase | Amylase, Day 7, n= 15 | 52.7 Units per Liter | Standard Deviation 12.97 |
| TAF/FTC | Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase | Amylase, Day 9, n= 15 | 55.7 Units per Liter | Standard Deviation 13.39 |
| TAF/FTC | Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase | Lipase, Baseline, n= 16 | 16.9 Units per Liter | Standard Deviation 14.65 |
| TAF/FTC | Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase | Lipase, Day 3, n= 16 | 24.6 Units per Liter | Standard Deviation 34.82 |
| TAF/FTC | Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase | Lipase, Day 7, n= 15 | 17.5 Units per Liter | Standard Deviation 10.69 |
| TAF/FTC | Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase | Lipase, Day 9, n= 15 | 21.0 Units per Liter | Standard Deviation 14.16 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | GGT, Baseline, n= 16 | 2.40 International units per Liter | Standard Deviation 1.035 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | GGT, Day 3, n= 16 | 2.14 International units per Liter | Standard Deviation 1.065 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | GGT, Day 7, n= 15 | 2.41 International units per Liter | Standard Deviation 0.828 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | CK, Day 9, n= 15 | 122.2 International units per Liter | Standard Deviation 54.94 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Alkaline phosphatase, Baseline Day 3, n= 16 | 63.4 International units per Liter | Standard Deviation 8.82 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Alkaline phosphatase, Day 3, n= 16 | 67.1 International units per Liter | Standard Deviation 10.45 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Alkaline phosphatase, Day 7, n= 15 | 65.4 International units per Liter | Standard Deviation 9.81 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Alkaline phosphatase, Day 9, n= 15 | 61.8 International units per Liter | Standard Deviation 9.65 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | AST, Baseline, n= 16 | 17.6 International units per Liter | Standard Deviation 3.46 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | AST, Day 3, n= 16 | 16.2 International units per Liter | Standard Deviation 3.04 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | AST, Day 7, n= 15 | 17.2 International units per Liter | Standard Deviation 3.38 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | AST, Day 9, n= 15 | 17.6 International units per Liter | Standard Deviation 3.83 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | ALT, Baseline, n= 16 | 20.4 International units per Liter | Standard Deviation 8.59 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | ALT, Day 3, n= 16 | 18.4 International units per Liter | Standard Deviation 7.87 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | ALT, Day 7, n= 15 | 18.5 International units per Liter | Standard Deviation 8.31 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | ALT, Day 9, n= 15 | 19.7 International units per Liter | Standard Deviation 9.43 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | GGT, Day 9, n= 15 | 1.95 International units per Liter | Standard Deviation 0.673 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | LDH, Baseline, n= 16 | 126.0 International units per Liter | Standard Deviation 19.5 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | LDH, Day 3, n= 16 | 119.0 International units per Liter | Standard Deviation 19.37 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | LDH, Day 7, n= 15 | 118.0 International units per Liter | Standard Deviation 13.93 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | LDH, Day 9, n= 15 | 119.2 International units per Liter | Standard Deviation 17.7 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | CK, Baseline, n= 16 | 120.4 International units per Liter | Standard Deviation 62.41 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | CK, Day 3, n= 16 | 123.8 International units per Liter | Standard Deviation 51.53 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | CK, Day 7, n= 15 | 135.8 International units per Liter | Standard Deviation 66.33 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Glucose, Day 7, n= 15 | 5.129 Millimoles per Liter | Standard Deviation 0.3388 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Glucose, Day 9, n= 15 | 4.950 Millimoles per Liter | Standard Deviation 0.336 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Chloride, Day 9, n= 15 | 102.7 Millimoles per Liter | Standard Deviation 1.5 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Phosphate, Baseline, n= 16 | 1.103 Millimoles per Liter | Standard Deviation 0.0807 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Triglycerides, Day 7, n= 15 | 1.120 Millimoles per Liter | Standard Deviation 0.4358 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Triglycerides, Day 9, n= 15 | 0.961 Millimoles per Liter | Standard Deviation 0.432 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | BUN, Baseline, n= 16 | 4.246 Millimoles per Liter | Standard Deviation 0.782 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | BUN, Day 7, n= 15 | 4.260 Millimoles per Liter | Standard Deviation 0.8705 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | BUN Day 9, n= 15 | 4.263 Millimoles per Liter | Standard Deviation 0.6977 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Glucose, Baseline, n= 16 | 4.791 Millimoles per Liter | Standard Deviation 0.2662 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Glucose, Day 3, n= 15 | 5.027 Millimoles per Liter | Standard Deviation 0.2894 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Cholesterol, Baseline, n= 16 | 3.864 Millimoles per Liter | Standard Deviation 0.6087 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Cholesterol, Day 3, n=15 | 3.875 Millimoles per Liter | Standard Deviation 0.6509 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Cholesterol, Day 7, n= 15 | 3.894 Millimoles per Liter | Standard Deviation 0.7575 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Cholesterol, Day 9, n= 16 | 3.822 Millimoles per Liter | Standard Deviation 0.7838 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Anion gap, Baseline, n= 16 | 10.9 Millimoles per Liter | Standard Deviation 1.45 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Anion gap, Day 3, n= 16 | 10.5 Millimoles per Liter | Standard Deviation 1.37 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Anion gap, Day 7, n= 15 | 10.3 Millimoles per Liter | Standard Deviation 1.28 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Anion gap, Day 9, n= 15 | 10.5 Millimoles per Liter | Standard Deviation 0.74 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Calcium, Baseline, n= 16 | 2.387 Millimoles per Liter | Standard Deviation 0.0637 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Calcium, Day 3, n= 16 | 2.399 Millimoles per Liter | Standard Deviation 0.0682 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Calcium, Day 7, n= 15 | 2.424 Millimoles per Liter | Standard Deviation 0.0693 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Calcium, Day 9, n= 15 | 2.421 Millimoles per Liter | Standard Deviation 0.067 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | CO2, Baseline, n= 16 | 30.8 Millimoles per Liter | Standard Deviation 1.38 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | CO2, Day 3, n= 16 | 30.3 Millimoles per Liter | Standard Deviation 1.96 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | CO2, Day 7, n= 15 | 30.7 Millimoles per Liter | Standard Deviation 1.91 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | CO2, Day 9, n= 15 | 30.5 Millimoles per Liter | Standard Deviation 1.3 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Chloride, Baseline, n= 16 | 101.3 Millimoles per Liter | Standard Deviation 2.32 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Chloride, Day 3, n= 16 | 103.6 Millimoles per Liter | Standard Deviation 1.5 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Chloride, Day 7, n= 15 | 101.9 Millimoles per Liter | Standard Deviation 1.62 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Phosphate, Day 3, n= 16 | 1.165 Millimoles per Liter | Standard Deviation 0.1007 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Phosphate, Day 7, n= 15 | 1.112 Millimoles per Liter | Standard Deviation 0.1097 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Phosphate, Day 9, n= 15 | 1.117 Millimoles per Liter | Standard Deviation 0.0952 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Potassium, Baseline, n= 16 | 4.22 Millimoles per Liter | Standard Deviation 0.279 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Potassium, Day 3, n= 16 | 4.23 Millimoles per Liter | Standard Deviation 0.241 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Potassium, Day 7, n= 15 | 4.21 Millimoles per Liter | Standard Deviation 0.236 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Potassium, Day 9, n= 15 | 4.35 Millimoles per Liter | Standard Deviation 0.226 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Sodium, Baseline, n= 16 | 138.8 Millimoles per Liter | Standard Deviation 1.69 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Sodium, Day 3, n= 16 | 140.2 Millimoles per Liter | Standard Deviation 1.56 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Sodium, Day 7, n= 15 | 138.8 Millimoles per Liter | Standard Deviation 1.42 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Sodium, Day 9, n=15 | 139.3 Millimoles per Liter | Standard Deviation 1.18 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Triglycerides, Baseline, n= 16 | 1.033 Millimoles per Liter | Standard Deviation 0.3034 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Triglycerides, Day 3, n= 16 | 1.029 Millimoles per Liter | Standard Deviation 0.344 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | BUN, Day 3, n= 16 | 4.558 Millimoles per Liter | Standard Deviation 0.8267 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Total bilirubin, Day 3, n= 16 | 10.62 Micromoles per liter | Standard Deviation 7.886 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Total bilirubin, Day 7, n= 15 | 11.33 Micromoles per liter | Standard Deviation 5.487 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Total bilirubin, Day 9, n= 15 | 9.68 Micromoles per liter | Standard Deviation 4.603 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Creatinine, Baseline, n= 16 | 87.52 Micromoles per liter | Standard Deviation 10.058 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Creatinine, Day 3, n= 16 | 85.18 Micromoles per liter | Standard Deviation 10.314 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Creatinine, Day 7, n= 15 | 91.53 Micromoles per liter | Standard Deviation 9.504 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Creatinine, Day 9, n= 15 | 88.27 Micromoles per liter | Standard Deviation 9.916 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Total bilirubin, Baseline, n= 16 | 11.44 Micromoles per liter | Standard Deviation 6.022 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Direct bilirubin, Baseline, n= 16 | 2.40 Micromoles per liter | Standard Deviation 1.035 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Direct bilirubin, Day 3, n= 16 | 2.14 Micromoles per liter | Standard Deviation 1.065 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Direct bilirubin, Day 7, n= 15 | 2.41 Micromoles per liter | Standard Deviation 0.828 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Direct bilirubin, Day 9, n= 15 | 1.95 Micromoles per liter | Standard Deviation 0.673 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Total Protein, Baseline, n= 16 | 72.6 Grams per Liter | Standard Deviation 3.1 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Albumin, Baseline, n= 16 | 43.9 Grams per Liter | Standard Deviation 2.41 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Total Protein, Day 3, n= 16 | 72.8 Grams per Liter | Standard Deviation 2.96 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Total Protein, Day 7, n= 15 | 75.7 Grams per Liter | Standard Deviation 2.89 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Total Protein, Day 9, n= 15 | 73.3 Grams per Liter | Standard Deviation 2.61 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Globulin, Baseline, n= 16 | 28.7 Grams per Liter | Standard Deviation 1.99 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Globulin, Day 3, n= 16 | 28.9 Grams per Liter | Standard Deviation 2.31 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Globulin, Day 7, n= 15 | 30.9 Grams per Liter | Standard Deviation 1.96 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Globulin, Day 9, n= 15 | 28.8 Grams per Liter | Standard Deviation 1.9 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Albumin, Day 3, n= 16 | 43.9 Grams per Liter | Standard Deviation 1.89 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Albumin, Day 7, n= 15 | 44.8 Grams per Liter | Standard Deviation 2.08 |
| TAF/FTC | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Albumin, Day 9, n= 15 | 44.5 Grams per Liter | Standard Deviation 1.73 |
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.
Time frame: 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
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 4, Pre-dose, n= 15 | 167.1 Milliseconds | Standard Deviation 22.2 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 4, 2 hours post-dose, n= 15 | 160.7 Milliseconds | Standard Deviation 19.59 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 7, Pre-dose, n= 15 | 94.5 Milliseconds | Standard Deviation 8.25 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 7, 2 hours post-dose, n= 15 | 92.7 Milliseconds | Standard Deviation 7.49 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 1, 4 hours post-dose, n= 16 | 375.9 Milliseconds | Standard Deviation 30.14 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 1, 4 hours post-dose, n= 16 | 400.4 Milliseconds | Standard Deviation 16.2 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 9 post-dose, n= 15 | 404.0 Milliseconds | Standard Deviation 20.62 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Baseline, n= 16 | 167.3 Milliseconds | Standard Deviation 19.46 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 1, 2 hours post-dose, n= 16 | 160.4 Milliseconds | Standard Deviation 19.73 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 1, 4 hours post-dose, n= 16 | 163.6 Milliseconds | Standard Deviation 19.04 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 4, 4 hours post-dose, n= 15 | 163.7 Milliseconds | Standard Deviation 19.29 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 7, Pre-dose, n= 15 | 164.9 Milliseconds | Standard Deviation 21.11 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 7, 2 hours post-dose, n= 15 | 164.3 Milliseconds | Standard Deviation 20.95 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 7, 4 hours post-dose, n= 15 | 163.9 Milliseconds | Standard Deviation 22.05 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 9 post-dose, n= 15 | 168.8 Milliseconds | Standard Deviation 23.7 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Baseline, n= 16 | 91.4 Milliseconds | Standard Deviation 7.87 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 1, 2 hours post-dose, n= 16 | 88.9 Milliseconds | Standard Deviation 8.2 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 1, 4 hours post-dose, n= 16 | 90.1 Milliseconds | Standard Deviation 7.66 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 4, Pre-dose, n= 15 | 91.8 Milliseconds | Standard Deviation 8.37 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 4, 2 hours post-dose, n= 15 | 91.8 Milliseconds | Standard Deviation 9.12 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 4, 4 hours post-dose, n= 15 | 91.1 Milliseconds | Standard Deviation 8.51 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 7, 4 hours post-dose, n= 15 | 91.6 Milliseconds | Standard Deviation 7.23 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 9 post-dose, n= 15 | 94.3 Milliseconds | Standard Deviation 8.17 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Baseline, n= 16 | 377.7 Milliseconds | Standard Deviation 22.66 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 1, 2 hours post-dose, n= 16 | 365.1 Milliseconds | Standard Deviation 23.71 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 4, Pre-dose, n= 15 | 385.6 Milliseconds | Standard Deviation 26.65 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 4, 2 hours post-dose, n= 15 | 371.5 Milliseconds | Standard Deviation 27.31 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 4, 4 hours post-dose, n= 15 | 383.9 Milliseconds | Standard Deviation 31.05 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 7, Pre-dose, n= 15 | 381.7 Milliseconds | Standard Deviation 22.25 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 7, 2 hours post-dose, n= 15 | 369.9 Milliseconds | Standard Deviation 25.66 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 7, 4 hours post-dose, n= 15 | 384.1 Milliseconds | Standard Deviation 30.53 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 9 post-dose, n= 15 | 382.4 Milliseconds | Standard Deviation 26.55 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Baseline, n= 16 | 390.0 Milliseconds | Standard Deviation 13.48 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 1, 2 hours, n= 16 | 385.6 Milliseconds | Standard Deviation 15.44 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 1, 4 hours post-dose, n= 16 | 392.4 Milliseconds | Standard Deviation 15.95 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 4, Pre-dose, n= 15 | 395.0 Milliseconds | Standard Deviation 21.88 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 4, 2 hours post-dose, n= 15 | 388.3 Milliseconds | Standard Deviation 17.56 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 4, 4 hours post-dose, n= 15 | 393.4 Milliseconds | Standard Deviation 18.97 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 7, Pre-dose, n= 15 | 393.0 Milliseconds | Standard Deviation 18.42 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 7, 2 hours post-dose, n= 15 | 383.8 Milliseconds | Standard Deviation 16.19 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 7, 4 hours post-dose, n= 15 | 389.5 Milliseconds | Standard Deviation 18.06 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 9 post-dose, n= 15 | 396.8 Milliseconds | Standard Deviation 18.51 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Baseline, n= 16 | 395.7 Milliseconds | Standard Deviation 14.19 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 1, 2 hours post-dose, n= 16 | 396.4 Milliseconds | Standard Deviation 17.29 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 4, Pre-dose, n= 15 | 399.2 Milliseconds | Standard Deviation 25.96 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 4, 2 hours post-dose, n= 15 | 396.2 Milliseconds | Standard Deviation 16.01 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 4, 4 hours post-dose, n= 15 | 398.0 Milliseconds | Standard Deviation 17.53 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 7, Pre-dose, n= 15 | 398.3 Milliseconds | Standard Deviation 23.83 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 7, 2 hours post-dose, n= 15 | 390.5 Milliseconds | Standard Deviation 13.31 |
| TAF/FTC | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 7, 4 hours post-dose, n= 15 | 391.9 Milliseconds | Standard Deviation 16.35 |
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.
Time frame: 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
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of Heart Rate | Day 1, 2 hours post-dose, n= 16 | 71.5 Beats per minute | Standard Deviation 9.95 |
| TAF/FTC | Period 2: Absolute Values of Heart Rate | Day 1, 4 hours post-dose, n= 16 | 69.3 Beats per minute | Standard Deviation 11.38 |
| TAF/FTC | Period 2: Absolute Values of Heart Rate | Day 4, Pre-dose, n= 15 | 65.1 Beats per minute | Standard Deviation 10.48 |
| TAF/FTC | Period 2: Absolute Values of Heart Rate | Baseline, n= 16 | 66.5 Beats per minute | Standard Deviation 8.06 |
| TAF/FTC | Period 2: Absolute Values of Heart Rate | Day 4, 2 hours post-dose, n= 15 | 68.9 Beats per minute | Standard Deviation 8 |
| TAF/FTC | Period 2: Absolute Values of Heart Rate | Day 4, 4 hours post-dose, n= 15 | 65.3 Beats per minute | Standard Deviation 8.97 |
| TAF/FTC | Period 2: Absolute Values of Heart Rate | Day 7, Pre-dose, n= 15 | 65.9 Beats per minute | Standard Deviation 10.25 |
| TAF/FTC | Period 2: Absolute Values of Heart Rate | Day 7, 2 hours post-dose, n= 15 | 67.4 Beats per minute | Standard Deviation 6.39 |
| TAF/FTC | Period 2: Absolute Values of Heart Rate | Day 7, 4 hours post-dose, n= 15 | 63.3 Beats per minute | Standard Deviation 8.31 |
| TAF/FTC | Period 2: Absolute Values of Heart Rate | Day 9 post-dose, n= 15 | 67.7 Beats per minute | Standard Deviation 9.23 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of pH of Urine | Baseline, n= 16 | 6.03 pH | Standard Deviation 0.531 |
| TAF/FTC | Period 2: Absolute Values of pH of Urine | Day 3, n= 16 | 6.22 pH | Standard Deviation 0.482 |
| TAF/FTC | Period 2: Absolute Values of pH of Urine | Day 7, n= 15 | 6.07 pH | Standard Deviation 0.32 |
| TAF/FTC | Period 2: Absolute Values of pH of Urine | Day 9, n= 15 | 6.07 pH | Standard Deviation 0.32 |
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.
Time frame: Baseline and at Days 4, 7, 9, and 10
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of Pulse Rate | Baseline, n= 16 | 70.5 Beats per minute | Standard Deviation 11.33 |
| TAF/FTC | Period 2: Absolute Values of Pulse Rate | Day 4, n=15 | 71.9 Beats per minute | Standard Deviation 18.39 |
| TAF/FTC | Period 2: Absolute Values of Pulse Rate | Day 7, n=15 | 71.4 Beats per minute | Standard Deviation 14.73 |
| TAF/FTC | Period 2: Absolute Values of Pulse Rate | Day 9, n=15 | 69.2 Beats per minute | Standard Deviation 10.73 |
| TAF/FTC | Period 2: Absolute Values of Pulse Rate | Day 10, n=15 | 79.0 Beats per minute | Standard Deviation 12.45 |
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.
Time frame: Baseline and at Days 4, 7, 9, and 10
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of Respiratory Rate | Baseline, n= 16 | 15.6 Breaths per minute | Standard Deviation 2.22 |
| TAF/FTC | Period 2: Absolute Values of Respiratory Rate | Day 4, n=15 | 12.5 Breaths per minute | Standard Deviation 2.67 |
| TAF/FTC | Period 2: Absolute Values of Respiratory Rate | Day 7, n=15 | 13.3 Breaths per minute | Standard Deviation 2.35 |
| TAF/FTC | Period 2: Absolute Values of Respiratory Rate | Day 9, n=15 | 14.9 Breaths per minute | Standard Deviation 1.49 |
| TAF/FTC | Period 2: Absolute Values of Respiratory Rate | Day 10, n=15 | 14.3 Breaths per minute | Standard Deviation 1.49 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of Specific Gravity of Urine | Baseline, n= 16 | 1.0147 Ratio | Standard Deviation 0.00789 |
| TAF/FTC | Period 2: Absolute Values of Specific Gravity of Urine | Day 3, n= 16 | 1.0178 Ratio | Standard Deviation 0.00584 |
| TAF/FTC | Period 2: Absolute Values of Specific Gravity of Urine | Day 7, n= 15 | 1.0170 Ratio | Standard Deviation 0.00655 |
| TAF/FTC | Period 2: Absolute Values of Specific Gravity of Urine | Day 9, n= 15 | 1.0151 Ratio | Standard Deviation 0.00788 |
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.
Time frame: Baseline and at Days 4, 7, 9, and 10
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of Temperature | Baseline, n= 16 | 36.49 Degree Celsius | Standard Deviation 0.257 |
| TAF/FTC | Period 2: Absolute Values of Temperature | Day 4, n=15 | 36.37 Degree Celsius | Standard Deviation 0.348 |
| TAF/FTC | Period 2: Absolute Values of Temperature | Day 7, n=15 | 36.40 Degree Celsius | Standard Deviation 0.421 |
| TAF/FTC | Period 2: Absolute Values of Temperature | Day 9, n=15 | 36.46 Degree Celsius | Standard Deviation 0.378 |
| TAF/FTC | Period 2: Absolute Values of Temperature | Day 10, n=15 | 36.53 Degree Celsius | Standard Deviation 0.282 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: Erythrocytes | Day 9, n= 15 | 5.001 Trillion cells per liter | Standard Deviation 0.3446 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: Erythrocytes | Baseline, n= 16 | 5.203 Trillion cells per liter | Standard Deviation 0.3604 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: Erythrocytes | Day 3, n= 16 | 5.090 Trillion cells per liter | Standard Deviation 0.3395 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: Erythrocytes | Day 7, n= 15 | 5.190 Trillion cells per liter | Standard Deviation 0.4087 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: Hematocrit | Baseline, n= 16 | 0.4453 Proportion of red blood cells in blood | Standard Deviation 0.01997 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: Hematocrit | Day 3, n= 16 | 0.4306 Proportion of red blood cells in blood | Standard Deviation 0.0178 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: Hematocrit | Day 7, n= 15 | 0.4444 Proportion of red blood cells in blood | Standard Deviation 0.02234 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: Hematocrit | Day 9, n= 15 | 0.4247 Proportion of red blood cells in blood | Standard Deviation 0.01518 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: Hemoglobin | Baseline, n= 16 | 150.4 Grams per liter | Standard Deviation 7.45 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: Hemoglobin | Day 3, n= 16 | 146.4 Grams per liter | Standard Deviation 6.37 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: Hemoglobin | Day 7, n= 15 | 149.1 Grams per liter | Standard Deviation 7.26 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: Hemoglobin | Day 9, n= 15 | 143.9 Grams per liter | Standard Deviation 5.19 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: MCH | Baseline, n= 16 | 28.98 Picograms | Standard Deviation 1.69 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: MCH | Day 3, n= 16 | 28.88 Picograms | Standard Deviation 1.699 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: MCH | Day 7, n= 15 | 28.83 Picograms | Standard Deviation 1.63 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: MCH | Day 9, n= 15 | 28.87 Picograms | Standard Deviation 1.702 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: MCV | Baseline, n= 16 | 85.85 Femtoliters | Standard Deviation 4.492 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: MCV | Day 3, n= 16 | 84.83 Femtoliters | Standard Deviation 4.49 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: MCV | Day 7, n= 15 | 85.85 Femtoliters | Standard Deviation 4.491 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter: MCV | Day 9, n= 15 | 85.20 Femtoliters | Standard Deviation 4.601 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils, Period 2 Baseline, n= 16 | 0.040 Giga cells per liter | Standard Deviation 0.0256 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils, Period 2 Day 3, n= 15 | 0.036 Giga cells per liter | Standard Deviation 0.0182 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils, Period 2 Day 7, n= 15 | 0.038 Giga cells per liter | Standard Deviation 0.0152 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils, Period 2 Day 9, n= 15 | 0.043 Giga cells per liter | Standard Deviation 0.0232 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils, Period 2 Baseline, n= 16 | 0.208 Giga cells per liter | Standard Deviation 0.1764 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils, Period 2 Day 3, n= 15 | 0.185 Giga cells per liter | Standard Deviation 0.1533 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils, Period 2 Day 7, n= 15 | 0.157 Giga cells per liter | Standard Deviation 0.1405 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes, Period 2 Day 3, n= 16 | 0.492 Giga cells per liter | Standard Deviation 0.1975 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Leukocytes, Period 2 Day 7, n= 15 | 5.39 Giga cells per liter | Standard Deviation 1.311 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Leukocytes, Period 2 Day 9, n= 15 | 5.51 Giga cells per liter | Standard Deviation 1.415 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes, Period 2 Day 7, n= 15 | 1.570 Giga cells per liter | Standard Deviation 0.4116 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes, Period 2 Day 9, n= 15 | 1.563 Giga cells per liter | Standard Deviation 0.4236 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelets, Period 2 Baseline, n= 16 | 274.3 Giga cells per liter | Standard Deviation 51.1 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelets, Period 2 Day 3, n= 16 | 283.4 Giga cells per liter | Standard Deviation 54.62 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils, Period 2 Day 9, n= 16 | 0.153 Giga cells per liter | Standard Deviation 0.1384 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes, Period 2 Baseline, n= 16 | 0.545 Giga cells per liter | Standard Deviation 0.2127 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes, Period 2 Day 7, n= 15 | 0.448 Giga cells per liter | Standard Deviation 0.1472 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes, Period 2 Day 9, n= 15 | 0.421 Giga cells per liter | Standard Deviation 0.1212 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Leukocytes, Period 2 Baseline, n= 16 | 6.20 Giga cells per liter | Standard Deviation 1.752 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Leukocytes, Period 2 Day 3, n= 16 | 5.14 Giga cells per liter | Standard Deviation 1.035 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes, Period 2 Baseline, n= 16 | 1.718 Giga cells per liter | Standard Deviation 0.4814 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes, Period 2 Day 3, n= 16 | 1.560 Giga cells per liter | Standard Deviation 0.3786 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils, Period 2 Baseline, n= 16 | 3.724 Giga cells per liter | Standard Deviation 1.3787 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils, Period 2 Day 3, n= 16 | 2.857 Giga cells per liter | Standard Deviation 0.8106 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils, Period 2 Day 7, n= 15 | 3.189 Giga cells per liter | Standard Deviation 1.0515 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils, Period 2 Day 9, n= 15 | 3.324 Giga cells per liter | Standard Deviation 1.1988 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelets, Period 2 Day 7, n= 15 | 294.0 Giga cells per liter | Standard Deviation 54.62 |
| TAF/FTC | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelets, Period 2 Day 9, n= 15 | 290.4 Giga cells per liter | Standard Deviation 73.92 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Absolute Values of Urine Urobilinogen | Baseline, n= 16 | 3.3860 Micromoles per liter | Standard Deviation 0 |
| TAF/FTC | Period 2: Absolute Values of Urine Urobilinogen | Day 3, n= 16 | 3.3860 Micromoles per liter | Standard Deviation 0 |
| TAF/FTC | Period 2: Absolute Values of Urine Urobilinogen | Day 7, n= 15 | 3.3860 Micromoles per liter | Standard Deviation 0 |
| TAF/FTC | Period 2: Absolute Values of Urine Urobilinogen | Day 9, n= 15 | 3.3860 Micromoles per liter | Standard Deviation 0 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 2: AUC (0-tau) of GSK3640254 | 24.53 Hours*nanogram per milliliter | Geometric Coefficient of Variation 26.5 |
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.
Time frame: Baseline and at Days 4, 7, 9, and 10
Population: Safety Population. Only those participants with data available at the specified time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Blood Pressure | SBP, Day 9 | -1.7 Millimeters of mercury | Standard Deviation 6.91 |
| TAF/FTC | Period 2: Change From Baseline in Blood Pressure | SBP, Day 10 | 4.1 Millimeters of mercury | Standard Deviation 7.79 |
| TAF/FTC | Period 2: Change From Baseline in Blood Pressure | SBP, Day 4 | -0.3 Millimeters of mercury | Standard Deviation 5.07 |
| TAF/FTC | Period 2: Change From Baseline in Blood Pressure | SBP, Day 7 | 1.1 Millimeters of mercury | Standard Deviation 8.95 |
| TAF/FTC | Period 2: Change From Baseline in Blood Pressure | DBP, Day 4 | 0.1 Millimeters of mercury | Standard Deviation 4.96 |
| TAF/FTC | Period 2: Change From Baseline in Blood Pressure | DBP, Day 7 | 3.7 Millimeters of mercury | Standard Deviation 5.7 |
| TAF/FTC | Period 2: Change From Baseline in Blood Pressure | DBP, Day 9 | -4.0 Millimeters of mercury | Standard Deviation 5.26 |
| TAF/FTC | Period 2: Change From Baseline in Blood Pressure | DBP, Day 10 | -2.1 Millimeters of mercury | Standard Deviation 8.18 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Alkaline phosphatase, Day 3, n= 16 | 3.7 International units per Liter | Standard Deviation 3.48 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Alkaline phosphatase, Day 7, n= 15 | 2.6 International units per Liter | Standard Deviation 3.64 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | Alkaline phosphatase, Day 9, n= 15 | -1.0 International units per Liter | Standard Deviation 3.98 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | AST, Day 3, n= 16 | -1.4 International units per Liter | Standard Deviation 1.31 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | AST, Day 7, n= 15 | -0.5 International units per Liter | Standard Deviation 2.45 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | AST, Day 9, n= 15 | -0.1 International units per Liter | Standard Deviation 2.13 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | ALT, Day 3, n= 16 | -2.0 International units per Liter | Standard Deviation 1.63 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | ALT, Day 7, n= 15 | -1.9 International units per Liter | Standard Deviation 2.76 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | ALT, Day 9, n= 15 | -0.7 International units per Liter | Standard Deviation 4.56 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | GGT, Day 3, n= 16 | -0.9 International units per Liter | Standard Deviation 1.18 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | GGT, Day 7, n= 15 | -1.4 International units per Liter | Standard Deviation 1.5 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | GGT, Day 9, n= 15 | -1.9 International units per Liter | Standard Deviation 2.55 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | LDH, Day 3, n= 16 | -7.0 International units per Liter | Standard Deviation 11.98 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | LDH, Day 7, n= 15 | -8.2 International units per Liter | Standard Deviation 12.73 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | LDH, Day 9, n= 15 | -7.0 International units per Liter | Standard Deviation 11.98 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | CK, Day 3, n= 16 | 3.4 International units per Liter | Standard Deviation 29.12 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | CK, Day 7, n= 15 | 11.3 International units per Liter | Standard Deviation 33.83 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK | CK, Day 9, n= 15 | -2.3 International units per Liter | Standard Deviation 22.65 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Glucose, Day 9, n= 15 | 0.136 Millimoles per Liter | Standard Deviation 0.2433 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Cholesterol, Day 3, n=15 | 0.011 Millimoles per Liter | Standard Deviation 0.2372 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Cholesterol, Day 9, n= 16 | 0.030 Millimoles per Liter | Standard Deviation 0.4594 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Calcium, Day 3, n= 16 | 0.013 Millimoles per Liter | Standard Deviation 0.0478 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Calcium, Day 9, n= 15 | 0.033 Millimoles per Liter | Standard Deviation 0.0628 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Potassium, Day 3, n= 16 | 0.01 Millimoles per Liter | Standard Deviation 0.284 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Triglycerides, Day 9, n= 15 | -0.049 Millimoles per Liter | Standard Deviation 0.2747 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Glucose, Day 3, n= 15 | 0.236 Millimoles per Liter | Standard Deviation 0.2463 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Glucose, Day 7, n= 15 | 0.315 Millimoles per Liter | Standard Deviation 0.3282 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Cholesterol, Day 7, n= 15 | 0.102 Millimoles per Liter | Standard Deviation 0.3899 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Anion gap, Day 3, n= 16 | -0.4 Millimoles per Liter | Standard Deviation 1.82 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Anion gap, Day 7, n= 15 | -0.5 Millimoles per Liter | Standard Deviation 1.73 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Anion gap, Day 9, n= 15 | -0.3 Millimoles per Liter | Standard Deviation 1.67 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Calcium, Day 7, n= 15 | 0.037 Millimoles per Liter | Standard Deviation 0.0568 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | CO2, Day 3, n= 16 | -0.5 Millimoles per Liter | Standard Deviation 1.26 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | CO2, Day 7, n= 15 | -0.1 Millimoles per Liter | Standard Deviation 1.36 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | CO2, Day 9, n= 15 | -0.4 Millimoles per Liter | Standard Deviation 1.18 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Chloride, Day 3, n= 16 | 2.3 Millimoles per Liter | Standard Deviation 1.2 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Chloride, Day 7, n= 15 | 0.6 Millimoles per Liter | Standard Deviation 1.35 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Chloride, Day 9, n= 15 | 1.3 Millimoles per Liter | Standard Deviation 1.72 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Phosphate, Day 3, n= 16 | 0.062 Millimoles per Liter | Standard Deviation 0.0683 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Phosphate, Day 7, n= 15 | 0.002 Millimoles per Liter | Standard Deviation 0.08 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Phosphate, Day 9, n= 15 | 0.007 Millimoles per Liter | Standard Deviation 0.0584 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Potassium, Day 7, n= 15 | -0.03 Millimoles per Liter | Standard Deviation 0.213 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Potassium, Day 9, n= 15 | 0.10 Millimoles per Liter | Standard Deviation 0.344 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Sodium, Day 3, n= 16 | 1.4 Millimoles per Liter | Standard Deviation 1.36 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Sodium, Day 7, n= 15 | 0.1 Millimoles per Liter | Standard Deviation 1.53 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Sodium, Day 9, n= 15 | 0.6 Millimoles per Liter | Standard Deviation 1.06 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Triglycerides, Day 3, n= 16 | -0.003 Millimoles per Liter | Standard Deviation 0.1753 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | Triglycerides, Day 7, n= 15 | 0.111 Millimoles per Liter | Standard Deviation 0.2414 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | BUN, Day 3, n= 16 | 0.312 Millimoles per Liter | Standard Deviation 0.5567 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | BUN, Day 7, n= 15 | -0.031 Millimoles per Liter | Standard Deviation 0.5038 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus | BUN, Day 9, n= 15 | -0.028 Millimoles per Liter | Standard Deviation 0.4521 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Amylase, Day 3, n= 16 | 3.3 Units per Liter | Standard Deviation 8.93 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Amylase, Day 7, n= 15 | -1.9 Units per Liter | Standard Deviation 6.77 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Amylase, Day 9, n= 15 | 1.1 Units per Liter | Standard Deviation 6.32 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Lipase, Day 3, n= 16 | 7.7 Units per Liter | Standard Deviation 21.62 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Lipase, Day 7, n= 15 | 0.0 Units per Liter | Standard Deviation 8.2 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase | Lipase, Day 9, n= 15 | 3.5 Units per Liter | Standard Deviation 3.89 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Creatinine, Day 3, n= 16 | -2.34 Micromoles per liter | Standard Deviation 3.755 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Creatinine, Day 7, n= 15 | 3.53 Micromoles per liter | Standard Deviation 3.802 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Creatinine, Day 9, n= 15 | 0.28 Micromoles per liter | Standard Deviation 3.569 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Total bilirubin, Day 3, n= 16 | -0.82 Micromoles per liter | Standard Deviation 3.475 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Total bilirubin, Day 7, n= 15 | -0.26 Micromoles per liter | Standard Deviation 2.466 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Total bilirubin, Day 9, n= 15 | -1.91 Micromoles per liter | Standard Deviation 2.252 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Direct bilirubin, Day 3, n= 16 | -0.26 Micromoles per liter | Standard Deviation 0.534 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Direct bilirubin, Day 7, n= 15 | -0.03 Micromoles per liter | Standard Deviation 0.547 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine | Direct bilirubin, Day 9, n= 15 | -0.49 Micromoles per liter | Standard Deviation 0.501 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Total Protein, Day 3, n= 16 | 0.1 Grams per Liter | Standard Deviation 2.68 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Total Protein, Day 7, n= 15 | 3.1 Grams per Liter | Standard Deviation 2.85 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Total Protein, Day 9, n= 15 | 0.8 Grams per Liter | Standard Deviation 3.28 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Globulin, Day 3, n= 16 | 0.2 Grams per Liter | Standard Deviation 1.17 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Globulin, Day 7, n= 15 | 2.3 Grams per Liter | Standard Deviation 0.96 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Globulin, Day 9, n= 15 | 0.2 Grams per Liter | Standard Deviation 1.08 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Albumin, Day 3, n= 16 | -0.1 Grams per Liter | Standard Deviation 1.95 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Albumin, Day 7, n= 15 | 0.9 Grams per Liter | Standard Deviation 2.2 |
| TAF/FTC | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin | Albumin, Day 9, n= 15 | 0.6 Grams per Liter | Standard Deviation 2.5 |
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.
Time frame: 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
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 4, 4 hours post-dose, n= 15 | -0.2 Milliseconds | Standard Deviation 2.7 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 1, 4 hours post-dose, n= 16 | 2.4 Milliseconds | Standard Deviation 7.77 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 4, Pre-dose, n= 15 | 6.1 Milliseconds | Standard Deviation 11.17 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 1, 2 hours post-dose, n= 16 | 0.7 Milliseconds | Standard Deviation 8.83 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 7, 2 hours post-dose, n= 15 | -3.2 Milliseconds | Standard Deviation 11.64 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 1, 2 hours post-dose, n= 16 | -6.8 Milliseconds | Standard Deviation 6.77 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 1, 4 hours post-dose, n= 16 | -3.7 Milliseconds | Standard Deviation 5.99 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 4, Pre-dose, n= 15 | -0.5 Milliseconds | Standard Deviation 4.56 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 4, 2 hours post-dose, n= 15 | -6.9 Milliseconds | Standard Deviation 6.67 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 4, 4 hours post-dose, n= 15 | -3.9 Milliseconds | Standard Deviation 7.83 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 7, Pre-dose, n= 15 | -2.7 Milliseconds | Standard Deviation 8.57 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 7, 2 hours post-dose, n= 15 | -3.3 Milliseconds | Standard Deviation 7.06 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 7, 4 hours post-dose, n= 15 | -3.7 Milliseconds | Standard Deviation 8.53 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR Interval, Day 9 post-dose, n= 15 | 1.2 Milliseconds | Standard Deviation 6.42 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 1, 2 hours post-dose, n= 16 | -2.5 Milliseconds | Standard Deviation 4.4 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 1, 4 hours post-dose, n= 16 | -1.4 Milliseconds | Standard Deviation 4.69 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 4, Pre-dose, n= 15 | 0.5 Milliseconds | Standard Deviation 3.44 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 4, 2 hours post-dose, n= 15 | 0.5 Milliseconds | Standard Deviation 5.72 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 7, Pre-dose, n= 15 | 3.3 Milliseconds | Standard Deviation 4.53 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 7, 2 hours post-dose, n= 15 | 1.5 Milliseconds | Standard Deviation 5.15 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 7, 4 hours post-dose, n= 15 | 0.3 Milliseconds | Standard Deviation 3.72 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS Duration, Day 9 post-dose, n= 15 | 3.0 Milliseconds | Standard Deviation 5.36 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 1, 2 hours post-dose, n= 16 | -12.6 Milliseconds | Standard Deviation 9.11 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 1, 4 hours post-dose, n= 16 | -1.8 Milliseconds | Standard Deviation 14.72 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 4, Pre-dose, n= 15 | 7.3 Milliseconds | Standard Deviation 18.27 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 4, 2 hours post-dose, n= 15 | -6.8 Milliseconds | Standard Deviation 15.72 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 4, 4 hours post-dose, n= 15 | 5.6 Milliseconds | Standard Deviation 14.64 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 7, Pre-dose, n= 15 | 3.5 Milliseconds | Standard Deviation 18.31 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 7, 2 hours post-dose, n= 15 | -8.4 Milliseconds | Standard Deviation 16.15 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 7, 4 hours post-dose, n= 15 | 5.8 Milliseconds | Standard Deviation 17.37 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT Interval, Day 9 post-dose, n= 15 | 4.1 Milliseconds | Standard Deviation 16.46 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 1, 2 hours post-dose, n= 16 | -4.4 Milliseconds | Standard Deviation 7.29 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 4, 2 hours post-dose, n= 15 | -0.6 Milliseconds | Standard Deviation 10.91 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 4, 4 hours post-dose, n= 15 | 4.5 Milliseconds | Standard Deviation 8.22 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 7, Pre-dose, n= 15 | 4.1 Milliseconds | Standard Deviation 8.71 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 7, 2 hours post-dose, n= 15 | -5.1 Milliseconds | Standard Deviation 9.34 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 7, 4 hours post-dose, n= 15 | 0.6 Milliseconds | Standard Deviation 9.03 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF Interval, Day 9 post-dose, n= 15 | 7.9 Milliseconds | Standard Deviation 8.53 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 1, 4 hours post-dose, n= 16 | 4.7 Milliseconds | Standard Deviation 8.49 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 4, Pre-dose, n= 15 | 5.5 Milliseconds | Standard Deviation 18.5 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 4, 2 hours post-dose, n= 15 | 2.5 Milliseconds | Standard Deviation 12.37 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 4, 4 hours post-dose, n= 15 | 4.3 Milliseconds | Standard Deviation 8.52 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 7, Pre-dose, n= 15 | 4.6 Milliseconds | Standard Deviation 16.31 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 7, 4 hours post-dose, n= 15 | -1.7 Milliseconds | Standard Deviation 12.06 |
| TAF/FTC | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB Interval, Day 9 post-dose, n= 15 | 10.3 Milliseconds | Standard Deviation 12.19 |
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.
Time frame: 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
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Heart Rate | Day 1, 2 hours post-dose, n= 16 | 5.0 Beats per minute | Standard Deviation 4.37 |
| TAF/FTC | Period 2: Change From Baseline in Heart Rate | Day 1, 4 hours post-dose, n= 16 | 2.8 Beats per minute | Standard Deviation 6.62 |
| TAF/FTC | Period 2: Change From Baseline in Heart Rate | Day 4, Pre-dose, n= 15 | -0.5 Beats per minute | Standard Deviation 11.1 |
| TAF/FTC | Period 2: Change From Baseline in Heart Rate | Day 4, 2 hours post-dose, n= 15 | 3.3 Beats per minute | Standard Deviation 5.86 |
| TAF/FTC | Period 2: Change From Baseline in Heart Rate | Day 4, 4 hours post-dose, n= 15 | -0.3 Beats per minute | Standard Deviation 5.13 |
| TAF/FTC | Period 2: Change From Baseline in Heart Rate | Day 7, Pre-dose, n= 15 | 0.3 Beats per minute | Standard Deviation 11.18 |
| TAF/FTC | Period 2: Change From Baseline in Heart Rate | Day 7, 2 hours post-dose, n= 15 | 1.8 Beats per minute | Standard Deviation 6.72 |
| TAF/FTC | Period 2: Change From Baseline in Heart Rate | Day 7, 4 hours post-dose, n= 15 | -2.3 Beats per minute | Standard Deviation 7.08 |
| TAF/FTC | Period 2: Change From Baseline in Heart Rate | Day 9 post-dose, n= 15 | 2.1 Beats per minute | Standard Deviation 7.84 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Erythrocytes | Day 3, n= 16 | -0.113 Trillion cells per liter | Standard Deviation 0.1123 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Erythrocytes | Day 7, n= 15 | 0.000 Trillion cells per liter | Standard Deviation 0.1466 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Erythrocytes | Day 9, n= 15 | -0.189 Trillion cells per liter | Standard Deviation 0.1697 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Hematocrit | Day 3, n= 16 | -0.0147 Proportion of red blood cells in blood | Standard Deviation 0.00982 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Hematocrit | Day 7, n= 15 | -0.0007 Proportion of red blood cells in blood | Standard Deviation 0.01369 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Hematocrit | Day 9, n= 15 | -0.0204 Proportion of red blood cells in blood | Standard Deviation 0.01371 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Hemoglobin | Day 9, n= 15 | -6.4 Grams per liter | Standard Deviation 5.55 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Hemoglobin | Day 3, n= 16 | -3.9 Grams per liter | Standard Deviation 3.51 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Hemoglobin | Day 7, n= 15 | -1.1 Grams per liter | Standard Deviation 4.58 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of MCH | Day 3, n= 16 | -0.11 Picograms | Standard Deviation 0.205 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of MCH | Day 7, n= 15 | -0.21 Picograms | Standard Deviation 0.203 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of MCH | Day 9, n= 15 | -0.17 Picograms | Standard Deviation 0.253 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of MCV | Day 3, n= 16 | -1.02 Femtoliters | Standard Deviation 0.483 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of MCV | Day 7, n= 15 | -0.17 Femtoliters | Standard Deviation 0.472 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of MCV | Day 9, n= 15 | -0.82 Femtoliters | Standard Deviation 0.499 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils, Period 2 Day 9, n= 15 | 0.003 Giga cells per liter | Standard Deviation 0.015 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils, Period 2 Day 3, n=15 | -0.023 Giga cells per liter | Standard Deviation 0.0811 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes, Period 2 Day 3, n= 16 | -0.158 Giga cells per liter | Standard Deviation 0.2296 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes, Period 2 Day 7, n= 15 | -0.105 Giga cells per liter | Standard Deviation 0.2306 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils, Period 2 Day 7, n= 15 | -0.417 Giga cells per liter | Standard Deviation 0.9069 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils, Period 2 Day 9, n= 15 | -0.282 Giga cells per liter | Standard Deviation 1.0161 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelets, Period 2 Day 9, n= 15 | 16.2 Giga cells per liter | Standard Deviation 38.11 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils, Period 2 Day 3, n= 15 | -0.004 Giga cells per liter | Standard Deviation 0.0196 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils, Period 2 Day 7, n= 15 | -0.002 Giga cells per liter | Standard Deviation 0.0204 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils, Period 2 Day 7, n=15 | -0.039 Giga cells per liter | Standard Deviation 0.1058 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils, Period 2 Day 9, n=16 | -0.043 Giga cells per liter | Standard Deviation 0.1093 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes, Period 2 Day 3, n= 16 | -0.053 Giga cells per liter | Standard Deviation 0.1895 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes, Period 2 Day 7, n= 15 | -0.077 Giga cells per liter | Standard Deviation 0.1709 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes, Period 2 Day 9, n= 15 | -0.104 Giga cells per liter | Standard Deviation 0.1672 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Leukocytes, Period 2 Day 3, n= 16 | -1.06 Giga cells per liter | Standard Deviation 1.188 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Leukocytes, Period 2 Day 7, n= 15 | -0.61 Giga cells per liter | Standard Deviation 1.05 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Leukocytes, Period 2 Day 9, n= 15 | -0.49 Giga cells per liter | Standard Deviation 1.193 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes, Period 2 Day 9, n= 15 | -0.111 Giga cells per liter | Standard Deviation 0.2728 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils, Period 2 Day 3, n= 16 | -0.868 Giga cells per liter | Standard Deviation 0.9597 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelets, Period 2 Day 3, n= 16 | 9.2 Giga cells per liter | Standard Deviation 20.41 |
| TAF/FTC | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelets, Period 2 Day 7, n= 15 | 19.8 Giga cells per liter | Standard Deviation 43.02 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in pH of Urine | Day 3, n= 16 | 0.19 pH | Standard Deviation 0.479 |
| TAF/FTC | Period 2: Change From Baseline in pH of Urine | Day 7, n= 15 | 0.10 pH | Standard Deviation 0.471 |
| TAF/FTC | Period 2: Change From Baseline in pH of Urine | Day 9, n= 15 | 0.10 pH | Standard Deviation 0.507 |
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.
Time frame: Baseline and at Days 4, 7, 9, and 10
Population: Safety Population. Only those participants with data available at the specified time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Pulse Rate | Day 4 | 2.4 Beats per minute | Standard Deviation 18.62 |
| TAF/FTC | Period 2: Change From Baseline in Pulse Rate | Day 7 | 1.9 Beats per minute | Standard Deviation 15.62 |
| TAF/FTC | Period 2: Change From Baseline in Pulse Rate | Day 9 | -0.3 Beats per minute | Standard Deviation 10.2 |
| TAF/FTC | Period 2: Change From Baseline in Pulse Rate | Day 10 | 9.5 Beats per minute | Standard Deviation 11.12 |
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.
Time frame: Baseline and at Days 4, 7, 9, and 10
Population: Safety Population. Only those participants with data available at the specified time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Respiratory Rate | Day 9 | -0.8 Breaths per minute | Standard Deviation 2.11 |
| TAF/FTC | Period 2: Change From Baseline in Respiratory Rate | Day 10 | -1.5 Breaths per minute | Standard Deviation 2.33 |
| TAF/FTC | Period 2: Change From Baseline in Respiratory Rate | Day 4 | -3.2 Breaths per minute | Standard Deviation 3.61 |
| TAF/FTC | Period 2: Change From Baseline in Respiratory Rate | Day 7 | -2.4 Breaths per minute | Standard Deviation 2.85 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Specific Gravity of Urine | Day 7, n= 15 | 0.0024 Ratio | Standard Deviation 0.00608 |
| TAF/FTC | Period 2: Change From Baseline in Specific Gravity of Urine | Day 9, n= 15 | 0.0005 Ratio | Standard Deviation 0.00872 |
| TAF/FTC | Period 2: Change From Baseline in Specific Gravity of Urine | Day 3, n= 16 | 0.0031 Ratio | Standard Deviation 0.00666 |
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.
Time frame: Baseline and at Days 4, 7, 9, and 10
Population: Safety Population. Only those participants with data available at the specified time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Temperature | Day 4 | -0.10 Degree Celsius | Standard Deviation 0.344 |
| TAF/FTC | Period 2: Change From Baseline in Temperature | Day 7 | -0.07 Degree Celsius | Standard Deviation 0.337 |
| TAF/FTC | Period 2: Change From Baseline in Temperature | Day 9 | -0.01 Degree Celsius | Standard Deviation 0.386 |
| TAF/FTC | Period 2: Change From Baseline in Temperature | Day 10 | 0.07 Degree Celsius | Standard Deviation 0.32 |
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.
Time frame: Baseline and at Days 3, 7, 9
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAF/FTC | Period 2: Change From Baseline in Urine Urobilinogen | Day 7, n= 15 | 0.0000 Micromoles per liter | Standard Deviation 0 |
| TAF/FTC | Period 2: Change From Baseline in Urine Urobilinogen | Day 3, n= 16 | 0.0000 Micromoles per liter | Standard Deviation 0 |
| TAF/FTC | Period 2: Change From Baseline in Urine Urobilinogen | Day 9, n= 15 | 0.0000 Micromoles per liter | Standard Deviation 0 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 2: Cmax of GSK3640254 | 1.411 Nanogram per milliliter | Geometric Coefficient of Variation 26.4 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAF/FTC | Period 2: Ctau of GSK3640254 | 0.7883 Nanogram per milliliter | Geometric Coefficient of Variation 30.3 |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAF/FTC | Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 | 5.000 Hours |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAF/FTC | Period 2: Tmax of FTC | 1.500 Hours |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAF/FTC | Period 2: Tmax of TAF | 1.000 Hours |
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.
Time frame: 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
Population: PK Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAF/FTC | Period 2: Tmax of TFV | 3.000 Hours |