Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TMC278FDCHIV4001 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the pharmacokinetics (PK) of rilpivirine/Tenofovir/Emtricitabine (RPV/TFV/FTC) after a single-oral administration of Complera (the fixed-dose combination of RPV, FTC, Tenefovir disoproxil fumarate [TDF]) to healthy Japanese adult male participants.
This is a single center, open-label, single oral dose study in healthy Japanese adult male participants. The study consists of 3 phases; a screening phase up to 27 days (Day -28 to Day -2), an in-patient phase from Day -1 to Day 3 (dosing day is Day 1), and a follow-up assessment phase from Day 4 to the last follow-up assessment scheduled on Day 15 or at the time of early withdrawal. All participants will receive a single oral dose of one Complera tablet on Day 1 within 5 minutes after completion of the standardized breakfast. Pharmacokinetics of RPV/TFV/FTC will be assessed as the primary objective of the study. Safety of each participant will be assessed throughout the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine | Experimental | Participants will receive single oral dose of fixed dose combination (FDC) tablet comprising of Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDC | Drug | Fixed dose combination tablet contains 25 milligram (mg) of Rilpivirine, 300 mg of Tenofovir Disoproxil Fumarate (TDF) and 200 mg of Emtricitabine (FTC). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | The Cmax is the maximum observed plasma concentration of rilpivirine, tenofovir, emtricitabine. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | The Tmax is defined as actual sampling time to reach maximum observed analyte (rilpivirine/tenofovir/emtricitabine) concentration. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) | The AUC (0-last) is the area under the plasma concentration-time curve for rilpivirine/tenofovir/emtricitabine from time zero to last quantifiable time. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) | The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose |
| Elimination Rate Constant (Lambda[z]) | Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Experience Adverse Events | As a measure of safety and tolerability. | Up to 17 days following study drug administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trials | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan |
Not provided
| Label | URL |
|---|---|
| An Open-Label Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After Single-Oral Administration of Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine Fixed-Dose Combination Tablet in Healthy Japanese Adult Male Subjects | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose |
| Elimination Half-Life (t1/2) | The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose |
| Apparent Volume of Distribution (Vdz/F) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vdz/F) is influenced by the fraction absorbed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose |
| Apparent Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose |
| ID | Term |
|---|---|
| D000068696 | Rilpivirine |
| D000068678 | Emtricitabine, Rilpivirine, Tenofovir Drug Combination |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided