Clinical trial NCT02530060: A Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration in Healthy Japanese Adult Male Participants
Official title: An Open-Label Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration of a Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine Fixed-Dose Combination Tablet in Healthy Japanese Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Healthy
Rilpivirine
Tenofovir
Emtricitabine
Tenofovir Disoproxil Fumarate
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2015-08-20
Enrollment: 8
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Willing to adhere to the prohibitions and restrictions specified in this protocol
* Participant who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the dose of study drug
* Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2) (inclusive), and body weight not less than 50 kg
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
* Non-smoker or participant who habitually smokes no more than 10 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 60 mL/min), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
* Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening or at admission to the study center as deemed appropriate by the investigator
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the first dose of the study drug is scheduled until completion of the study
* History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition text revision or 5th edition) (DSM-IV or DSM-5) criteria or International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as benzodiazepines, cocaines, stimulants, cannabinoids, barbiturates, opiates, phencyclidines, and tricyclic antidepressants) at screening and on Day -1

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 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
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 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
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
timeFrame: 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
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
timeFrame: 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
measure: Elimination Rate Constant (Lambda[z])
timeFrame: 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
measure: Elimination Half-Life (t1/2)
timeFrame: 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
measure: Apparent Volume of Distribution (Vdz/F)
timeFrame: 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
measure: Apparent Clearance (CL/F)
timeFrame: 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
Secondary outcomes:
measure: Number of Participants who Experience Adverse Events
timeFrame: Up to 17 days following study drug administration
Other outcomes:
Locations:
city: Fukuoka
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trials
role: STUDY_DIRECTOR
References: