Clinical trial NCT01655147: A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Abiraterone in Healthy Male Participants
Official title: An Open-Label Drug-Drug Interaction Study to Assess the Effect of Rifampicin on the Pharmacokinetics of Abiraterone (JNJ-589485) Following Administration of Abiraterone Acetate (JNJ-212082) Tablets in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Pharmacokinetics
Abiraterone acetate
Abiraterone
JNJ-589485
JNJ-212082
Zytiga
Rifampicin
Rifadin
CYP3A4 inducer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-08-01
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effects of repeated daily administration of rifampicin on the pharmacokinetics (what the body does to the medication) of abiraterone following single-dose administration of abiraterone acetate tablets in healthy male participants.

Detailed description: This is an open-label (all people know the identity of the intervention), single-center (study conducted at one site), 2-period, sequential-design (studies that combine both longitudinal and cross sectional methods), to evaluate the effects of rifampicin on the pharmacokinetics of abiraterone acetate in healthy male participants. The study consists of a screening phase, an open-label treatment phase, and a follow up phase. The screening phase will be within 14 days before the first study medication administration. The treatment phase will consist of 2 treatment periods, Period 1: a single oral dose of abiraterone acetate tablets, and Period 2: a daily oral dose of rifampicin capsules alongwith a single oral dose of abiraterone acetate tablets. The 2 periods will be separated by a washout period of at least 7 days. Blood sample collection for pharmacokinetic assessments will be done for determination of abiraterone and rifampicin concentrations. The follow up phase will be of 14 days. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examinations will be monitored throughout the study. The total study duration will be approximately 31 days.

Eligibility criteria: Inclusion Criteria:

* Must have blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
* Must have a 12-lead electrocardiogram consistent with normal cardiac conduction and function
* Must sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
* Must agree to use an adequate contraception method and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
* Have willingness to participate in the optional pharmacogenomic component of this study, participants (or their legally acceptable representative) must have signed the informed consent form

Exclusion Criteria:

* History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, and others
* Clinically significant abnormal values for hematology or clinical chemistry at screening or at admission to the study center
* Serum testosterone level of \< 200 ng/dL (at screening)
* Clinically significant renal laboratory findings including specifically, creatinine, and creatinine clearance
* Clinically significant hepatic laboratory findings or signs

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of abiraterone in Period 1 and Period 2
timeFrame: Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17
measure: Area under the plasma concentration-time curve (AUC) of abiraterone in Period 1 and Period 2
timeFrame: Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17
measure: Time to reach the maximum plasma concentration (tmax) of abiraterone in Period 1 and Period 2
timeFrame: Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17
measure: Eliminaton half-life (t1/2) of abiraterone in Period 1 and Period 2
timeFrame: Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 31 days
Other outcomes:
Locations:
city: Merksem
country: Belgium
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: