A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Abiraterone in Healthy Male Participants
Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Abiraterone acetate (Drug); Rifampicin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Janssen Research & Development, LLC Official(s) and/or principal investigator(s): Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC
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.
Clinical Details
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 design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximum plasma concentration (Cmax) of abiraterone in Period 1 and Period 2Area under the plasma concentration-time curve (AUC) of abiraterone in Period 1 and Period 2 Time to reach the maximum plasma concentration (tmax) of abiraterone in Period 1 and Period 2 Eliminaton half-life (t1/2) of abiraterone in Period 1 and Period 2
Secondary outcome: Number of participants with adverse events
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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
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
Locations and Contacts
Merksem, Belgium
Additional Information
Starting date: January 2012
Last updated: January 8, 2013
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