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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 2

Area 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

Page last updated: August 23, 2015

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