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A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Abiraterone in Healthy Male Participants

NCT01655147 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2013-01-10

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Abiraterone acetate

Type=exact number, unit=mg, number=1,000, form=tablet, route=oral. Abiraterone acetate administered on Day 1 of Period 1, and Day 14 of Period 2.

DRUG

Rifampicin

Type=exact number, unit=mg, number=600, form=capsule, route=oral. Rifampicin administered on Days 8 to 13 of Period 2.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01655147 on ClinicalTrials.gov