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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Abiraterone Acetate; Rifampin

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