Overview

A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate after oral administration of abiraterone acetate at different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under fasted conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Abiraterone Acetate
Criteria
Inclusion Criteria:

- Body mass index within 18 to 27 kg/m2 (inclusive) and body weight above 50 kg at
screening

- Protocol-defined laboratory and electrocardiogram parameters

- Negative test results for selected medications and substances of abuse and negative
exhaled carbon monoxide test at check-in day of each period

- Agrees to protocol-defined use of effective contraception

- Willing to be confined at the clinical research facility for time period specified in
the protocol

Exclusion Criteria:

- Significant history or current manifestation of any significant metabolic, allergic,
dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular,
gastrointestinal, neurological, or psychiatric disorder

- History of hypersensitivity reaction to the study medication or related compounds or
excipients used in the formulation

- Confirmed hepatitis A, B, or C infection or human immunodeficiency virus (HIV) 1 or
HIV-2 infection at screening

- Serum testosterone level of <200 ng/dL

- Use of any tobacco or nicotine-containing products

- Known or suspected use of illicit drugs in the last year

- Protocol contraindicated medications/preparations (prescription and non-prescription)