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)