A Study to Assess the Effect of Timing of Food Intake on the Pharmacokinetics of Abiraterone Following Single-Dose Administration of Abiraterone Acetate Tablets in Healthy Caucasian and Japanese Men

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the effect of timing of food intake on systemic abiraterone exposure observed in healthy adult Japanese and Caucasian men.

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

Details

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

Criteria

Inclusion Criteria:

• Healthy Caucasian and Japanese male individuals.

• Body mass index between 18 and 30 kg/m2.

• Body weight >=50 kg.

• A normal 12-lead electrocardiogram.

Exclusion Criteria:

• History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.

• Presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function.

• History of alcohol consumption of more than 4 drinks daily within 1 year prior to screening and unwillingness to abstain from alcohol-containing food or beverages from within 24 hours before Day-1 through study completion.

• History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years.

• Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies.

• History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or participant's verbal report.