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
Completed · Phase 1
Conditions studied: Pharmacology
In brief
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.
Key facts
- Study ID
- NCT01575587
- Run by
- Janssen Research & Development, LLC
- People needed
- 51
- Starts
- 2012-01-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2014-01-10
Who can join
Age: 25 and older, up to 35. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Healthy Caucasian and Japanese male individuals.
- Body mass index between 18 and 30 kg/m2.
- Body weight >=50 kg.
- A normal 12-lead electrocardiogram.
You may not qualify if…
- 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.
Where it is running
- Study site — Cypress, California, United States
Full record on ClinicalTrials.gov
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