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

Phase 1 Completed 51 enrolled Janssen Research & Development, LLC

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start: 2012-01
Primary completion: 2012-05
Completion: 2012-05

Publications

Inoue K, Shishido A, Vaccaro N, Jiao J, Stieltjes H, Bernard A, Yu M, Chien C. Pharmacokinetics of abiraterone in healthy Japanese men: dose-proportionality and effect of food timing. Cancer Chemother Pharmacol. 2015 Jan;75(1):49-58. doi: 10.1007/s00280-014-2616-4. Epub 2014 Oct 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abiraterone acetate	Small molecule	1000 mg	—

Indications

No indication recorded.