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

• Conditions: Pharmacology

• Registration Number: NCT01575587
• Lead Sponsor: Janssen Research & Development, LLC

Brief 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.

Detailed Description

This is a randomized (individuals will be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), single dose, 4-way crossover study of abiraterone acetate in approximately 48 healthy adult Japanese and Caucasian men. For the crossover design, the treatment sequences are defined as follows: 1 - ADBC, 2 - BACD, 3 - CBDA, and 4 - DCAB; where Treatment A = abiraterone acetate administered in the fasted state, Treatment B = standardized meal administered 1 hour after abiraterone acetate dose, Treatment C = standardized meal administered 2 hours after abiraterone acetate dose, and Treatment D = standardized meal administered 2 hours before and 2 hours after abiraterone acetate dose. This study will consist of a screening period followed by four open-label treatment periods separated by a washout period of at least 14 days between dosing. Eligible participants will be randomly assigned on Day 1 to 1 of 4 treatment sequences that differ with regard to timing of food intake before and/or after dosing with a single dose of 1000 mg of abiraterone acetate. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected during the open-label treatment phase as detailed in the protocol. Safety will be monitored throughout the study. End-of-study assessments will be performed on Day 4 of Period 4 or upon early withdrawal.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes in mean plasma concentrations of abiraterone	Up to Day 4, treatment period 4

Secondary Outcome Measures

Name	Time	Method
Mean plasma concentrations of abiraterone	Up to Day 4, treatment period 4
Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone	Up to Day 4, treatment period 4
Maximum plasma concentration of abiraterone	Up to Day 4, treatment period 4
Time to reach the maximum plasma concentration of abiraterone	Up to Day 4, treatment period 4
Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration of abiraterone	Up to Day 4, treatment period 4
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone	Up to Day 4, treatment period 4
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone	Up to Day 4, treatment period 4
First-order rate constant associated with the terminal portion of the curve of abiraterone	Up to Day 4, treatment period 4
Time to last quantifiable plasma concentration of abiraterone	Up to Day 4, treatment period 4
The number of participants affected by an adverse event	Up to the end of the study (4 days after final dose of study drug) or early withdrawal