MedTrace Logo

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

NCT01575587 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2014-01-10

No results posted yet for this study

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.

Conditions

  • Pharmacology

Interventions

DRUG

Abiraterone: Treatment A

1000 mg abiraterone acetate administered in the fasting state

DRUG

Abiraterone: Treatment B

Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose

DRUG

Abiraterone: Treatment C

Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose

DRUG

Abiraterone: Treatment D

Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01575587 on ClinicalTrials.gov