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A Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Patients

NCT01798628 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-02-26

No results posted yet for this study

Summary

The purpose of this study is to determine the effect of food on the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate 1000 mg when administered as a single dose in healthy male volunteers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Treatment A: abiraterone acetate

1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal

DRUG

Treatment B: abiraterone acetate

1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal

DRUG

Treatment C: abiraterone acetate

1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state

Sponsors & Collaborators

  • Cougar Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Cougar Biotechnology, Inc. Clinical Trial · Cougar Biotechnology, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-10-31
Completion
2009-10-31

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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 NCT01798628 on ClinicalTrials.gov