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A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone Following Administration of Abiraterone Acetate Tablets in Healthy Adult Men

NCT01588782 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-11-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetics, safety, and potential for drug-drug interactions when a strong inhibitor of CYP3A4 (ie, ketoconazole) is co-administered with abiraterone acetate in healthy adult men.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Period 1: Abiraterone

1000 mg abiraterone acetate tablet administered orally on Day 1

DRUG

Period 2: Abiraterone/Ketoconazole

400 mg ketoconazole tablets administered orally on Days 11 to 16

DRUG

Period 2: Abiraterone/Ketoconazole

1000 mg abiraterone acetate tablet administered orally on Day 14

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Belgium

Study Locations

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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 NCT01588782 on ClinicalTrials.gov