Overview

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

Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Abiraterone Acetate
Ketoconazole
Criteria
Inclusion Criteria:

- Body mass index (BMI) between 18 and 30 kg/m2, inclusive

Exclusion Criteria:

- History of or current clinically significant medical illness including (but not limited
to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation
disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities,
significant pulmonary disease, including bronchospastic respiratory disease, diabetes
mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric
disease, infection, or any other illness that the investigator considers should exclude the
participant or that could interfere with the interpretation of the study results