Overview

A Comparative Study of Bioavailability of 3 New Abiraterone Acetate Tablets With Current Commercial Tablet

Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet formulations compared with the current commercial abiraterone acetate tablet formulation in healthy male participants, under fasted conditions, at a single dose of 1000 mg.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Abiraterone Acetate
Criteria
Inclusion Criteria:

- Have body weight not less than 50 kg

- Must be a non-smoker, and has no history of smoking or use of nicotine-containing
substances within the previous 2 months

- Must have blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher
than 90 mmHg diastolic

- Must have a 12-lead electrocardiogram consistent with normal cardiac conduction and
function

- Must agree to use an adequate contraception method as deemed appropriate by the
investigator and to not donate sperm during the study for 3 months after receiving the
last dose of study medication

Exclusion Criteria:

- History of or current clinically significant medical illness including cardiac
arrhythmias or other cardiac disease that could interfere with the interpretation of
the study results

- Clinically significant abnormal values for hematology or urinalysis (at screening)

- Clinically significant abnormal physical examination vital signs or 12-lead
electrocardiogram (at screening)

- Usage of any prescription or nonprescription medication, except for acetaminophen, and
oral contraceptives and hormonal replacement therapy within 14 days before the first
dose of the study medication is scheduled

- Unable to swallow solid, oral dosage forms whole with the aid of water (participants
may not chew, divide, dissolve, or crush the study medication)