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)