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

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT01640093

Run by

Janssen Research & Development, LLC

People needed

32

Starts

2012-05-01

Expected to finish

2012-07-01

Last updated by the study team

2013-03-04

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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