Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current commercial abiraterone acetate uncoated tablet formulation under fasted (without eating or drinking) conditions in healthy male participants.

Key facts

Study ID

NCT02230046

Run by

Janssen Research & Development, LLC

People needed

102

Starts

2014-10-01

Expected to finish

2014-11-01

Last updated by the study team

2016-01-20

Who can join

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

You may qualify if…

• If sexually active, participants must always use a condom during the study and for 1 week after last intake of study drug. If sexually active with a pregnant woman or woman of child-bearing potential, participants must agree to abstain from intercourse during the study and for 1 week after last intake of study drug. Participants should not donate sperm during the study and for 1 week after receiving the last dose of study drug
• Body mass index (BMI; weight [kilogram(kg)]/height\^2 [meter square (m\^2)]) between 18.5 and 30.0 kg/m\^2, (inclusive), and body weight not less than 50 kg
• Blood pressure (after the participants is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at Screening
• A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at Screening as specified in the protocol
• Non-smoker, no history of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or participant's verbal report

You may not qualify if…

• 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 participants or that could interfere with the interpretation of the study results
• Clinically significant abnormal values for hematology or clinical chemistry at Screening
• Presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function
• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of the study drug is scheduled through study completion
• History of, or a reason to believe a participants has a history of drug or alcohol abuse within the past 5 years

Where it is running

• Study site — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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