A Study to Assess the Effect of Abiraterone (JNJ-589485) on the Pharmacokinetics of Pioglitazone Following Administration of Abiraterone Acetate (JNJ-212082) and Pioglitazone HCl Tablets in Healthy Male Participants

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the effects of abiraterone on the pharmacokinetics (study of what the body does to a drug) of pioglitazone when coadministered with abiraterone acetate in healthy adult male participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Abiraterone Acetate; Pioglitazone

Criteria

Inclusion Criteria:

• Agrees to protocol-defined use of effective contraception for 1 week after receiving the last dose of study drug

• Agrees to not donate sperm during the study and for 1 week after receiving the last dose of study drug

• Body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg

• Blood pressure between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic

• A 12-lead electrocardiogram consistent with normal cardiac conduction and function

• Non-smoker

• Laboratory values within protocol -defined parameters

Exclusion Criteria:

• History of or current clinically significant medical illness

• Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator

• Presence of sexual dysfunction or any medical condition that would affect sexual function

• Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram

• Use of any prescription or nonprescription medication (including vitamins and herbal supplements) before the first dose of the study drug is scheduled through study completion

• History of drug or alcohol abuse within 3 years before screening or positive test result(s) for alcohol and/or drugs of abuse at screening and Day -1 and at Day 7 of the treatment period

• Known allergy to the study drug or any of the excipients of the formulation

• History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (appendectomy and hernia repair will be allowed)

• Donated blood or blood products or had substantial loss of blood within 3 months before the first administration of study drug or intention to donate blood or blood products during the study

• Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled

• Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, hepatitis B core antibody or hepatitis C antibodies

• Preplanned surgery or procedures that would interfere with the conduct of the study