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

NCT ID: NCT01873001

Last Updated: 2014-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-07-31

Brief 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.

Detailed Description

This is an open-label (identity of assigned study drug will be known) single-dose drug-drug interaction study to assess the effect of abiraterone on pioglitazone. Approximately 16 healthy adult male participants will be enrolled in this study. The study consists of a screening phase, an open-label treatment phase consisting of 2 single-dose treatment periods, end-of-study or withdrawal assessments done upon completion of the 72-hour pharmacokinetic sampling on Day 11 of Period 2 or upon withdrawal, and a follow-up visit 5 to 7 days after the last study procedure. The total study length is 32 days. Participants will receive pioglitazone alone on Day 1 (Period 1) of the study. On Day 8 (Period 2), participants will receive a single dose of abiraterone acetate followed by a single dose of pioglitazone one hour later. Successive pioglitazone administrations will be separated by a washout period of 7 days. Participants will be confined to the study center from Day -1 to Day 4 of Period 1 and from Day 7 to Day 11 of Period 2, at least 10 hours before each study drug administration until completion of the 72-hour blood sample collection for each period. A pharmacogenomic blood sample will be collected from all participants on Day -1. Safety will be monitored throughout the study.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abiraterone acetate + pioglitazone HCl

Participants will receive 15 mg pioglitazone on Day 1 (Period 1). On Day 8 (Period 2), participants will receive 1000 mg abiraterone acetate followed by 15 mg of pioglitazone one hour later.

Group Type: EXPERIMENTAL

Pioglitazone HCl

Intervention Type: DRUG

15 mg tablet administered by mouth on Day 1, and Day 8 1 hour after study drug administration

Abiraterone acetate

Intervention Type: DRUG

1000 mg tablets administered by mouth on Day 8

Interventions

Pioglitazone HCl

15 mg tablet administered by mouth on Day 1, and Day 8 1 hour after study drug administration

Intervention Type: DRUG

Abiraterone acetate

1000 mg tablets administered by mouth on Day 8

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Merksem, , Belgium

Countries

Belgium

Other Identifiers

212082PCR1011

Identifier Type: OTHER

Identifier Source: secondary_id

2013-001408-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR101970

Identifier Type: -

Identifier Source: org_study_id