Status:
COMPLETED
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 heal...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01873001
Start Date
May 1 2013
End Date
July 1 2013
Last Update
April 17 2014
Active Locations (1)
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1
Merksem, Belgium