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

Healthy Volunteers Clinical Trial

Official title:

An Open-Label Drug-Drug Interaction 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 Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873001
• Other study ID #: CR101970
• Secondary ID: 212082PCR1011201
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2013
• Last updated: April 16, 2014
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: April 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Pioglitazone HCl
15 mg tablet administered by mouth on Day 1, and Day 8 1 hour after study drug administration
• Abiraterone acetate
1000 mg tablets administered by mouth on Day 8

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration of pioglitazone		Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Primary	Time to reach the maximum observed plasma concentration of pioglitazone		Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Primary	Area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of pioglitazone		Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Primary	Area under the plasma concentration-time curve from time 0 to infinite time of pioglitazone		Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Primary	Percentage of area under the plasma concentration time curve obtained by extrapolation of pioglitazone		Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Primary	Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of pioglitazone		Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Primary	Time to last observed quantifiable plasma concentration of pioglitazone		Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Secondary	Maximum observed plasma concentration of abiraterone		Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Secondary	Time to reach the maximum observed plasma concentration of abiraterone		Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Secondary	Area under the plasma concentration-time curve from time 0 to time of the last observed quantifiable concentration of abiraterone		Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Secondary	Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone		Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Secondary	Percentage of area under the plasma concentration-time curve obtained by extrapolation of abiraterone		Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Secondary	Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone		Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Secondary	Time to last observed quantifiable plasma concentration of abiraterone		Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Secondary	Apparent total plasma clearance of drug after extravascular administration of pioglitazone		Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Secondary	Metabolite to parent drug ratio for maximum observed plasma concentration		Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Secondary	Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to time of the last observed quantifiable concentration		Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Secondary	Metabolite to parent drug ratio for area under the plasma concentration time curve from time 0 to infinite time		Day 1 and Day 8 predose, and postdose at 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h	No
Secondary	Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)		Up to 30 days after the last dose of study medication	Yes