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

NCT01873001 | Completed Phase 1

• 3 other identifiers: CR101970212082PCR10112013-001408-12
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy volunteers; Drug-drug Interaction; Pharmacokinetics; Abiraterone; JNJ-589485; Abiraterone acetate; JNJ-212082; Pioglitazone HCl

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Abiraterone acetate + pioglitazone HCl

EXPERIMENTAL

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.

Drug: Pioglitazone HCl; Drug: Abiraterone acetate

Interventions

Pioglitazone HCl DRUG

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

Abiraterone acetate + pioglitazone HCl

Abiraterone acetate DRUG

1000 mg tablets administered by mouth on Day 8

Abiraterone acetate + pioglitazone HCl

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Interventions

Pioglitazone; Abiraterone Acetate

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 7, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 17, 2014

Record last verified: 2014-04

Locations

BE (1)