A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone Following Administration of Abiraterone Acetate Tablets in Healthy Adult Men

An Open-Label Drug-Drug Interaction Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone (JNJ-589485) Following Administration of Abiraterone Acetate (JNJ-212082) Tablets in Healthy Male Subjects

The purpose of this study is to evaluate the pharmacokinetics, safety, and potential for drug-drug interactions when a strong inhibitor of CYP3A4 (ie, ketoconazole) is co-administered with abiraterone acetate in healthy adult men.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Period 1: Abiraterone; Drug: Period 2: Abiraterone/Ketoconazole; Drug: Period 2: Abiraterone/Ketoconazole

Detailed Description

This is a non-randomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), 2-period, sequential-design, drug-drug interaction study of abiraterone acetate and ketoconazole in approximately 20 healthy adult men. This study will consist of a screening period followed by an open-label treatment phase consisting of 2 treatment periods. Successive drug administration will be separated by a washout period of at least 10 days. All individuals will receive study treatment in the same sequence. Period 1 (Days 1 to 4) consists of a single oral dose of 1000 mg abiraterone acetate tablets on Day 1 only. Period 2 (Days 11 to 17) consists of a daily oral dose of 400 mg ketoconazole tablets on Days 11 to 16 and administration of a single dose of 1000 mg abiraterone acetate on Day 14. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected at each treatment period as detailed in the protocol. Safety will be monitored continuously from the time of informed consent signing until the end of the study.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Merksem, Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

- Body mass index (BMI) between 18 and 30 kg/m2, inclusive

Exclusion Criteria:

- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abiraterone acetate; All individuals will receive study treatment in the same sequence. Period 1 (Days 1 to 4) consists of a single oral dose of 1000 mg abiraterone acetate tablets on Day 1 only. Period 2 (Days 11 to 17) consists of a daily oral dose of 400 mg ketoconazole tablets on Days 11 to 16 and administration of a single dose of 1000 mg abiraterone acetate on Day 14.	Drug: Period 1: Abiraterone; 1000 mg abiraterone acetate tablet administered orally on Day 1; Drug: Period 2: Abiraterone/Ketoconazole; 400 mg ketoconazole tablets administered orally on Days 11 to 16; Drug: Period 2: Abiraterone/Ketoconazole; 1000 mg abiraterone acetate tablet administered orally on Day 14

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean plasma concentrations of abiraterone	Up to Day 17
Mean plasma concentrations of ketoconazole	Up to Day 14
Maximum plasma concentrations of abiraterone	Up to Day 17
Time to reach the maximum plasma concentration of abiraterone	Up to Day 17
Area under the plasma concentration-time curve from time 0 to time to the last quantifiable concentration of abiraterone	Up to Day 17
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone	Up to Day 17
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone	Up to Day 17
First-order rate constant associated with the terminal portion of the curve of abiraterone	Up to Day 17
Time to last quantifiable plasma concentration of abiraterone	Up to Day 17
Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone	Up to Day 17

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of participants affected by an adverse event	Up to end of study or early withdrawal

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: April 27, 2012
• First Posted (Estimate): May 1, 2012

Study Record Updates

• Last Update Posted (Estimate): November 27, 2012
• Last Update Submitted That Met QC Criteria: November 23, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Healthy volunteers; Pharmacokinetics; Abiraterone acetate; Pharmacodynamics; Pharmacology; CYP3A4; Ketoconazole; Drug-drug interactions; JNJ-589485; JNJ-212082
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Ketoconazole
• Other Study ID Numbers: CR100650; 212082PCR1002 (Other Identifier: Janssen Research & Development, LLC)