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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01588782
First received: January 9, 2012
Last updated: November 23, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
 Drug: Period 1: Abiraterone
Drug: Period 2: Abiraterone/Ketoconazole
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Mean plasma concentrations of abiraterone [ Time Frame: Up to Day 17 ] [ Designated as safety issue: No ]
  • Mean plasma concentrations of ketoconazole [ Time Frame: Up to Day 14 ] [ Designated as safety issue: No ]
  • Maximum plasma concentrations of abiraterone [ Time Frame: Up to Day 17 ] [ Designated as safety issue: No ]
  • Time to reach the maximum plasma concentration of abiraterone [ Time Frame: Up to Day 17 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time 0 to time to the last quantifiable concentration of abiraterone [ Time Frame: Up to Day 17 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone [ Time Frame: Up to Day 17 ] [ Designated as safety issue: No ]
  • Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone [ Time Frame: Up to Day 17 ] [ Designated as safety issue: No ]
  • First-order rate constant associated with the terminal portion of the curve of abiraterone [ Time Frame: Up to Day 17 ] [ Designated as safety issue: No ]
  • Time to last quantifiable plasma concentration of abiraterone [ Time Frame: Up to Day 17 ] [ Designated as safety issue: No ]
  • Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone [ Time Frame: Up to Day 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of participants affected by an adverse event [ Time Frame: Up to end of study or early withdrawal ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2012
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588782

Locations
Belgium
Merksem, Belgium
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01588782     History of Changes
Other Study ID Numbers: CR100650, 212082PCR1002
Study First Received: January 9, 2012
Last Updated: November 23, 2012
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Janssen Research & Development, LLC:
Healthy volunteers
Pharmacology
Pharmacokinetics
Pharmacodynamics
Drug-drug interactions
 CYP3A4
Abiraterone acetate
JNJ-589485
JNJ-212082
Ketoconazole

Additional relevant MeSH terms:
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013