A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Abiraterone in Healthy Male Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01655147
First received: January 23, 2012
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to assess the effects of repeated daily administration of rifampicin on the pharmacokinetics (what the body does to the medication) of abiraterone following single-dose administration of abiraterone acetate tablets in healthy male participants.


Condition Intervention Phase
Healthy
Drug: Abiraterone acetate
Drug: Rifampicin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Drug-Drug Interaction Study to Assess the Effect of Rifampicin on the Pharmacokinetics of Abiraterone (JNJ-589485) Following Administration of Abiraterone Acetate (JNJ-212082) Tablets in Healthy Male Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Maximum plasma concentration (Cmax) of abiraterone in Period 1 and Period 2 [ Time Frame: Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17 ] [ Designated as safety issue: No ]
    Pharmacokinetic parameter Cmax of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2.

  • Area under the plasma concentration-time curve (AUC) of abiraterone in Period 1 and Period 2 [ Time Frame: Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17 ] [ Designated as safety issue: No ]
    Pharmacokinetic parameter AUC of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2.

  • Time to reach the maximum plasma concentration (tmax) of abiraterone in Period 1 and Period 2 [ Time Frame: Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17 ] [ Designated as safety issue: No ]
    Pharmacokinetic parameter tmax of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2.

  • Eliminaton half-life (t1/2) of abiraterone in Period 1 and Period 2 [ Time Frame: Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17 ] [ Designated as safety issue: No ]
    Pharmacokinetic parameter t1/2 of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2.


Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Up to 31 days ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: January 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abiraterone acetate + Rifampicin
Abiraterone acetate 1,000 mg (4 x 250 mg) on Day 1 of Period 1. Rifampicin 600 mg (2 x 300 mg) on Days 8 to 13, and Abiraterone acetate 1,000 mg (4 x 250 mg) on Day 14 of Period 2.
Drug: Abiraterone acetate
Type=exact number, unit=mg, number=1,000, form=tablet, route=oral. Abiraterone acetate administered on Day 1 of Period 1, and Day 14 of Period 2.
Other Name: ZYTIGA
Drug: Rifampicin
Type=exact number, unit=mg, number=600, form=capsule, route=oral. Rifampicin administered on Days 8 to 13 of Period 2.
Other Name: RIFADIN

Detailed Description:

This is an open-label (all people know the identity of the intervention), single-center (study conducted at one site), 2-period, sequential-design (studies that combine both longitudinal and cross sectional methods), to evaluate the effects of rifampicin on the pharmacokinetics of abiraterone acetate in healthy male participants. The study consists of a screening phase, an open-label treatment phase, and a follow up phase. The screening phase will be within 14 days before the first study medication administration. The treatment phase will consist of 2 treatment periods, Period 1: a single oral dose of abiraterone acetate tablets, and Period 2: a daily oral dose of rifampicin capsules alongwith a single oral dose of abiraterone acetate tablets. The 2 periods will be separated by a washout period of at least 7 days. Blood sample collection for pharmacokinetic assessments will be done for determination of abiraterone and rifampicin concentrations. The follow up phase will be of 14 days. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examinations will be monitored throughout the study. The total study duration will be approximately 31 days.

  Eligibility

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

Inclusion Criteria:

  • Must have blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
  • Must have a 12-lead electrocardiogram consistent with normal cardiac conduction and function
  • Must sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
  • Must agree to use an adequate contraception method and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
  • Have willingness to participate in the optional pharmacogenomic component of this study, participants (or their legally acceptable representative) must have signed the informed consent form

Exclusion Criteria:

  • History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, and others
  • Clinically significant abnormal values for hematology or clinical chemistry at screening or at admission to the study center
  • Serum testosterone level of < 200 ng/dL (at screening)
  • Clinically significant renal laboratory findings including specifically, creatinine, and creatinine clearance
  • Clinically significant hepatic laboratory findings or signs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655147

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: NCT01655147     History of Changes
Other Study ID Numbers: CR100651, 212082PCR1003, 2011-003490-28
Study First Received: January 23, 2012
Last Updated: January 8, 2013
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
Pharmacokinetics
Abiraterone acetate
Abiraterone
JNJ-589485
JNJ-212082
Zytiga
Rifampicin
Rifadin
CYP3A4 inducer

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014