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

NCT ID: NCT01655147

Last Updated: 2013-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-03-31

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Abiraterone acetate

Intervention Type: DRUG

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.

Rifampicin

Intervention Type: DRUG

Type=exact number, unit=mg, number=600, form=capsule, route=oral. Rifampicin administered on Days 8 to 13 of Period 2.

Interventions

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.

Intervention Type: DRUG

Rifampicin

Type=exact number, unit=mg, number=600, form=capsule, route=oral. Rifampicin administered on Days 8 to 13 of Period 2.

Intervention Type: DRUG

Other Intervention Names

ZYTIGA; RIFADIN

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Merksem, , Belgium

Countries

Belgium

Other Identifiers

212082PCR1003

Identifier Type: OTHER

Identifier Source: secondary_id

2011-003490-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100651

Identifier Type: -

Identifier Source: org_study_id