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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01655147

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Abiraterone acetate Drug: Rifampicin	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Intervention Model:

Crossover Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: RIFADIN

Arm

Intervention/Treatment

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 Names:

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 Names:

RIFADIN

Outcome Measures

Primary Outcome Measures

Maximum plasma concentration (Cmax) of abiraterone in Period 1 and Period 2 [Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17]
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 [Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17]
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 [Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17]
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 [Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17]
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 [Up to 31 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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