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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655147
• Other study ID #: CR100651
• Secondary ID: 212082PCR1003201
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2012
• Last updated: January 8, 2013
• Start date: January 2012
• Est. completion date: March 2012

Study information

• Verified date: January 2013
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of abiraterone in Period 1 and Period 2	Pharmacokinetic parameter Cmax of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2.	Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17	No
Primary	Area under the plasma concentration-time curve (AUC) of abiraterone in Period 1 and Period 2	Pharmacokinetic parameter AUC of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2.	Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17	No
Primary	Time to reach the maximum plasma concentration (tmax) of abiraterone in Period 1 and Period 2	Pharmacokinetic parameter tmax of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2.	Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17	No
Primary	Eliminaton half-life (t1/2) of abiraterone in Period 1 and Period 2	Pharmacokinetic parameter t1/2 of abiraterone was measured when abiraterone acetate was administered in Period 1 and Period 2.	Period 1: Day 1 to Day 4; Period 2: Day 14 to Day 17	No
Secondary	Number of participants with adverse events		Up to 31 days	Yes