NCT01655147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

January 23, 2012

Last Update Submit

January 8, 2013

Conditions

Healthy

Keywords

HealthyPharmacokineticsAbiraterone acetateAbirateroneJNJ-589485JNJ-212082ZytigaRifampicinRifadinCYP3A4 inducer

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (1)

  • Number of participants with adverse events

    Up to 31 days

Study Arms (1)

Abiraterone acetate + Rifampicin

EXPERIMENTAL

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 acetateDrug: Rifampicin

Interventions

Abiraterone acetateDRUG

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.

Also known as: ZYTIGA
Abiraterone acetate + Rifampicin
RifampicinDRUG

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

Also known as: RIFADIN
Abiraterone acetate + Rifampicin

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Interventions

Abiraterone AcetateRifampin

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic Compounds

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

August 1, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

BE(1)