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Rifampicin

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Jan 10, 2013

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

Rifampicin · 1 trial · 1 indication

Phase 1 1
NCT01655147A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Abiraterone in Healthy Male ParticipantsHealthy
COMPLETED19 Analytics
PHASE1COMPLETED
A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Abiraterone in Healthy Male Participants
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Study Endpoints

Primary Endpoints

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 Endpoints

Number of participants with adverse events
Up to 31 days
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Study Design & Arms

MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Abiraterone acetate + RifampicinEXPERIMENTALAbiraterone 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.

Interventions

NameTypeDescription
Abiraterone acetateDRUGType=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.
RifampicinDRUGType=exact number, unit=mg, number=600, form=capsule, route=oral. Rifampicin administered on Days 8 to 13 of Period 2.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 pur...

Countries:Belgium
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Frequently asked questions about Rifampicin

What is Rifampicin used for?

Rifampicin is an investigational small molecule being studied for its effect on the pharmacokinetics of abiraterone in healthy male participants. It is not approved for any indication and is currently in Phase 1 clinical development.

Who makes Rifampicin?

Rifampicin is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical research on this drug in healthy volunteers.

What phase is Rifampicin in?

Rifampicin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is Rifampicin in?

Rifampicin has one completed clinical trial, NCT01655147, titled "A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Abiraterone in Healthy Male Participants." This Phase 1 study enrolled 19 healthy male participants in Belgium.

Is Rifampicin FDA approved?

Rifampicin is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, and its safety and efficacy have not been established for any medical use.