A Study to Explore the Pharmacokinetics of Rilpivirine With Rifabutin in Healthy Participants

NCT01615614 | Completed Phase 1

• 3 other identifiers: CR100812TMC278IFD10032012-000141-12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin in healthy participants.

Conditions

Healthy

Keywords

Rilpivirine; Rifabutin; Pharmacokinetics; Healthy participants

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin, at steady-state

  Pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin, at steady-state will be evaluated.

  Up to 168 hours (postdose)

Secondary Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerability

  Up to 87 days

Study Arms (3)

Treatment A

EXPERIMENTAL

Rilpivirine 25 mg once daily will be administered for 11 days

Drug: Rilpivirine

Treatment B

EXPERIMENTAL

Rilpivirine 50 mg once daily will be administered for 11 days and rifabutin 300 mg once daily will be administered for 17 days

Drug: Rilpivirine; Drug: Rifabutin

Treatment C

EXPERIMENTAL

Rilpivirine (in a regimen to be determined based on an interim pharmacokinetic analysis of treatment A and B) will be administered for 11 days and rifabutin 300 mg once daily will be administered for 17 days.

Drug: Rilpivirine; Drug: Rifabutin

Interventions

Rilpivirine DRUG

Type=exact number, unit=mg, number=25, 50, and will be determined after treatment A and B analysis form=tablet, route=oral. Once or twice daily with a total daily dose of rilpivirine between 25 and 75 mg will be administered for 11 days.

Treatment A; Treatment B; Treatment C

Rifabutin DRUG

Type=exact number, unit=mg, number=150, form=capsule, route=oral. Two capsules daily will be administered for 17 days.

Treatment B; Treatment C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants should be healthy on the basis of physical examination, medical history, vital signs, electrocardiogram, and the results of blood biochemistry and hematology tests and a urinalysis performed at screening
• Men must agree to use a highly effective method of birth control (ie, male condom with either female intrauterine device, diaphragm, cervical cap or hormone based contraceptives by their female partner), and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
• Women must be postmenopausal for at least 2 years, or be surgically sterile (have had a total hysterectomy or bilateral oophorectomy, tubal ligation/bilateral tubal clips without reversal operation, or otherwise be incapable of becoming pregnant)
• Women must have a negative pregnancy test at screening
• Participants must be non-smoking for at least 3 months prior to screening

You may not qualify if:

• A positive HIV-1 or HIV-2 test at screening
• History or suspicion of alcohol or barbiturate, amphetamine, recreational or narcotic drug use which in the Investigator's opinion would compromise subject safety and/or compliance with study procedures
• Hepatitis A, B or C infection (confirmed by hepatitis A IgM, HBsAg, or hepatitis C virus antibody, respectively) at screening
• Currently active clinically significant gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrine, renal, hepatic, respiratory, inflammatory or infectious disease
• Any history of tuberculosis, ocular herpes, or uveitis
• Currently significant diarrhea or gastric stasis that in the Investigator's opinion could influence drug absorption or bioavailability

Sponsors & Collaborators

• Janssen R&D Ireland: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Interventions

Rilpivirine; Rifabutin

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

BE (1)