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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland
ClinicalTrials.gov Identifier:
NCT01615614
First received: June 6, 2012
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Rilpivirine
Drug: Rifabutin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study in Healthy Subjects, to Explore the Pharmacokinetics of Different Dosing Regimens of Rilpivirine in Combination With Rifabutin, at Steady-State

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Janssen R&D Ireland:

Primary Outcome Measures:
  • Pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin, at steady-state [ Time Frame: Up to 168 hours (postdose) ] [ Designated as safety issue: No ]
    Pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin, at steady-state will be evaluated.


Secondary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 87 days ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events will be evaluated to assess safety and tolerability.


Enrollment: 20
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
Rilpivirine 25 mg once daily will be administered for 11 days
 Drug: Rilpivirine
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.
Experimental: Treatment B
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
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.
Drug: Rifabutin
Type=exact number, unit=mg, number=150, form=capsule, route=oral. Two capsules daily will be administered for 17 days.
Experimental: Treatment C
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
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.
Drug: Rifabutin
Type=exact number, unit=mg, number=150, form=capsule, route=oral. Two capsules daily will be administered for 17 days.

Detailed Description:

This is a Phase I, open-label (the participant will know the identity of the treatment they receive), 3-period study to investigate the pharmacokinetic (what the body does to the medication) interaction of steady-state (constant concentrations in your blood resulting from a fixed dosing regimen) rilpivirine and steady-state rifabutin. Twenty healthy participants will be enrolled and will receive 3 different treatments (treatment A: rilpivirine 25 mg once daily administered daily for 11 days; treatment B: rilpivirine 50 mg once daily administered for 11 days + rifabutin 300 mg daily administered for 17 days; treatment C: rilpivirine (in a regimen to be determined based on an interim analysis of treatments A and B) administered for 11 days + rifabutin 300 mg daily administered for 17 days). All 20 participants will be randomized (the study drug is assigned by chance) to receive treatments A (10 participants) and treatment B (10 participants) and there will be a washout period of at least 21 days between treatments A and B. After all participants have completed treatments A and B, there will be an interim analysis to decide upon the dosing regimen for rilpivirine in treatment C (the rilpivirine regimen in treatment C could be either once daily or twice daily with a total daily dose of rilpivirine between 25 and 75 mg). All 20 participants will receive treatment C. Safety and tolerability will be evaluated throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615614

Locations
Belgium
Merksem, Belgium
Sponsors and Collaborators
Janssen R&D Ireland
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01615614     History of Changes
Other Study ID Numbers: CR100812, TMC278IFD1003, 2012-000141-12
Study First Received: June 6, 2012
Last Updated: March 19, 2013
Health Authority: Belgium: Ministry for Public Health
Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen R&D Ireland:
Rilpivirine
Rifabutin
Pharmacokinetics
Healthy participants

Additional relevant MeSH terms:
Rifabutin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Antibiotics, Antitubercular
Antitubercular Agents

ClinicalTrials.gov processed this record on May 19, 2013