HealthyPhase 1NCT01615614
A Study to Explore the Pharmacokinetics of Rilpivirine With Rifabutin in Healthy Participants
A Phase 1 study testing Rilpivirine and Rifabutin in people with Healthy, run by Janssen R&D Ireland at 1 site in Belgium.
Trial summary
The purpose of this study is to explore the pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rilpivirine and Rifabutin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to explore the pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin in healthy participants.
Read the 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.
- Conditions
- Healthy
- Being tested
- Rilpivirine, Rifabutin
- Keywords
- Rilpivirine, Rifabutin, Pharmacokinetics, Healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilpivirineDrug
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.
RifabutinDrug
Type=exact number, unit=mg, number=150, form=capsule, route=oral. Two capsules daily will be administered for 17 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Rilpivirine 25 mg once daily will be administered for 11 days Receives: 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 Receives: 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. Receives: Drug: Rilpivirine; Drug: Rifabutin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 168 hours (postdose)
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability
Number of participants with adverse events will be evaluated to assess safety and tolerability.
Measured: Up to 87 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen R&D Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615614
- Sponsor's protocol ID
- CR100812
- Other IDs
- TMC278IFD1003, 2012-000141-12
- Status last verified
- Mar 2014
- First submitted
- 6 Jun 2012
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01615614
- Acronym / sponsor ID
- CR100812
- Conditions
- Healthy
- Keywords
- Rilpivirine, Rifabutin, Pharmacokinetics, Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Janssen R&D IrelandIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin in healthy participants.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: RilpivirineRilpivirine 25 mg once daily will be administered for 11 days |
| Treatment B | Experimental | Drug: Rilpivirine, Drug: RifabutinRilpivirine 50 mg once daily will be administered for 11 days and rifabutin 300 mg once daily will be administered for 17 days |
| Treatment C | Experimental | Drug: Rilpivirine, Drug: RifabutinRilpivirine (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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RilpivirineType=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 | Treatment A, Treatment B, Treatment C |
| RifabutinType=exact number, unit=mg, number=150, form=capsule, route=oral. Two capsules daily will be administered for 17 days. | Drug | Treatment B, Treatment C |
Primary outcome
Pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin, at steady-state
Time frame: Up to 168 hours (postdose)
Pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin, at steady-state will be evaluated.
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 87 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rilpivirine and Rifabutin in people with Healthy, run by Janssen R&D Ireland at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin, at steady-state (time frame: Up to 168 hours (postdose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2014.