HIVPhase 1NCT01268839
A Phase I, Open-label Trial to Explore the Pharmacokinetics, Safety and Tolerability of TMC278 (Rilpivirine) 25 mg Once Daily Following a 2-week Period Receiving Efavirenz, in Healthy Male and Female Volunteers
A Phase 1 study testing TMC278 and Efavirenz in people with HIV, run by Tibotec, Inc.
Trial summary
The purpose of this study is to investigate the pharmacokinetics of TMC278 (rilpivirine) 25 mg once daily following a preceding 2-week treatment period with efavirenz 600 mg once daily in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- TMC278 and Efavirenz
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to May 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-vasectomized heterosexually active male volunteers with female partner of childbearing potential must be using a highly effective method of birth control (i.e., male condom with either female intrauterine device, diaphragm, cervical cap or hormonal based contraceptives) and must agree to use these birth control methods during the trial and until 30 days after the end of the trial
- Able to comply with all protocol requirements
- Normal resting ECG at screening including
- Volunteers must have signed an Informed Consent Form (ICF) voluntarily before the first trial-related activity indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial
- To participate in the optional pharmacogenomic component of this trial, volunteers must have signed the ICF for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the trial. Refusal to give consent for this component does not exclude a volunteers from participation in the clinical trial
- Healthy on the basis of a medical evaluation that confirms the absence of any clinically relevant abnormality and includes a physical examination (including skin examination), medical history, vital signs, the results of blood biochemistry and hematology tests and a urinalysis carried out at screening.
Who cannot join
- A positive HIV-1 or -2 test at trial screening
- Females of childbearing potential
- Hepatitis A infection (confirmed by hepatitis A antibody IgM), hepatitis B infection (confirmed by hepatitis B surface antigen), or hepatitis C infection (confirmed by hepatitis C virus antibody) diagnosed at trial screening
- Currently active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings during screening of medical history, laboratory or physical examination that in the investigator's opinion would compromise subject safety or the outcome of the trial
- Current or recent (within 3 months prior to the first administration of trial medication) gastrointestinal disease
- Any history of significant skin disease such as but not limited to rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis, or urticaria
- A positive alcohol test or urine drug test at study screening
About this study
Official title: A Phase I, Open-label Trial to Explore the Pharmacokinetics, Safety and Tolerability of TMC278 25 mg Once Daily Following a 2-week Period Receiving Efavirenz, in Healthy Male and Female Subjects
The purpose of this study is to investigate the pharmacokinetics of TMC278 (rilpivirine) 25 mg once daily following a preceding 2-week treatment period with efavirenz 600 mg once daily in healthy volunteers
Read the detailed description
This is a Phase I, open-label (all people involved know the identity of the intervention), single center trial in healthy HIV negative volunteers to investigate the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body, the rate at which a drug action begins, the duration of the effect, the chemical changes of the substance in the body, and the effects and routes of excretion of the metabolites) of the drug of rilpivirine (TMC278) 25 mg once daily (q.d.). An approximate total of 20 volunteers will be enrolled in this trial. All volunteers will receive 3 different treatments; o Treatment A: TMC278 25 mg q.d. administered for 14 days.; o Treatment B: efavirenz (EFV) 600 mg q.d. administered for 14 days.; o Treatment C: TMC278 25 mg q.d. administered for 28 days (4 weeks).; All volunteers will start with Treatment A followed by Treatment B. Treatments A and B will be separated by a washout period of at least 14 days but no more than 21 days. At the end of Treatment B, volunteers will continue with Treatment C. There will be no washout period between Treatments B and C.; Full pharmacokinetic profiles of TMC278 will be determined up to 24 hours postdose on Days 1 and 14 of Treatment A (references), Day 1 (immediately after cessation of EFV intake) of Treatment C (test), and on Days 14, 21, and 28 (2, 3, and 4 weeks after cessation of EFV intake, respectively) of Treatment C. Trough (C0h) samples for determination of TMC278 plasma; concentrations will be collected regularly in between. Blood samples for determination of EFV plasma concentrations will be collected at regular time points during Treatment B and during Treatment C after cessation of EFV intake.; Serum samples for potential future testing of ex vivo antiviral activity will be collected and stored.; A pharmacogenomic blood sample for potential future CYP2B6 genotyping will be collected and stored from subjects who consent separately to the pharmacogenomic component of the trial.; Safety and tolerability will be evaluated throughout the trial. Rilpivirine (TMC278) 25mg once daily for 14 days, No Treatment 14-21 days, Efavirenz 600mg once daily for 14 days, TMC278 25mg once daily for 28 days
- Conditions
- HIV
- Being tested
- TMC278, Efavirenz
- Keywords
- TMC278, rilpivirine, efavirenz, healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC278Drug
25mg tablet once daily for 28 days
TMC278Drug
25mg tablet once daily for 14 days
EfavirenzDrug
600mg tablet once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Efavirenz 600mg tablet once daily for 14 days,TMC278 25mg tablet once daily for 14 days,TMC278 25mg tablet once daily for 28 days Receives: Drug: TMC278; Drug: Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of TMC278 25 mg once daily (q.d.) following a preceding 2-week treatment period with EFV 600 mg q.d., in healthy volunteers
Measured: 70-77 days
Secondary outcomes (3)
To evaluate the EFV inducing effect on TMC278 metabolism after EFV intake cessation, through comparison of TMC278 plasma concentrations with and without preceding EFV intake
Measured: 70-77 days
To evaluate EFV plasma concentrations over time after cessation of EFV intake
Measured: 70-77 days
To assess the safety (including vital signs and electrocardiogram [ECG] measurements, laboratory assessments, and incidence of overall AEs and tolerability) of TMC278 at a dose of 25 mg q.d administered alone and after switching from EFV over a period of
Measured: 70-77 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
- Responsible party
- Sponsor
- Investigators
- Tibotec, Inc. Clinical Trial, Study director, Tibotec, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268839
- Sponsor's protocol ID
- CR016984
- Other IDs
- TMC278HIV1001
- Status last verified
- Sep 2013
- First submitted
- 30 Dec 2010
- Last updated
- 4 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Trial to Explore the Pharmacokinetics, Safety and Tolerability of TMC278 25 mg Once Daily Following a 2-week Period Receiving Efavirenz, in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT01268839
- Acronym / sponsor ID
- CR016984
- Conditions
- HIV
- Keywords
- TMC278, rilpivirine, efavirenz, healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tibotec, IncIndustry (pharma, biotech, devices)
- Collaborators
- Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 31 Dec 2010 (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 investigate the pharmacokinetics of TMC278 (rilpivirine) 25 mg once daily following a preceding 2-week treatment period with efavirenz 600 mg once daily in healthy volunteers
Detailed description
This is a Phase I, open-label (all people involved know the identity of the intervention), single center trial in healthy HIV negative volunteers to investigate the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body, the rate at which a drug action begins, the duration of the effect, the chemical changes of the substance in the body, and the effects and routes of excretion of the metabolites) of the drug of rilpivirine (TMC278) 25 mg once daily (q.d.). An approximate total of 20 volunteers will be enrolled in this trial. All volunteers will receive 3 different treatments; o Treatment A: TMC278 25 mg q.d. administered for 14 days.; o Treatment B: efavirenz (EFV) 600 mg q.d. administered for 14 days.; o Treatment C: TMC278 25 mg q.d. administered for 28 days (4 weeks).; All volunteers will start with Treatment A followed by Treatment B. Treatments A and B will be separated by a washout period of at least 14 days but no more than 21 days. At the end of Treatment B, volunteers will continue with Treatment C. There will be no washout period between Treatments B and C.; Full pharmacokinetic profiles of TMC278 will be determined up to 24 hours postdose on Days 1 and 14 of Treatment A (references), Day 1 (immediately after cessation of EFV intake) of Treatment C (test), and on Days 14, 21, and 28 (2, 3, and 4 weeks after cessation of EFV intake, respectively) of Treatment C. Trough (C0h) samples for determination of TMC278 plasma; concentrations will be collected regularly in between. Blood samples for determination of EFV plasma concentrations will be collected at regular time points during Treatment B and during Treatment C after cessation of EFV intake.; Serum samples for potential future testing of ex vivo antiviral activity will be collected and stored.; A pharmacogenomic blood sample for potential future CYP2B6 genotyping will be collected and stored from subjects who consent separately to the pharmacogenomic component of the trial.; Safety and tolerability will be evaluated throughout the trial. Rilpivirine (TMC278) 25mg once daily for 14 days, No Treatment 14-21 days, Efavirenz 600mg once daily for 14 days, TMC278 25mg once daily for 28 days
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: TMC278, Drug: EfavirenzEfavirenz 600mg tablet once daily for 14 days,TMC278 25mg tablet once daily for 14 days,TMC278 25mg tablet once daily for 28 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-vasectomized heterosexually active male volunteers with female partner of childbearing potential must be using a highly effective method of birth control (i.e., male condom with either female intrauterine device, diaphragm, cervical cap or hormonal based contraceptives) and must agree to use these birth control methods during the trial and until 30 days after the end of the trial
- Able to comply with all protocol requirements
- Normal resting ECG at screening including
- Volunteers must have signed an Informed Consent Form (ICF) voluntarily before the first trial-related activity indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial
- To participate in the optional pharmacogenomic component of this trial, volunteers must have signed the ICF for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the trial. Refusal to give consent for this component does not exclude a volunteers from participation in the clinical trial
Key exclusion criteria (7 listed)
- A positive HIV-1 or -2 test at trial screening
- Females of childbearing potential
- Hepatitis A infection (confirmed by hepatitis A antibody IgM), hepatitis B infection (confirmed by hepatitis B surface antigen), or hepatitis C infection (confirmed by hepatitis C virus antibody) diagnosed at trial screening
- Currently active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings during screening of medical history, laboratory or physical examination that in the investigator's opinion would compromise subject safety or the outcome of the trial
- Current or recent (within 3 months prior to the first administration of trial medication) gastrointestinal disease
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 |
|---|---|---|
| TMC27825mg tablet once daily for 28 days | Drug | 001 |
| TMC27825mg tablet once daily for 14 days | Drug | 001 |
| Efavirenz600mg tablet once daily for 14 days | Drug | 001 |
Primary outcome
Pharmacokinetics of TMC278 25 mg once daily (q.d.) following a preceding 2-week treatment period with EFV 600 mg q.d., in healthy volunteers
Time frame: 70-77 days
3 secondary outcomes
To evaluate the EFV inducing effect on TMC278 metabolism after EFV intake cessation, through comparison of TMC278 plasma concentrations with and without preceding EFV intake
Time frame: 70-77 days
To evaluate EFV plasma concentrations over time after cessation of EFV intake
Time frame: 70-77 days
To assess the safety (including vital signs and electrocardiogram [ECG] measurements, laboratory assessments, and incidence of overall AEs and tolerability) of TMC278 at a dose of 25 mg q.d administered alone and after switching from EFV over a period of
Time frame: 70-77 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 4 Sep 2013.
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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.
Tibotec, Inc. Clinical Trial study director
Tibotec, Inc
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TMC278 and Efavirenz in people with HIV, run by Tibotec, Inc.
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 6 inclusion and 7 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 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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 TMC278 25 mg once daily (q.d.) following a preceding 2-week treatment period with EFV 600 mg q.d., in healthy volunteers (time frame: 70-77 days). 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 4 Sep 2013.