HIVPhase 1NCT00744770
TMC278-TiDP6-C121: Drug-drug Interaction Trial to Investigate the Potential Interaction Between TMC278 25 mg Daily and Methadone, at Steady State.
A Phase 1 study testing TMC278 in people with HIV, run by Tibotec Pharmaceuticals, Ireland.
Trial summary
The purpose of this Phase I, open-label, single-sequence drug-drug interaction trial in patients on stable methadone maintenance therapy is to investigate the potential interaction between TMC278 25 mg daily and methadone, at steady-state. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- TMC278
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Jun 2009
- 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
- Body Mass Index of 18.0 to 30.0 kg/m2, extremes included
- Receiving once daily oral methadone maintenance therapy at a stable individualized dose of 60 to 150 mg
- The patient agrees not to change the current methadone dose from screening until Day 11 included and to have a daily observed and documented methadone intake from Day -14 until Day 12, and a daily observed and documented TMC278 intake from Day 1 until Day 11
- Able to comply with protocol requirements
- The patient has obtained approval from his/her addiction physician for participation in this trial. Furthermore, the addiction physician agrees to provide medical care for the patient after discharge from the testing facility
- General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial
- Otherwise healthy on the basis of a physical examination, medical history (except drug abuse), ECG, vital signs and the results of blood biochemistry and hematology tests and a urinalysis carried out at screening.
Who cannot join
- A positive test for HIV-1, HIV-2, hepatitis A virus or hepatitis B virus
- female of child bearing potential
- evidence of current use of illicit drugs or opioids (with the exception of methadone) or abuse of alcohol
- impaired liver function as defined in the protocol
- other currently active or underlying disorders, including gastrointestinal, cardiovascular, neurologic, psychiatric (other than drug dependency), metabolic, adrenal, renal, hepatic, respiratory, inflammatory, or infectious disease
- presence of risk factors for QTc prolongation
Show all 10Show fewer
- any history of significant skin disease or allergies, including allergy or hypersensitivity to the excipients of the investigational medication TMC278 or to methadone
- Previous experience of clinically significant hypersensitivity to methadone hydrochloride
- Use of disallowed concomitant therapy during the 14 days prior to the first dose of TMC278
- recent donation of blood or plasma or participation in a clinical trial.
About this study
Official title: A Phase I, Open-label, Single-sequence Drug-drug Interaction Trial in Subjects on Stable Methadone Maintenance Therapy, to Investigate the Potential Interaction Between TMC278 25 mg q.d. and Methadone, at Steady-state.
The purpose of this Phase I, open-label, single-sequence drug-drug interaction trial in patients on stable methadone maintenance therapy is to investigate the potential interaction between TMC278 25 mg daily and methadone, at steady-state.
Read the detailed description
This is a Phase I, open-label, single-sequence drug-drug interaction trial in patients on stable methadone maintenance therapy, to investigate the potential interaction between TMC278 25 mg daily and methadone, at steady-state. TMC278 is under development for the treatment of HIV-1 infected patients. The trial population will consist of 16 HIV-negative patients on stable methadone maintenance therapy. Patients will receive TMC278 25 mg daily for 11 days, added to their current methadone therapy. The current methadone dosage for each patient is not to be changed from screening until Day 11 inclusive. Methadone dose will be individualized for each patient and should be between 60 and 150 mg daily. Full 24 hour pharmacokinetic profiles of R- and S-methadone will be determined on Day -1 (methadone alone) and on Day 11 (methadone + TMC278). A full 24 hour pharmacokinetic profile of TMC278 will be determined on Day 11 (methadone + TMC278). Pharmacodynamic assessments of the symptoms of methadone withdrawal (Short Opiate Withdrawal Scale (SOWS), Desires for Drugs Questionnaire (DDQ), pupillometry) will be performed on Day -7 and daily from Day -3 until Day 11, within 2 hours before the intake of methadone. Safety and tolerability will be evaluated continuously throughout the trial. Patients will receive TMC278 added to their current methadone therapy in the following way: methadone individualized maintenance therapy, 60 to 150 mg daily from Day -14 to 11 and TMC278 25 mg tablet by mouth daily from Day 1 to 11. TMC278 and methadone will both be taken within 10 minutes after completion of a breakfast.
- Conditions
- HIV
- Being tested
- TMC278
- Keywords
- TMC278-TiDP6-C121, TMC278-C121, open-label, drug-drug interaction, methadone, TMC278
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC278Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of steady-state TMC278 25 mg q.d. on the steady-state pharmacokinetics of R- and S-methadone after 11 days of TMC278 intake.
Secondary outcomes (1)
To evaluate after 11 days of TMC278 intake: the potential effect of TMC278 on the pharmacodynamic effects of methadone therapy; the steady-state pharmacokinetics of TMC278 25 mg daily; the short-term safety and tolerability of coadministration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tibotec Pharmaceuticals Limited Clinical Trial, Study director, Tibotec Pharmaceutical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744770
- Sponsor's protocol ID
- CR002524
- Status last verified
- Apr 2010
- First submitted
- 29 Aug 2008
- Last updated
- 28 Apr 2010
- Results posted
- No
Publications
Crauwels HM, van Heeswijk RP, Vandevoorde A, Buelens A, Stevens M, Hoetelmans RM. The effect of rilpivirine on the pharmacokinetics of methadone in HIV-negative volunteers. J Clin Pharmacol. 2014 Feb;54(2):133-40. doi: 10.1002/jcph.222. Epub 2013 Nov 23.
PubMed 24203510
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Single-sequence Drug-drug Interaction Trial in Subjects on Stable Methadone Maintenance Therapy, to Investigate the Potential Interaction Between TMC278 25 mg q.d. and Methadone, at Steady-state.
- ClinicalTrials.gov ID
- NCT00744770
- Acronym / sponsor ID
- CR002524
- Conditions
- HIV
- Keywords
- TMC278-TiDP6-C121, TMC278-C121, open-label, drug-drug interaction, methadone, TMC278
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 1 Sep 2008 (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 Phase I, open-label, single-sequence drug-drug interaction trial in patients on stable methadone maintenance therapy is to investigate the potential interaction between TMC278 25 mg daily and methadone, at steady-state.
Detailed description
This is a Phase I, open-label, single-sequence drug-drug interaction trial in patients on stable methadone maintenance therapy, to investigate the potential interaction between TMC278 25 mg daily and methadone, at steady-state. TMC278 is under development for the treatment of HIV-1 infected patients. The trial population will consist of 16 HIV-negative patients on stable methadone maintenance therapy. Patients will receive TMC278 25 mg daily for 11 days, added to their current methadone therapy. The current methadone dosage for each patient is not to be changed from screening until Day 11 inclusive. Methadone dose will be individualized for each patient and should be between 60 and 150 mg daily. Full 24 hour pharmacokinetic profiles of R- and S-methadone will be determined on Day -1 (methadone alone) and on Day 11 (methadone + TMC278). A full 24 hour pharmacokinetic profile of TMC278 will be determined on Day 11 (methadone + TMC278). Pharmacodynamic assessments of the symptoms of methadone withdrawal (Short Opiate Withdrawal Scale (SOWS), Desires for Drugs Questionnaire (DDQ), pupillometry) will be performed on Day -7 and daily from Day -3 until Day 11, within 2 hours before the intake of methadone. Safety and tolerability will be evaluated continuously throughout the trial. Patients will receive TMC278 added to their current methadone therapy in the following way: methadone individualized maintenance therapy, 60 to 150 mg daily from Day -14 to 11 and TMC278 25 mg tablet by mouth daily from Day 1 to 11. TMC278 and methadone will both be taken within 10 minutes after completion of a breakfast.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body Mass Index of 18.0 to 30.0 kg/m2, extremes included
- Receiving once daily oral methadone maintenance therapy at a stable individualized dose of 60 to 150 mg
- The patient agrees not to change the current methadone dose from screening until Day 11 included and to have a daily observed and documented methadone intake from Day -14 until Day 12, and a daily observed and documented TMC278 intake from Day 1 until Day 11
- Able to comply with protocol requirements
- The patient has obtained approval from his/her addiction physician for participation in this trial. Furthermore, the addiction physician agrees to provide medical care for the patient after discharge from the testing facility
Key exclusion criteria (10 listed)
- A positive test for HIV-1, HIV-2, hepatitis A virus or hepatitis B virus
- female of child bearing potential
- evidence of current use of illicit drugs or opioids (with the exception of methadone) or abuse of alcohol
- impaired liver function as defined in the protocol
- other currently active or underlying disorders, including gastrointestinal, cardiovascular, neurologic, psychiatric (other than drug dependency), metabolic, adrenal, renal, hepatic, respiratory, inflammatory, or infectious 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 |
|---|---|---|
| TMC278 | Drug | – |
Primary outcome
To evaluate the effect of steady-state TMC278 25 mg q.d. on the steady-state pharmacokinetics of R- and S-methadone after 11 days of TMC278 intake.
1 secondary outcome
To evaluate after 11 days of TMC278 intake: the potential effect of TMC278 on the pharmacodynamic effects of methadone therapy; the steady-state pharmacokinetics of TMC278 25 mg daily; the short-term safety and tolerability of coadministration.
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 Apr 2010.
- Derived from this study: PubMed 24203510Crauwels HM, van Heeswijk RP, Vandevoorde A, Buelens A, Stevens M, Hoetelmans RM. The effect of rilpivirine on the pharmacokinetics of methadone in HIV-negative volunteers. J Clin Pharmacol. 2014 Feb;54(2):133-40. doi: 10.1002/jcph.222. Epub 2013 Nov 23.
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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 Pharmaceuticals Limited Clinical Trial study director
Tibotec Pharmaceutical Limited
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TMC278 in people with HIV, run by Tibotec Pharmaceuticals, Ireland.
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 7 inclusion and 10 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 Apr 2010. 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?
To evaluate the effect of steady-state TMC278 25 mg q.d. on the steady-state pharmacokinetics of R- and S-methadone after 11 days of TMC278 intake.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00744770, which also lists 1 linked publication.
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 Apr 2010.