Drug-drug Interaction Trial Between Telaprevir and Methadone
Information source: Tibotec Pharmaceuticals, Ireland
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C
Intervention: telaprevir; methadone (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Tibotec Pharmaceuticals, Ireland Official(s) and/or principal investigator(s):
Tibotec Pharmaceuticals Limited Clinical Trial, Study Director, Affiliation: Tibotec Pharmaceutical Limited
Overall contact:
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com
Summary
The purpose of this study is to evaluate the effect of telaprevir on the pharmacokinetics of
methadone. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed
in the body and eliminated from the body. Telaprevir is being investigated for the treatment
of chronic hepatitis C virus infection.
Clinical Details
Official title: VX-950-TiDP24-C134: A Phase I, Open-label, Single-sequence Drug-drug Interaction Trial in Subjects on Stable Methadone Maintenance Therapy, to Investigate the Potential Interaction Between Telaprevir 750 mg Every 8 Hours and Methadone, at Steady-state
Study design: Treatment, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: To evaluate the effect of steady-state TVR 750 mg every 8hr on the steady-state pharmacokinetics of R- and S-methadone (2 forms of methadone which have a different structure).
Secondary outcome: The potential effect of TVR on the pharmacodynamic effects of methadone therapy will be evaluated.The short-term safety and tolerability of coadministration of TVR and methadone on stable methadone maintenance therapy will be evaluated.
Detailed description:
This is a Phase I, open-label (both participant and investigator know the name of the
assigned medication), single-sequence (all participants receive treatments in the same
order) drug-drug interaction trial for participants on stable methadone maintenance therapy,
to investigate the potential interaction between telaprevir (TVR) 750 mg every 8 hours and
methadone. The trial population will consist of 16 participants on stable methadone
maintenance therapy. Participants will receive TVR 750 mg every 8 hours for 7 days added to
their current methadone therapy. The current methadone dosage for the participants is not to
be changed from screening until Day 7 inclusive, unless warranted by investigator's
assessment of the safety of the participant. During 24 hours, several blood samples will be
taken to determine the pharmacokinetic profiles of methadone on the day before starting TVR
(while taking methadone alone) and on Day 7 (taking methadone + TVR). On Day 7 (taking
methadone + TVR), several blood samples will be taken during 8 hours to determine the
pharmacokinetic profile of TVR. The potential effect of TVR on the pharmacodynamic effects
(what the drug does to the body) of methadone therapy will be evaluated. The 'Short Opiate
Withdrawal scale' and the 'Desires for Drugs Questionnaire' will have to be completed 10
times throughout the study by the patients. Also the diameter of the pupil of the eye will
be measured 14 times during the study as changes to the size of the pupils could indicate
that TVR increases or decreases the levels of methadone in the blood. Safety and
tolerability of coadministration of TVR and methadone will be evaluated. Safety blood
samples will be taken at screening, 14 days before starting TVR, the day before starting
TVR, day 1, day 3, day 5, day 7, day 8 and at the 2 follow-up visits. A urine sample will be
collected at screening, 14 and 7 days before starting TVR, daily from 4 days before starting
TVR to day 8 and at the 2 follow-up visits. 3 ECG's (a painless tracing of the electrical
activity of the heart) will be recorded at screening, twice on the day before starting TVR,
day 1, day 3, day 5, twice on day 7, day 8 and at the first follow-up visit. Vital signs
will be taken at screening, 14 days before starting TVR, 3 times on the day before starting
TVR, day 1, twice on day 2, day 3, twice on day 4, day 5, 3 times on day 7, day 8 and at the
2 follow-up visits. Illnesses and side effects will be checked from screening until the last
trial related visit. A physical examination will be done at screening, 2 days before
starting TVR, day 1, day 6 and at the 2 follow-up visits. An alcohol breath test will be
done at screening and at 2 days before starting TVR. TVR will be given from day 1 to day 7,
every 8 hours as 2 oral tablets. Methadone will be provided as a commercially available
formulation (oral tablets or solution) at an individualized dose between 30 and 130 mg
daily.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Receiving once daily oral methadone maintenance therapy at a stable individualized
dose of 30 to 130 mg for at least 2 weeks prior to screening, formulated as
commercially available tablets or solution
- Agreement not to change the current methadone dose from screening until Day 7
included and to have a daily observed and documented methadone intake from 14 days
before starting TVR until Day 8, and a daily observed and documented TVR intake from
Day 1 until Day 7
- A body mass index (BMI) of 18. 0 to 30. 0 kg/m2, extremes included
- Otherwise healthy on the basis of a physical examination, medical history (except
drug abuse), electrocardiogram (ECG), vital signs and the results of laboratory tests
and a urinalysis carried out at screening
Exclusion Criteria:
- Test positive for drugs of abuse such as cocaine, amphetamines, barbiturates, benzodiazepines, or opiates on Day - 2 unless explained by allowed concomitant
medications
- Participation in a clinical study involving administration of an investigational drug
within 60 days or 5 half lives (whichever is longer) prior to the screening visit
- Male participants with female partners that are planning to become pregnant during
the study or within 90 days of the last dose of TVR
- Current alcohol use, which, in the assessment of the investigator, could compromise
participant's safety or compliance with the study protocol procedures
Locations and Contacts
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com Additional Information
Ending date: November 2009
Last updated: September 25, 2009
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