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Sponsors and Collaborators: |
Tibotec Pharmaceuticals Limited, Ireland Vertex Pharmaceuticals Inc. |
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Information provided by: | Tibotec Pharmaceuticals Limited, Ireland |
ClinicalTrials.gov Identifier: | NCT00933283 |
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.
Condition | Intervention | Phase |
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Hepatitis C |
Drug: telaprevir; methadone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Pharmacokinetics 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 Telaprevir 750 mg Every 8 Hours and Methadone, at Steady-state |
Estimated Enrollment: | 16 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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
Exclusion Criteria:
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email | info1@veritasmedicine.com |
Study Director: | Tibotec Pharmaceuticals Limited Clinical Trial | Tibotec Pharmaceutical Limited |
Responsible Party: | Tibotec Pharmaceuticals Limited, Ireland ( Senior Director Compound Development Team Leader ) |
Study ID Numbers: | CR015931 |
Study First Received: | July 2, 2009 |
Last Updated: | September 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00933283 History of Changes |
Health Authority: | Ireland: Irish Agriculture and Food Development Authority |
VX-950-TiDP24-C135 VX-950-C135 VX-950 HCV |
drug-drug interaction Methadone Telaprevir |
Liver Diseases Hepatitis, Viral, Human Central Nervous System Depressants Narcotics Hepatitis Virus Diseases Naphazoline Methadone |
Digestive System Diseases Guaifenesin Peripheral Nervous System Agents Hepatitis C Phenylpropanolamine Analgesics Analgesics, Opioid |
Respiratory System Agents Liver Diseases RNA Virus Infections Flaviviridae Infections Physiological Effects of Drugs Central Nervous System Depressants Hepatitis, Viral, Human Narcotics Pharmacologic Actions Hepatitis Virus Diseases |
Methadone Digestive System Diseases Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Hepatitis C Antitussive Agents Central Nervous System Agents Analgesics, Opioid |