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VX-950-TiDP24-C135: Drug-drug Interaction Trial Between Telaprevir and Methadone.
This study has been completed.

First Received on July 2, 2009.   Last Updated on December 16, 2010   History of Changes
Sponsor: Tibotec BVBA
Collaborator: Vertex Pharmaceuticals Incorporated
Information provided by: Tibotec BVBA
ClinicalTrials.gov Identifier: NCT00933283
  Purpose

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
Hepatitis C
Drug: telaprevir; methadone
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Tibotec BVBA:

Primary Outcome Measures:
  • 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). [ Time Frame: On the day before starting TVR and on day 7. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The potential effect of TVR on the pharmacodynamic effects of methadone therapy will be evaluated. [ Time Frame: The 'Short Opiate Withdrawal scale' and the 'Desires for Drugs Questionnaire' will have to be completed 10 times in a period of 14 days. Also the diameter of the pupil of the eye will be measured 14 times in a period of 14 days. ] [ Designated as safety issue: No ]
  • The short-term safety and tolerability of coadministration of TVR and methadone on stable methadone maintenance therapy will be evaluated. [ Time Frame: Safety and tolerability will be followed during 1 month. ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933283

Sponsors and Collaborators
Tibotec BVBA
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Tibotec-Virco Virology BVBA Clinical Trial Tibotec BVBA
  More Information

No publications provided

Responsible Party: Senior Director Compound Development Team Leader, Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00933283     History of Changes
Other Study ID Numbers: CR015931
Study First Received: July 2, 2009
Last Updated: December 16, 2010
Health Authority: USA: FOOD AND DRUG ADMINISTRATION - CENTER FOR DRUG EVALUATION AND RESEARCH

Keywords provided by Tibotec BVBA:
VX-950-TiDP24-C135
VX-950-C135
VX-950
HCV
drug-drug interaction
Methadone
Telaprevir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on May 24, 2012