Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance
- Registration Number
- NCT01210404
- Lead Sponsor
- Pfizer
- Brief Summary
Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Males or females, without evidence of infection with HIV,HBV or HCV, who are on chronic methadone maintenance for at least three months and at a stable dose for at least 1 week prior to study start.
Exclusion Criteria
- Evidence of chronic diseases including HIV, HBV or HCV.
- Evidence of acute or chronic liver disease.
- Treatment with prescription or nonprescription drugs other than methadone within 7 days.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1.0 filibuvir -
- Primary Outcome Measures
Name Time Method Methadone plasma pharmacokinetic parameters, AUC24, Cmax day 11
- Secondary Outcome Measures
Name Time Method Methadone plasma pharmacokinetic parameters Tmax and C24h day 11 Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax. day 11 Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments. days 0-12 Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement . days 0-12
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Overland Park, Kansas, United States