Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance

Pfizer

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: filibuvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01210404

A8121023

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

1.0

Experimental group

Treatment:

Drug: filibuvir