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

Pfizer12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C

Interventions

filibuvirDRUG

Filibuvir, 600mg bid administered along with methadone on days 2-11

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Pfizer Investigational Site

Overland Park, Kansas, United States

Pfizer Investigational Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Methadone plasma pharmacokinetic parameters, AUC24, Cmax

Time frame: day 1

Methadone plasma pharmacokinetic parameters, AUC24, Cmax

Time frame: day 11

Secondary Outcomes

Methadone plasma pharmacokinetic parameters Tmax and C24h

Time frame: day 1

Methadone plasma pharmacokinetic parameters Tmax and C24h

Time frame: day 11

Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.

Time frame: day 2

Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.

Time frame: day 11

Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments.

Time frame: days 0-12

Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement .

Time frame: days 0-12

Data from ClinicalTrials.gov

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