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

Open Label Single Sequence Study To Estimate The Effect Of Filibuvir (PF-00868554) On S-And R-Methadone In Subjects Receiving Chronic Methadone Treatment And To Evaluate The Pharmacokinetics Of Filibuvir

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01210404

Enrollment

Registered

2010-09-28

Start date

2011-02-28

Completion date

2011-06-30

Last updated

2011-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Drug interaction with methadone.

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.

Interventions

DRUGfilibuvir

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Methadone plasma pharmacokinetic parameters, AUC24, Cmax	day 1

Secondary

Measure	Time frame
Methadone plasma pharmacokinetic parameters Tmax and C24h	day 1
Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.	day 2
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026