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NCT01210404 Clinical Trial

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

Chronic Hepatitis C Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01210404
Other study ID # A8121023
Secondary ID
Status Completed
Phase Phase 1
First received September 27, 2010
Last updated June 6, 2011
Start date February 2011
Est. completion date June 2011

Study information
Verified date June 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date June 2011
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• filibuvir
Filibuvir, 600mg bid administered along with methadone on days 2-11

Locations
Country Name City State
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Overland Park Kansas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Methadone plasma pharmacokinetic parameters, AUC24, Cmax day 1 No
Primary Methadone plasma pharmacokinetic parameters, AUC24, Cmax day 11 No
Secondary Methadone plasma pharmacokinetic parameters Tmax and C24h day 1 No
Secondary Methadone plasma pharmacokinetic parameters Tmax and C24h day 11 No
Secondary Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax. day 2 No
Secondary Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax. day 11 No
Secondary Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments. days 0-12 Yes
Secondary Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement . days 0-12 Yes
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