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
• 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

• Chronic Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

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

External Links

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