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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: filibuvir (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

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

Primary outcome:

Methadone plasma pharmacokinetic parameters, AUC24, Cmax

Methadone plasma pharmacokinetic parameters, AUC24, Cmax

Secondary outcome:

Methadone plasma pharmacokinetic parameters Tmax and C24h

Methadone plasma pharmacokinetic parameters Tmax and C24h

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

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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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 and Contacts

Pfizer Investigational Site, Overland Park, Kansas 66211, United States

Pfizer Investigational Site, Overland Park, Kansas 66212, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: February 2011
Last updated: June 6, 2011

Page last updated: August 23, 2015

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