Drug Interaction Study Of Filibuvir With Methadone, Among Subjects On Chronic Methadone Maintenance
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis C
Intervention: filibuvir (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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, CmaxMethadone plasma pharmacokinetic parameters, AUC24, Cmax
Secondary outcome: Methadone plasma pharmacokinetic parameters Tmax and C24hMethadone 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 CT.gov Call Center, Phone: 1-800-718-1021 Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2010
Last updated: September 27, 2010
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