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
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2011
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2010
CompletedFirst Posted
Study publicly available on registry
September 28, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 7, 2011
June 1, 2011
3 months
September 27, 2010
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Methadone plasma pharmacokinetic parameters, AUC24, Cmax
day 1
Methadone plasma pharmacokinetic parameters, AUC24, Cmax
day 11
Secondary Outcomes (6)
Methadone plasma pharmacokinetic parameters Tmax and C24h
day 1
Methadone plasma pharmacokinetic parameters Tmax and C24h
day 11
Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.
day 2
Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.
day 11
Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments.
days 0-12
- +1 more secondary outcomes
Study Arms (1)
1.0
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (2)
Pfizer Investigational Site
Overland Park, Kansas, 66211, United States
Pfizer Investigational Site
Overland Park, Kansas, 66212, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 27, 2010
First Posted
September 28, 2010
Study Start
February 1, 2011
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
June 7, 2011
Record last verified: 2011-06