Back to resultsDrug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
filibuvir
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Drug interaction with methadone.
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1.0
Arm Description
Outcomes
Primary Outcome Measures
Methadone plasma pharmacokinetic parameters, AUC24, Cmax
Methadone plasma pharmacokinetic parameters, AUC24, Cmax
Secondary Outcome Measures
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 .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01210404
Brief Title
Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Drug interaction with methadone.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1.0
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
filibuvir
Intervention Description
Filibuvir, 600mg bid administered along with methadone on days 2-11
Primary Outcome Measure Information:
Title
Methadone plasma pharmacokinetic parameters, AUC24, Cmax
Time Frame
day 1
Title
Methadone plasma pharmacokinetic parameters, AUC24, Cmax
Time Frame
day 11
Secondary Outcome Measure Information:
Title
Methadone plasma pharmacokinetic parameters Tmax and C24h
Time Frame
day 1
Title
Methadone plasma pharmacokinetic parameters Tmax and C24h
Time Frame
day 11
Title
Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.
Time Frame
day 2
Title
Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.
Time Frame
day 11
Title
Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments.
Time Frame
days 0-12
Title
Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement .
Time Frame
days 0-12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8121023&StudyName=Drug%20Interaction%20Study%20Of%20Filibuvir%20With%20Methadone%20Among%20Subjects%20On%20Chronic%20Methadone%20Maintenance
Description
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Learn more about this trial
Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance
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