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

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NCT01210404

Last updated on November 13, 2019
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Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66211 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Hepatitis C
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01210404
Pfizer
Completed
Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance

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Descriptive Information
Brief Title  ICMJE Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance
Official Title  ICMJE 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
Brief SummaryFilibuvir, 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE Drug: filibuvir
Filibuvir, 600mg bid administered along with methadone on days 2-11
Study Arms  ICMJE Experimental: 1.0
Intervention: Drug: filibuvir
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2010)		12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion DateMay 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01210404
Other Study ID Numbers  ICMJE A8121023
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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