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

Last updated on May 9, 2018

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Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66211 United States
Contact
1-800-718-1021
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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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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Hepatitis C
Drug: filibuvir
Filibuvir, 600mg bid administered along with methadone on days 2-11
Experimental: 1.0
Intervention: Drug: filibuvir
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2011
May 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01210404
A8121023
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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