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Completed

NCT Number: NCT01210404

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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Overland Park, Kansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

filibuvir

Drug

Filibuvir, 600mg bid administered along with methadone on days 2-11

Primary outcomes

  1. Methadone plasma pharmacokinetic parameters, AUC24, Cmax

    Time frame: day 1

  2. Methadone plasma pharmacokinetic parameters, AUC24, Cmax

    Time frame: day 11

Secondary outcomes

  1. Methadone plasma pharmacokinetic parameters Tmax and C24h

    Time frame: day 1

  2. Methadone plasma pharmacokinetic parameters Tmax and C24h

    Time frame: day 11

  3. Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.

    Time frame: day 2

  4. Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.

    Time frame: day 11

  5. Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments.

    Time frame: days 0-12

  6. Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement .

    Time frame: days 0-12

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 28, 2010
Registry last updated
Jun 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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