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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01210404
First received: September 27, 2010
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: filibuvir
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Methadone plasma pharmacokinetic parameters, AUC24, Cmax [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Methadone plasma pharmacokinetic parameters, AUC24, Cmax [ Time Frame: day 11 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Methadone plasma pharmacokinetic parameters Tmax and C24h [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Methadone plasma pharmacokinetic parameters Tmax and C24h [ Time Frame: day 11 ] [ Designated as safety issue: No ]
  • Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax. [ Time Frame: day 2 ] [ Designated as safety issue: No ]
  • Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax. [ Time Frame: day 11 ] [ Designated as safety issue: No ]
  • Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments. [ Time Frame: days 0-12 ] [ Designated as safety issue: Yes ]
  • Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement . [ Time Frame: days 0-12 ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.0 Drug: filibuvir
Filibuvir, 600mg bid administered along with methadone on days 2-11

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210404

Locations
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01210404     History of Changes
Other Study ID Numbers: A8121023
Study First Received: September 27, 2010
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Drug interaction with methadone.

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 28, 2014