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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pegylated Interferon and Ribavirin in Hepatitis C Patients on Opioid Pharmacotherapy

NCT01120795

Chronic Hepatitis C

COMPLETED PHASE4

Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

NCT03490097

Chronic Hepatitis c Metabolic Syndrome

COMPLETED PHASE2/PHASE3

Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy

NCT00682591

Chronic Hepatitis C Infection

WITHDRAWN

Hepatitis C in a Cohort of Patients With Maintenance Therapy for Opiate Dependence - Prevalence, Severity and Outcome of Antiviral Therapy

NCT01045278

Hepatitis C

COMPLETED PHASE4

Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1

NCT00218556

Depressive Disorder, Major Hepatitis C

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatitis C

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1.0

Group Type EXPERIMENTAL

filibuvir

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

filibuvir

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes