A Study on the Interaction Between Danoprevir/Ritonavir and Methadone
NCT ID: NCT01389544
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2011-06-30
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Single Arm
danoprevir
200 mg daily (100 mg q12h) orally, Days 1-10
methadone
stable maintenance therapy: 20-120 mg daily single oral morning dose
ritonavir
200 mg daily (100 mg q12h) orally, Days 1-10
Interventions
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danoprevir
200 mg daily (100 mg q12h) orally, Days 1-10
methadone
stable maintenance therapy: 20-120 mg daily single oral morning dose
ritonavir
200 mg daily (100 mg q12h) orally, Days 1-10
Eligibility Criteria
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Inclusion Criteria
* Subjects must be on a stable methadone maintenance regimen (20 to 120 mg/day) for the treatment of opiate addiction for at least 30 days prior to screening and should be on a stable dose for at least 14 days prior to Day -1
* Body weight \>/= 50 kg
* Body mass index (BMI) 18.0 - 32.0 kg/m2
* Females of childbearing potential and males with female partners of childbearing potential must agree to use 2 forms of non-hormonal contraception during the study and for 90 days after the last study drug administration
Exclusion Criteria
* Symptoms of methadone withdrawal at screening, on Day -2 or Day -1
* Inadequate venous access
* History or evidence of any clinically significant disease or disorder, except for drug abuse or dependence
* Positive test for alcohol or drugs of abuse at screening and up to Day -2 (with the exception of methadone)
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol); alcohol consumption will be prohibited during study confinement and for at least 48 hours before screening, dosing and each scheduled visit
* Positive for hepatitis B, hepatitis C or HIV infection
18 Years
65 Years
ALL
Yes
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Anaheim, California, United States
Overland Park, Kansas, United States
Countries
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Other Identifiers
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NP25644
Identifier Type: -
Identifier Source: org_study_id