NCT01389544CompletedPhase 1
Investigation of the Effect of Multiple Doses of Danoprevir/Ritonavir on Methadone in Subjects on Stable Methadone Maintenance Therapy (MMT)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 18
- Primary Endpoint
- Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone
Study Overview
Brief Summary
This multicenter, open-label study will assess the effect of multiple doses of danoprevir/ritonavir on steady-state pharmacokinetics of methadone. Subjects on stable methadone maintenance therapy (20 - 120 mg daily as single oral morning dose) will receive danoprevir 100 mg orally twice daily and ritonavir 100 mg orally twice daily for 10 days.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male and female adults, 18 - 65 years of age, inclusive
- •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
- •Pregnant or lactating women and male partners of women who are pregnant or lactating
- •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
Arms & Interventions
Single Arm
Experimental
Intervention: danoprevir (Drug)
Single Arm
Experimental
Intervention: methadone (Drug)
Single Arm
Experimental
Intervention: ritonavir (Drug)
Outcomes
Primary Outcomes
Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone
Time Frame: 10 days
Secondary Outcomes
- Safety: Incidence of adverse events(approximately 4 weeks)
Investigators
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