A Study on the Interaction Between Danoprevir/Ritonavir and Methadone
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT01389544
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm danoprevir - Single Arm ritonavir - Single Arm methadone -
- Primary Outcome Measures
Name Time Method Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone 10 days
- Secondary Outcome Measures
Name Time Method Safety: Incidence of adverse events approximately 4 weeks