A Study on the Interaction Between Danoprevir/Ritonavir and Methadone
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 8/3/2016 |
Start Date: | June 2011 |
End Date: | July 2011 |
Investigation of the Effect of Multiple Doses of Danoprevir/Ritonavir on Methadone in Subjects on Stable Methadone Maintenance Therapy (MMT)
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.
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.
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
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