A Study on the Interaction Between Danoprevir/Ritonavir and Methadone
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer
Intervention: danoprevir (Drug); methadone (Drug); ritonavir (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
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.
Clinical Details
Official title: Investigation of the Effect of Multiple Doses of Danoprevir/Ritonavir on Methadone in Subjects on Stable Methadone Maintenance Therapy (MMT)
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone
Secondary outcome: Safety: Incidence of adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Anaheim, California 92801, United States
Overland Park, Kansas 66211, United States
Additional Information
Starting date: June 2011
Last updated: August 17, 2015
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