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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


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


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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