A Study on the Interaction Between Danoprevir/Ritonavir and Methadone

Investigation of the Effect of Multiple Doses of Danoprevir/Ritonavir on Methadone in Subjects on Stable Methadone Maintenance Therapy (MMT)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01389544

Enrollment

Registered

2011-07-08

Start date

2011-06-30

Completion date

2011-07-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGdanoprevir

200 mg daily (100 mg q12h) orally, Days 1-10

DRUGmethadone

stable maintenance therapy: 20-120 mg daily single oral morning dose

DRUGritonavir

200 mg daily (100 mg q12h) orally, Days 1-10

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone	10 days

Secondary

Measure	Time frame
Safety: Incidence of adverse events	approximately 4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026