A Study on the Interaction Between Danoprevir/Ritonavir and Methadone

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT01389544

Run by

Hoffmann-La Roche

People needed

18

Starts

2011-06-01

Expected to finish

2011-07-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Anaheim, California, United States
• Study site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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