A Study on the Interaction Between Danoprevir/Ritonavir and Methadone

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389544
• Other study ID #: NP25644
• Status: Completed
• Phase: Phase 1
• First received: July 6, 2011
• Last updated: November 1, 2016
• Start date: June 2011
• Est. completion date: July 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• danoprevir
200 mg daily (100 mg q12h) orally, Days 1-10
• methadone
stable maintenance therapy: 20-120 mg daily single oral morning dose
• ritonavir
200 mg daily (100 mg q12h) orally, Days 1-10

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone		10 days	No
Secondary	Safety: Incidence of adverse events		approximately 4 weeks	No