A Study on the Interaction Between Danoprevir/Ritonavir and Methadone

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01389544
• Collaborator: (none)
• Enrollment: 18
• Locations: 2
• Arm: 1
• Duration (Days): 30
• Patients Per Site: 9
• Patients Per Site Per Month: 9.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: danoprevir; Drug: methadone; Drug: ritonavir	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Investigation of the Effect of Multiple Doses of Danoprevir/Ritonavir on Methadone in Subjects on Stable Methadone Maintenance Therapy (MMT)
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm	Drug: danoprevir; 200 mg daily (100 mg q12h) orally, Days 1-10; Drug: methadone; stable maintenance therapy: 20-120 mg daily single oral morning dose; Drug: ritonavir; 200 mg daily (100 mg q12h) orally, Days 1-10

Outcome Measures

Primary Outcome Measures

1. Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone [10 days]

Secondary Outcome Measures

1. Safety: Incidence of adverse events [approximately 4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Anaheim	California	United States	92801
2		Overland Park	Kansas	United States	66211

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01389544
• Other Study ID Numbers: NP25644
• First Posted: Jul 8, 2011
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Ritonavir; Methadone

Study Results

No Results Posted as of Nov 2, 2016