A Study on the Interaction Between Danoprevir/Ritonavir and Methadone

NCT01389544 | Completed Phase 1

• 1 other identifier: NP25644
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone

  10 days

Secondary Outcomes (1)

• Safety: Incidence of adverse events

  approximately 4 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: danoprevir; Drug: methadone; Drug: ritonavir

Interventions

danoprevir DRUG

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

Single Arm

methadone DRUG

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

Single Arm

ritonavir DRUG

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

Single Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Interventions

danoprevir; Methadone; Ritonavir

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 8, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (2)