A Study on the Interaction Between Danoprevir/Ritonavir and Methadone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01389544
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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 : June 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

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

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

Secondary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: approximately 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01389544

United States, California
Anaheim, California, United States, 92801
United States, Kansas
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01389544     History of Changes
Other Study ID Numbers: NP25644
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Anti-Bacterial Agents