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A Study on the Interaction Between Danoprevir/Ritonavir and Methadone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01389544
First received: July 6, 2011
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This multicenter, open-label study will assess the effect of multiple doses of d anoprevir/ritonavir on steady-state pharmacokinetics of methadone. Subjects on s table methadone maintenance therapy (20 - 120 mg daily as single oral morning do se) will receive danoprevir 100 mg orally twice daily and ritonavir 100 mg orall y twice daily for 10 days.


Condition Intervention Phase
Healthy Volunteer
Drug: danoprevir
Drug: methadone
Drug: ritonavir
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Investigation of the Effect of Multiple Doses of Danoprevir/Ritonavir on Methadone in Subjects on Stable Methadone Maintenance Therapy (MMT)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: June 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389544

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01389544     History of Changes
Other Study ID Numbers: NP25644
Study First Received: July 6, 2011
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Methadone
Ritonavir
Analgesics
Analgesics, Opioid
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antitussive Agents
Antiviral Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014