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Completed

NCT Number: NCT01389544

A Study on the Interaction Between Danoprevir/Ritonavir and Methadone

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danoprevir

Drug

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

Methadone

Drug

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

Ritonavir

Drug

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

Primary outcomes

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

    Time frame: 10 days

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 4 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 8, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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