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OpenTrials
Completed

NCT Number: NCT01398293

A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects

This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Strasbourg, 67064, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult healthy volunteers, 18 - 60 years of age
  • Female subjects must be surgically sterile or post-menopausal
  • Male subjects and their partners of child-bearing potential must use to methods of contraception for the duration of the study and for three months after the last drug administration
  • Agree to abstain from strenuous exercise for three days before dosing and throughout the study (including washout period and follow-up visit)

Exclusion criteria

  • History or evidence of any clinically significant disease or disorder
  • Pregnant or lactating women
  • Male partners of women who are lactating or trying to become pregnant
  • Current smokers or subjects who have discontinued smoking less than six months prior to first dosing
  • Positive alcohol breath test; suspicion of regular consumption of drugs of abuse
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Participation in an investigational drug, biologic, or device study within three months before first study drug administration

Treatment and study plan

Danoprevir

Drug

100 mg single dose orally

danoprevir placebo

Drug

single oral dose

moxifloxacin

Drug

400 mg single dose orally

Moxifloxacin Placebo

Drug

single oral dose

Ritonavir

Drug

100 mg single dose orally

ritonavir placebo

Drug

single oral dose

Primary outcomes

  1. Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose

    Time frame: approximately 9 weeks

Secondary outcomes

  1. Pharmacokinetics: Plasma concentrations

    Time frame: approximately 9 weeks

  2. Safety: Incidence of adverse events

    Time frame: approximately 9 weeks

  3. Cardiac response: Electrocardiogram (ECG)

    Time frame: approximately 9 weeks

  4. Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes

    Time frame: approximately 9 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single-center, Single-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Four-way Crossover Study to Investigate the Effect of Danoprevir With Low Dose Ritonavir (DNV/r) on the QT/QTc Interval in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 20, 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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