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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 19, 2011
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Healthy Volunteer Drug: danoprevir Drug: danoprevir placebo Drug: moxifloxacin Drug: moxifloxacin placebo Drug: ritonavir Drug: ritonavir placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Official 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose [ Time Frame: approximately 9 weeks ]

Secondary Outcome Measures:
  • Pharmacokinetics: Plasma concentrations [ Time Frame: approximately 9 weeks ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 9 weeks ]
  • Cardiac response: Electrocardiogram (ECG) [ Time Frame: approximately 9 weeks ]
  • Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes [ Time Frame: approximately 9 weeks ]

Enrollment: 52
Study Start Date: August 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: danoprevir
100 mg single dose orally
Drug: moxifloxacin placebo
single oral dose
Drug: ritonavir
100 mg single dose orally
Experimental: B Drug: danoprevir
400 mg single dose orally
Drug: moxifloxacin placebo
single oral dose
Drug: ritonavir
100 mg single dose orally
Active Comparator: C Drug: danoprevir placebo
single oral dose
Drug: moxifloxacin
400 mg single dose orally
Drug: ritonavir placebo
single oral dose
Placebo Comparator: D Drug: danoprevir placebo
single oral dose
Drug: moxifloxacin placebo
single oral dose
Drug: ritonavir placebo
single oral dose


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  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 identifier: NCT01398293

Strasbourg, France, 67064
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01398293     History of Changes
Other Study ID Numbers: NP25298
2011-001413-13 ( EudraCT Number )
Study First Received: July 19, 2011
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Norgestimate, ethinyl estradiol drug combination
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
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors processed this record on July 19, 2017