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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01398293
First received: July 19, 2011
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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: ritonavir
Drug: moxifloxacin
Drug: danoprevir placebo
Drug: ritonavir placebo
Drug: moxifloxacin placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Plasma concentrations [ Time Frame: approximately 9 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 9 weeks ] [ Designated as safety issue: No ]
  • Cardiac response: Electrocardiogram (ECG) [ Time Frame: approximately 9 weeks ] [ Designated as safety issue: No ]
  • Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes [ Time Frame: approximately 9 weeks ] [ Designated as safety issue: No ]

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: ritonavir
100 mg single dose orally
Drug: moxifloxacin placebo
single oral dose
Experimental: B Drug: danoprevir
400 mg single dose orally
Drug: ritonavir
100 mg single dose orally
Drug: moxifloxacin placebo
single oral dose
Active Comparator: C Drug: moxifloxacin
400 mg single dose orally
Drug: danoprevir placebo
single oral dose
Drug: ritonavir placebo
single oral dose
Placebo Comparator: D Drug: danoprevir placebo
single oral dose
Drug: ritonavir placebo
single oral dose
Drug: moxifloxacin placebo
single oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398293

Locations
France
Strasbourg, France, 67064
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: NCT01398293     History of Changes
Other Study ID Numbers: NP25298, 2011-001413-13
Study First Received: July 19, 2011
Last Updated: May 23, 2013
Health Authority: France: Afssaps - Fench Health Products Safety Agency

Additional relevant MeSH terms:
Ritonavir
Moxifloxacin
Lactams
Norgestimate, ethinyl estradiol drug combination
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
 Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013