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: October 6, 2014
Last verified: October 2014
  Purpose

This single-dose, randomized, double-blind, double-dummy, placebo-controlled, po sitive-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 vol unteers. Subjects will be randomly assigned to one of four sequences with treatm ents of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherap eutic 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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ 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: 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

  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
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: 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: October 6, 2014
Health Authority: France: Afssaps - Fench Health Products Safety Agency

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

ClinicalTrials.gov processed this record on October 29, 2014