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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398293
• Other study ID #: NP25298
• Secondary ID: 2011-001413-13
• Status: Completed
• Phase: Phase 1
• First received: July 19, 2011
• Last updated: November 1, 2016
• Start date: August 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Fench Health Products Safety Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• danoprevir
100 mg single dose orally
• danoprevir
400 mg single dose orally
• danoprevir placebo
single oral dose
• moxifloxacin
400 mg single dose orally
• moxifloxacin placebo
single oral dose
• ritonavir
100 mg single dose orally
• ritonavir placebo
single oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose		approximately 9 weeks	No
Secondary	Pharmacokinetics: Plasma concentrations		approximately 9 weeks	No
Secondary	Safety: Incidence of adverse events		approximately 9 weeks	No
Secondary	Cardiac response: Electrocardiogram (ECG)		approximately 9 weeks	No
Secondary	Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes		approximately 9 weeks	No