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

NCT01398293 | Completed Phase 1

• 2 other identifiers: NP252982011-001413-13
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

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

  approximately 9 weeks

Secondary Outcomes (4)

• Pharmacokinetics: Plasma concentrations

  approximately 9 weeks

• Safety: Incidence of adverse events

  approximately 9 weeks

• Cardiac response: Electrocardiogram (ECG)

  approximately 9 weeks

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

  approximately 9 weeks

Study Arms (4)

A

EXPERIMENTAL

Drug: danoprevir; Drug: moxifloxacin placebo; Drug: ritonavir

B

EXPERIMENTAL

Drug: danoprevir; Drug: moxifloxacin placebo; Drug: ritonavir

C

ACTIVE COMPARATOR

Drug: danoprevir placebo; Drug: moxifloxacin; Drug: ritonavir placebo

D

PLACEBO COMPARATOR

Drug: danoprevir placebo; Drug: moxifloxacin placebo; Drug: ritonavir placebo

Interventions

danoprevir DRUG

100 mg single dose orally

A

danoprevir placebo DRUG

single oral dose

C; D

moxifloxacin DRUG

400 mg single dose orally

C

moxifloxacin placebo DRUG

single oral dose

A; B; D

ritonavir DRUG

100 mg single dose orally

A; B

ritonavir placebo DRUG

single oral dose

C; D

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Strasbourg, 67064, France

Location

MeSH Terms

Interventions

danoprevir; Moxifloxacin; Ritonavir

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 20, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (1)