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

NCT01398293 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2016-11-02

No results posted yet for this study

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

Interventions

DRUG

danoprevir

100 mg single dose orally

DRUG

danoprevir

400 mg single dose orally

DRUG

danoprevir placebo

single oral dose

DRUG

moxifloxacin

400 mg single dose orally

DRUG

moxifloxacin placebo

single oral dose

DRUG

ritonavir

100 mg single dose orally

DRUG

ritonavir placebo

single oral dose

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01398293 on ClinicalTrials.gov