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

NCT ID: NCT01398293

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

100 mg single dose orally

moxifloxacin placebo

Intervention Type DRUG

single oral dose

ritonavir

Intervention Type DRUG

100 mg single dose orally

B

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

400 mg single dose orally

moxifloxacin placebo

Intervention Type DRUG

single oral dose

ritonavir

Intervention Type DRUG

100 mg single dose orally

C

Group Type ACTIVE_COMPARATOR

danoprevir placebo

Intervention Type DRUG

single oral dose

moxifloxacin

Intervention Type DRUG

400 mg single dose orally

ritonavir placebo

Intervention Type DRUG

single oral dose

D

Group Type PLACEBO_COMPARATOR

danoprevir placebo

Intervention Type DRUG

single oral dose

moxifloxacin placebo

Intervention Type DRUG

single oral dose

ritonavir placebo

Intervention Type DRUG

single oral dose

Interventions

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danoprevir

100 mg single dose orally

Intervention Type DRUG

danoprevir

400 mg single dose orally

Intervention Type DRUG

danoprevir placebo

single oral dose

Intervention Type DRUG

moxifloxacin

400 mg single dose orally

Intervention Type DRUG

moxifloxacin placebo

single oral dose

Intervention Type DRUG

ritonavir

100 mg single dose orally

Intervention Type DRUG

ritonavir placebo

single oral dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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2011-001413-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NP25298

Identifier Type: -

Identifier Source: org_study_id