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A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir in Healthy Volunteers

NCT ID: NCT01588002

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-06-30

Brief Summary

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This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period 2, all subjects will receive multiple oral doses of the combination danoprevir with ritonavir and efavirenz for 14 days. Anticipated time on study treatment is 28 days.

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

NONE

Study Groups

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A danoprevir+ritonavir

Group Type ACTIVE_COMPARATOR

danoprevir

Intervention Type DRUG

multiple oral doses

ritonavir

Intervention Type DRUG

multiple oral doses

B efavirenz

Group Type ACTIVE_COMPARATOR

efavirenz

Intervention Type DRUG

multiple oral doses

C combination

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

multiple oral doses

efavirenz

Intervention Type DRUG

multiple oral doses

ritonavir

Intervention Type DRUG

multiple oral doses

Interventions

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danoprevir

multiple oral doses

Intervention Type DRUG

efavirenz

multiple oral doses

Intervention Type DRUG

ritonavir

multiple oral doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female non-smoking subjects, 18 to 55 years of age
* Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
* Medical history without major, recent or ongoing pathology
* Weight \>/= 50.0 kg
* Body mass index (BMI) 18.0 - 32.0 kg/m2

Exclusion Criteria

* Pregnant or lactating women or males with female partners who are pregnant or lactating
* History of any clinically significant medical condition which may impact the safety of the participant
* Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
* Positive for hepatitis B, hepatitis C or HIV infection
* Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
* Use of hormonal contraceptives (e.g. birth control pill, patches, or injectable, implantable devices) within 30 days before the first dose of study medication
* Use of investigational drug or device within 30 days of the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
* History of drug-related allergic reaction
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average; alcohol consumption will be prohibited 72 hours prior to entry in the clinical site center and throughout the entire study
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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Lenexa, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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NP28103

Identifier Type: -

Identifier Source: org_study_id