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A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir

NCT ID: NCT01592305

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

2012-05-31

Study Completion Date

2012-06-30

Brief Summary

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This randomized, open-label, multiple-treatment multiple-dose, 2-period, 2-sequence study will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in healthy volunteers. Subjects will be randomized to receive in Period 1 either single oral doses of TDF and multiple oral doses of DNV/r or multiple oral doses of ATZ/r. In Period 2, all subjects will receive multiple oral doses of DNV/r plus ATZ. Anticipated time on study treatment is up to 20 days.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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S1 P1 TDF + DNV/r

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

multiple oral doses

ritonavir

Intervention Type DRUG

multiple oral doses

tenofovir disoproxil fumarate

Intervention Type DRUG

single oral doses

S1/S2 P2 DNV/r + ATZ

Group Type EXPERIMENTAL

atazanavir

Intervention Type DRUG

multiple oral doses

danoprevir

Intervention Type DRUG

multiple oral doses

ritonavir

Intervention Type DRUG

multiple oral doses

S2 P1 ATZ/r

Group Type EXPERIMENTAL

atazanavir

Intervention Type DRUG

multiple oral doses

ritonavir

Intervention Type DRUG

multiple oral doses

Interventions

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atazanavir

multiple oral doses

Intervention Type DRUG

danoprevir

multiple oral doses

Intervention Type DRUG

ritonavir

multiple oral doses

Intervention Type DRUG

tenofovir disoproxil fumarate

single oral doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female volunteers, 18 to 55 years of age, inclusive
* Body weight \>/= 55 kg
* Body mass index (BMI) 18.0 - 32.0 kg/m2
* Healthy non-smoking subjects. 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
* Females of childbearing potential and males and their female partners of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last drug administration

Exclusion Criteria

* Pregnant or lactating women or males with female partners who are pregnant or lactating
* Any history of clinically significant disease or condition
* Positive for drugs of abuse at screening or prior to admission to the clinical site
* 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 an 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 allergy reaction
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
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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NP28104

Identifier Type: -

Identifier Source: org_study_id