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A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers

NCT ID: NCT01519336

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

2012-02-29

Study Completion Date

2012-03-31

Brief Summary

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This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential drug-drug interactions between darunavir and danoprevir when administered together with low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to receive either darunavir or danoprevir together with low-dose ritonavir for 10 days. In Period 2, all subjects will receive darunavir plus danoprevir together with ritonavir for 10 days. Anticipated time on study treatment is 20 days.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A danoprevir

Group Type ACTIVE_COMPARATOR

danoprevir

Intervention Type DRUG

100 mg q12h

ritonavir

Intervention Type DRUG

100 mg q12h

B darunavir

Group Type PLACEBO_COMPARATOR

darunavir

Intervention Type DRUG

600 mg q12h

ritonavir

Intervention Type DRUG

100 mg q12h

C danoprevir/darunavir

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

100 mg q12h

darunavir

Intervention Type DRUG

600 mg q12h

ritonavir

Intervention Type DRUG

100 mg q12h

Interventions

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danoprevir

100 mg q12h

Intervention Type DRUG

darunavir

600 mg q12h

Intervention Type DRUG

ritonavir

100 mg q12h

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy non-smoking male and female adults, 18 - 55 years of age, inclusive
* Healthy status defined by absence of evidence of any active or chronic disease
* Medical history without major, recent, or ongoing pathology
* Weight \>/= 55 kg
* Body mass index (BMI) 18.0 - 32.0 kg/m2
* Ability and willingness to abstain from alcohol, xanthine-containing beverages or food (coffee, tea, cola, chocolate, "energy drinks") from 72 hours prior to entry in the clinical site center until discharge
* Females of child-bearing potential and males and their female partners of child-bearing potential must agree to use 2 forms of contraception, one of which must be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom and diaphragm; acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device (IUD) and/or spermicide

Exclusion Criteria

* Pregnant or lactating females or males with female partners who are pregnant or lactating
* Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections
* Positive test 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 within 30 days before the first dose of study medication
* History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
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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NP28089

Identifier Type: -

Identifier Source: org_study_id