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A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers

NCT ID: NCT01392755

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-09-30

Brief Summary

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This randomized, open-label study will evaluate the effect of food, and the effect of omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

oral doses of danoprevir

ritonavir

Intervention Type DRUG

oral doses of ritonavir

2

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

oral doses of danoprevir

omeprazole

Intervention Type DRUG

oral doses of omeprazole

ranitidine

Intervention Type DRUG

oral dose of ranitidine

ritonavir

Intervention Type DRUG

oral doses of ritonavir

Interventions

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danoprevir

oral doses of danoprevir

Intervention Type DRUG

omeprazole

oral doses of omeprazole

Intervention Type DRUG

ranitidine

oral dose of ranitidine

Intervention Type DRUG

ritonavir

oral doses of ritonavir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult healthy volunteers, aged 18 to 45 years, inclusive
* Weight \>/= 50.0 kg
* Body Mass Index (BMI) 18.0 to 32.0 kg/m2, inclusive

Exclusion Criteria

* Presence of any active or chronic disease
* Abnormal blood pressure
* Abnormal resting heart rate
* Abnormal ECG values
* History of any clinically significant cardiovascular or cerebrovascular disease
* Current smokers or subjects that have discontinued smoking \< 6 months prior to first dose of study drug
* Positive for hepatitis B, hepatitis C or HIV
* Positive test for drugs of abuse or alcohol
* Positive result for H. pylori
* Regular use of antacids, H-2 blockers, proton pump inhibitors, or any investigational drug within 30 days of first dose of study medication
* History of clinically significant gastrointestinal disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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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NP25291

Identifier Type: -

Identifier Source: org_study_id