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A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment

NCT ID: NCT01185873

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

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-12-31

Brief Summary

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This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe hepatic impairment. Participants will be administered repeated daily doses of danoprevir and ritonavir. The anticipated time on study treatment is 10 days.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NA

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

Repeated oral doses

ritonavir

Intervention Type DRUG

Repeated oral doses

Interventions

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danoprevir

Repeated oral doses

Intervention Type DRUG

ritonavir

Repeated oral doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Healthy Volunteers:

* Adult healthy volunteers, 18-70 years of age
* Weight \>/=50.0 kg
* Body Mass Index (BMI) 18.0-40.0 kg/m2
* Ability and willingness to abstain from alcohol-containing beverages or food from 48 hours prior to entry in the clinical study center until discharge
* Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge
* Medical history without major recent or ongoing pathology

Patients with hepatic impairment:

* Adult patients, 18-70 years of age
* Weight \>/=50.0 kg
* Body Mass Index (BMI) 18.0-40.0 kg/m2
* Ability and willingness to abstain from alcohol-containing beverages or food from 48 hours prior to entry in the clinical study center until discharge
* Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge
* Stable, mild, moderate, or severe liver disease of cryptogenic, post-hepatic, hepatitis B or alcoholic origin

Exclusion Criteria

Healthy Volunteers:

* Pregnant or lactating women and male partners of women who are pregnant or lactating
* Uncontrolled treated/untreated hypertension (systolic blood pressure \>/=160 mmHg and /or diastolic blood pressure \>/=105 mmHg
* Any history of clinically significant cardiovascular or cerebrovascular disease
* Creatinine clearance \</=60 mL/min
* Positive test results for drugs or alcohol
* Donation or loss of blood over 450 ml within 60 days prior to screening

Patients with hepatic impairment:

* Pregnant or lactating women and male partners of women who are pregnant or lactating
* Uncontrolled treated/untreated hypertension (systolic blood pressure \>/=160 mmHg and /or diastolic blood pressure \>/=105 mmHg
* Any history of clinically significant cardiovascular or cerebrovascular disease
* Severe ascites at screening or admission to the clinic
* History of or current severe hepatic encephalopathy (grade 3 or higher)
* Any evidence of progressive liver disease within the last 4 weeks
* History of liver transplantation
* Creatinine clearance \</=60 mL/min
* Positive test results for drugs or alcohol
* Donation or loss of blood over 450 ml within 60 days prior to screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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

Prague, , Czechia

Site Status

Prague, , Czechia

Site Status

Bratislava, , Slovakia

Site Status

Bratislava, , Slovakia

Site Status

Countries

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United States Czechia Slovakia

Other Identifiers

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2010-020314-29

Identifier Type: -

Identifier Source: secondary_id

NP25290

Identifier Type: -

Identifier Source: org_study_id