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Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults

NCT ID: NCT00314054

Last Updated: 2008-04-14

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-10-31

Brief Summary

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The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with chronic hepatic impairment and in matched healthy adults.

Detailed Description

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Conditions

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Hepatitis C Hepatic Insufficiency

Keywords

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Hepatitis C Hepatic Impairment Healthy Volunteer Phase 1 Hepacivirus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

HCV-796 1000mg single dose

Group Type EXPERIMENTAL

HCV-796

Intervention Type DRUG

HCV-796 1000mg single dose

Interventions

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HCV-796

HCV-796 1000mg single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women of non-childbearing potential.
* Hepatic impairment subjects: Child-Pugh class A, B, or C according to the C-P classification based on history, physical examination, and laboratory test results.
* Healthy volunteers: healthy as determined by the investigator.

Exclusion Criteria

* History of alcoholism within 1 year.
* Hepatic impairment subjects: evidence of unstable clinically significant disease other than impaired hepatic function.
* Healthy volunteers: positive serologic findings for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ViroPharma

INDUSTRY

Sponsor Role collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Gainesville, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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3173A1-105

Identifier Type: -

Identifier Source: org_study_id