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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00314054

Collaborator

ViroPharma (Industry)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Hepatic Insufficiency	Drug: HCV-796	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

27 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of HCV-796 in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 HCV-796 1000mg single dose	Drug: HCV-796 HCV-796 1000mg single dose

Arm

Intervention/Treatment

Experimental: 1

HCV-796 1000mg single dose

Drug: HCV-796

HCV-796 1000mg single dose

Outcome Measures

Primary Outcome Measures

To assess PK in subjects with chronic hepatic impairment and in matched healthy adults [7 days]

Secondary Outcome Measures

To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults [15 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.