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

Phase 1

Completed

• Conditions: Hepatitis C; Hepatic Insufficiency
• Interventions: Drug: HCV-796

• Registration Number: NCT00314054
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-04-10
• Study First Submitted QC: 2006-04-11
• Study First Posted: 2006-04-12
• Study Start: 2006-05
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-10
• Last Update Posted: 2008-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	HCV-796	HCV-796 1000mg single dose

Primary Outcome Measures

Name	Time	Method
To assess PK in subjects with chronic hepatic impairment and in matched healthy adults	7 days

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults	15 days