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

Completed · Phase 1

Conditions studied: Hepatitis C, Hepatic Insufficiency

In brief

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.

Key facts

Study ID

NCT00314054

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

27

Starts

2006-05-01

Expected to finish

2007-10-01

Last updated by the study team

2008-04-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Gainesville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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