Trial | NCT00314054  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    nesbuvir ...

  • Study Participants

    27
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.
Study Started
May 31
2006
Primary Completion
Oct 31
2007
Study Completion
Oct 31
2007
Last Update
Apr 14
2008
Estimate

Drug HCV-796

HCV-796 1000mg single dose

1 Experimental

HCV-796 1000mg single dose

Criteria 

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.
No Results Posted