Status:
COMPLETED
Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborating Sponsors:
ViroPharma
Conditions:
Hepatitis C
Hepatic Insufficiency
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00314054
Start Date
May 1 2006
End Date
October 1 2007
Last Update
April 14 2008
Active Locations (3)
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1
Gainesville, Florida, United States, 32608
2
Orlando, Florida, United States, 32809
3
Saint Paul, Minnesota, United States, 55114