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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314054
• Other study ID #: 3173A1-105
• Status: Completed
• Phase: Phase 1
• First received: April 10, 2006
• Last updated: April 10, 2008
• Start date: May 2006
• Est. completion date: October 2007

Study information

• Verified date: April 2008
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Hepatitis C

Intervention

Drug:
• HCV-796
HCV-796 1000mg single dose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer	ViroPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess PK in subjects with chronic hepatic impairment and in matched healthy adults		7 days	No
Secondary	To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults		15 days	Yes