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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Hepatitis C; Hepatic Insufficiency

Treatments: Drug: HCV-796

Study type: Interventional

Funder types: Industry

Identifiers

NCT00314054

3173A1-105

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 1 patient group

1

Experimental group

Description:

HCV-796 1000mg single dose

Treatment:

Drug: HCV-796