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

Wyeth is now a wholly owned subsidiary of Pfizer27 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Hepatic Insufficiency

Interventions

HCV-796DRUG

HCV-796 1000mg single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Unnamed facility

Gainesville, Florida, United States

Unnamed facility

Orlando, Florida, United States

Unnamed facility

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

To assess PK in subjects with chronic hepatic impairment and in matched healthy adults

Time frame: 7 days

Secondary Outcomes

To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults

Time frame: 15 days

Data from ClinicalTrials.gov

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