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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00314054

Enrollment

Registered

2006-04-12

Start date

2006-05-31

Completion date

2007-10-31

Last updated

2008-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Insufficiency, Hepatitis C

Keywords

Hepatitis C, Hepatic Impairment, Healthy Volunteer, Phase 1, Hepacivirus

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.

Interventions

DRUGHCV-796

HCV-796 1000mg single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To assess PK in subjects with chronic hepatic impairment and in matched healthy adults	7 days

Secondary

Measure	Time frame
To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults	15 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026