Skip to main content
OpenTrials
Completed

NCT Number: NCT00314054

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatic Insufficiency Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Gainesville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HCV-796

Drug

HCV-796 1000mg single dose

Primary outcomes

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

    Time frame: 7 days

Secondary outcomes

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

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Collaborators

  • ViroPharma

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 12, 2006
Registry last updated
Apr 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.