Text Size

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

This study has been completed.
Sponsor:
Collaborator:
ViroPharma
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00314054
First received: April 10, 2006
Last updated: April 10, 2008
Last verified: April 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Hepatic Insufficiency
 Drug: HCV-796
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To assess PK in subjects with chronic hepatic impairment and in matched healthy adults [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 27
Study Start Date: May 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
HCV-796 1000mg single dose
 Drug: HCV-796
HCV-796 1000mg single dose

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314054

Locations
United States, Florida
Gainesville, Florida, United States, 32608
Orlando, Florida, United States, 32809
United States, Minnesota
St. Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
ViroPharma
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00314054     History of Changes
Other Study ID Numbers: 3173A1-105
Study First Received: April 10, 2006
Last Updated: April 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Hepatitis C
Hepatic Impairment
Healthy Volunteer
Phase 1
Hepacivirus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 23, 2013