Back to resultsStudy Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
Primary Purpose
Hepatitis C, Hepatic Insufficiency
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HCV-796
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Hepatic Impairment, Healthy Volunteer, Phase 1, Hepacivirus
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
HCV-796 1000mg single dose
Outcomes
Primary Outcome Measures
To assess PK in subjects with chronic hepatic impairment and in matched healthy adults
Secondary Outcome Measures
To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults
Full Information
NCT ID
NCT00314054
First Posted
April 10, 2006
Last Updated
April 10, 2008
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators
ViroPharma
1. Study Identification
Unique Protocol Identification Number
NCT00314054
Brief Title
Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators
ViroPharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Hepatic Insufficiency
Keywords
Hepatitis C, Hepatic Impairment, Healthy Volunteer, Phase 1, Hepacivirus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
HCV-796 1000mg single dose
Intervention Type
Drug
Intervention Name(s)
HCV-796
Intervention Description
HCV-796 1000mg single dose
Primary Outcome Measure Information:
Title
To assess PK in subjects with chronic hepatic impairment and in matched healthy adults
Time Frame
7 days
Secondary Outcome Measure Information:
Title
To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
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