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

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NCT00314054

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Gainesville, Florida, 32608 United States
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatitis C, Hepatic Insufficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00314054
Pfizer
Completed
Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults

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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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hepatitis C
  • Hepatic Insufficiency
Drug: HCV-796
HCV-796 1000mg single dose
Experimental: 1
HCV-796 1000mg single dose
Intervention: Drug: HCV-796
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
October 2007
October 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00314054
3173A1-105
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
ViroPharma
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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