Status:
COMPLETED
Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554
Lead Sponsor:
Pfizer
Conditions:
HEPATITIS C (HCV)
Eligibility:
All Genders
18-62 years
Phase:
PHASE1
Brief Summary
The metabolism of PF-00868554 is primarily mediated by CYP3A, and it is anticipated that hepatic impairment will modify PF-00868554 plasma concentrations. Hence, it is important to determine the impac...
Eligibility Criteria
Inclusion
- Male or females subjects of non-childbearing potential between the ages of 18 and 62 years of age, inclusive;
- Body Mass Index (BMI) of approximately 18 to 35 kg/m2; and a total body weigh \>50 kg (110 lbs);
Exclusion
- Subjects with Class C classification (Severe - Child-Pugh Scores greater than 10);
- Severe ascites and/or pleural effusion;
- Had a transplanted kidney, heart or liver;
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00651027
Start Date
February 1 2008
End Date
September 1 2008
Last Update
January 3 2014
Active Locations (3)
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1
Pfizer Investigational Site
Anaheim, California, United States, 92801
2
Pfizer Investigational Site
Anaheim, California, United States, 92804
3
Pfizer Investigational Site
Miami, Florida, United States, 33169