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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Page 1 of 1 (3 locations)

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