Overview

Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
All
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 impact of varying degrees of hepatic impairment on the pharmacokinetics, safety and toleration of 200 mg PF-00868554 administered as a single-dose.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Pfizer
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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;