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

Completed · Phase 1

Conditions studied: HEPATITIS C (HCV)

In brief

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.

Key facts

Study ID

NCT00651027

Run by

Pfizer

People needed

24

Starts

2008-02-01

Expected to finish

2008-09-01

Last updated by the study team

2014-01-03

Who can join

Age: 18 and older, up to 62. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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);

You may not qualify if…

• 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;

Where it is running

• Pfizer Investigational Site — Anaheim, California, United States
• Pfizer Investigational Site — Anaheim, California, United States
• Pfizer Investigational Site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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