Overview

A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Pfizer
Criteria
Inclusion Criteria:

1. Subjects must meet one of the following renal function categories Normal renal
function Mild renal impairment Moderate renal impairment End stage renal disease
requiring chronic hemodialysis

2. Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight
greater than 50 kg

3. Subjects in the normal renal function category must be healthy and not receiving any
chronic treatment with prescription or non-prescription medications

Exclusion Criteria:

1. Women who are pregnant, nursing or women of childbearing potential

2. Subjects with acute renal disease.