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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Renal Insufficiency, Chronic

Treatments: Drug: PF-00734200

Study type: Interventional

Funder types: Industry

Identifiers

NCT00596518

A7941014

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

PF-00734200

Experimental group

Treatment:

Drug: PF-00734200