NCT00596518

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

A Phase 1, Open-Label Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PF-00734200 Administered To Subjects With Various Degrees Of Renal Impairment And Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 77 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
DRUG	PF-00734200	The drug is administered as a single dose of four 5-mg tablets

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-01-17
• Last updated: 2017-03-10

Locations

4 sites across 1 country: United States