A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
Completed · Phase 1
Conditions studied: Renal Insufficiency, Chronic
In brief
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.
Key facts
- Study ID
- NCT00596518
- Run by
- Pfizer
- People needed
- 30
- Starts
- 2007-10-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2017-03-10
Who can join
Age: 18 and older, up to 77. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg
- Subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications
You may not qualify if…
- Women who are pregnant, nursing or women of childbearing potential
- Subjects with acute renal disease.
Where it is running
- Pfizer Investigational Site — Miami, Florida, United States
- Pfizer Investigational Site — Orlando, Florida, United States
- Pfizer Investigational Site — Minneapolis, Minnesota, United States
- Pfizer Investigational Site — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.