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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00596518

Purpose

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.

Condition	Intervention	Phase
Kidney Failure, Chronic Renal Insufficiency, Chronic	Drug: PF-00734200	Phase I

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title:	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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Area under the curve from time 0 until last observation (AUCtlast) [ Time Frame: 3-6 days ] [ Designated as safety issue: No ]
Maximum serum concentration (Cmax) [ Time Frame: 3-6 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AUC extrapolated to infinity (AUCinf) [ Time Frame: 3-6 days ] [ Designated as safety issue: No ]
Time of Cmax (Tmax) [ Time Frame: 3-6 days ] [ Designated as safety issue: No ]
Half life (T1/2) [ Time Frame: 3-6 days ] [ Designated as safety issue: No ]
Renal clearance (CLr) [ Time Frame: 3-6 days ] [ Designated as safety issue: No ]
Hemodialysis clearance (CLd) [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	October 2007
Study Completion Date:	July 2008

Arms	Assigned Interventions
PF-00734200: Experimental	Drug: PF-00734200 The drug is administered as a single dose of four 5-mg tablets

Eligibility

Ages Eligible for Study:	18 Years to 77 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Women who are pregnant, nursing or women of childbearing potential
Subjects with acute renal disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596518

Locations

United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32809
Pfizer Investigational Site
Miami, Florida, United States, 33169
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55404
United States, Tennessee
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37920

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A7941014
Study First Received:	January 8, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00596518
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009