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Trial record 1 of 1 for:    NCT00596518
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A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00596518
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : March 10, 2017
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Drug: PF-00734200 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PF-00734200 Drug: PF-00734200
The drug is administered as a single dose of four 5-mg tablets

Primary Outcome Measures :
  1. Area under the curve from time 0 until last observation (AUCtlast) [ Time Frame: 3-6 days ]
  2. Maximum serum concentration (Cmax) [ Time Frame: 3-6 days ]

Secondary Outcome Measures :
  1. AUC extrapolated to infinity (AUCinf) [ Time Frame: 3-6 days ]
  2. Time of Cmax (Tmax) [ Time Frame: 3-6 days ]
  3. Half life (T1/2) [ Time Frame: 3-6 days ]
  4. Renal clearance (CLr) [ Time Frame: 3-6 days ]
  5. Hemodialysis clearance (CLd) [ Time Frame: 3 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00596518

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United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169
Pfizer Investigational Site
Orlando, Florida, United States, 32809
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
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Study Director: Pfizer Call Center Pfizer
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Responsible Party: Pfizer Identifier: NCT00596518    
Other Study ID Numbers: A7941014
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases