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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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00596518
First received: January 8, 2008
Last updated: June 10, 2010
Last verified: October 2008
  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
Renal Insufficiency, Chronic
Drug: PF-00734200
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-00734200 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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00596518     History of Changes
Other Study ID Numbers: A7941014
Study First Received: January 8, 2008
Last Updated: June 10, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 23, 2014