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

Renal Insufficiency, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596518
• Other study ID #: A7941014
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2008
• Last updated: March 7, 2017
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: March 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 77 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• PF-00734200
The drug is administered as a single dose of four 5-mg tablets

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve from time 0 until last observation (AUCtlast)		3-6 days
Primary	Maximum serum concentration (Cmax)		3-6 days
Secondary	AUC extrapolated to infinity (AUCinf)		3-6 days
Secondary	Time of Cmax (Tmax)		3-6 days
Secondary	Half life (T1/2)		3-6 days
Secondary	Renal clearance (CLr)		3-6 days
Secondary	Hemodialysis clearance (CLd)		3 days