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

Phase 1

Completed

• Conditions: Renal Insufficiency, Chronic
• Interventions: Drug: PF-00734200

• Registration Number: NCT00596518
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-17
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PF-00734200	PF-00734200	-

Primary Outcome Measures

Name	Time	Method
Area under the curve from time 0 until last observation (AUCtlast)	3-6 days
Maximum serum concentration (Cmax)	3-6 days

Secondary Outcome Measures

Name	Time	Method
Half life (T1/2)	3-6 days
Renal clearance (CLr)	3-6 days
Time of Cmax (Tmax)	3-6 days
AUC extrapolated to infinity (AUCinf)	3-6 days
Hemodialysis clearance (CLd)	3 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Knoxville, Tennessee, United States