Back to resultsA Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
Primary Purpose
Renal Insufficiency, Chronic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-00734200
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency, Chronic
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PF-00734200
Arm Description
Outcomes
Primary Outcome Measures
Area under the curve from time 0 until last observation (AUCtlast)
Maximum serum concentration (Cmax)
Secondary Outcome Measures
AUC extrapolated to infinity (AUCinf)
Time of Cmax (Tmax)
Half life (T1/2)
Renal clearance (CLr)
Hemodialysis clearance (CLd)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00596518
Brief Title
A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
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 Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-00734200
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-00734200
Intervention Description
The drug is administered as a single dose of four 5-mg tablets
Primary Outcome Measure Information:
Title
Area under the curve from time 0 until last observation (AUCtlast)
Time Frame
3-6 days
Title
Maximum serum concentration (Cmax)
Time Frame
3-6 days
Secondary Outcome Measure Information:
Title
AUC extrapolated to infinity (AUCinf)
Time Frame
3-6 days
Title
Time of Cmax (Tmax)
Time Frame
3-6 days
Title
Half life (T1/2)
Time Frame
3-6 days
Title
Renal clearance (CLr)
Time Frame
3-6 days
Title
Hemodialysis clearance (CLd)
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Pfizer Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
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