A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
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
1 other identifier
interventional
30
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2007
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 8, 2008
CompletedFirst Posted
Study publicly available on registry
January 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedMarch 10, 2017
March 1, 2017
9 months
January 8, 2008
March 7, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the curve from time 0 until last observation (AUCtlast)
3-6 days
Maximum serum concentration (Cmax)
3-6 days
Secondary Outcomes (5)
AUC extrapolated to infinity (AUCinf)
3-6 days
Time of Cmax (Tmax)
3-6 days
Half life (T1/2)
3-6 days
Renal clearance (CLr)
3-6 days
Hemodialysis clearance (CLd)
3 days
Study Arms (1)
PF-00734200
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Women who are pregnant, nursing or women of childbearing potential
- Subjects with acute renal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (4)
Pfizer Investigational Site
Miami, Florida, 33169, United States
Pfizer Investigational Site
Orlando, Florida, 32809, United States
Pfizer Investigational Site
Minneapolis, Minnesota, 55404, United States
Pfizer Investigational Site
Knoxville, Tennessee, 37920, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2008
First Posted
January 17, 2008
Study Start
October 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
March 10, 2017
Record last verified: 2017-03