Study Stopped
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A Single Dose Study Investigating the Elimination as Well as the Tolerability of PD 0332334 in Healthy Subjects as Compared to Patients With Impaired Kidney Function.
A Phase 1, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD 0332334 In Subjects With Various Degrees Of Renal Function
1 other identifier
interventional
16
1 country
2
Brief Summary
- 1.To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body.
- 2.To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2008
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2008
CompletedFirst Posted
Study publicly available on registry
July 24, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFebruary 17, 2010
February 1, 2010
6 months
July 22, 2008
February 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F)
1 day
amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96)
5 days
PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast),
5 to 17 days depending on cohort
PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2),
5 to 17 days depending on cohort
Secondary Outcomes (1)
Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs
5 to 17 days
Study Arms (4)
Group 1-Normal
EXPERIMENTALGroup 2-Mild
EXPERIMENTALGroup 3-Moderate
EXPERIMENTALGroup 4-Severe
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers OR subjects with kidney impairment
You may not qualify if:
- Receiving hemodialysis
- clinically significant or unstable medical disease other than kidney disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (2)
Pfizer Investigational Site
Cypress, California, 90630, United States
Pfizer Investigational Site
Miami, Florida, 33169, United States
Related Links
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
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 22, 2008
First Posted
July 24, 2008
Study Start
August 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
February 17, 2010
Record last verified: 2010-02