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PD-0332334

Phase 1

Renal Dialysis | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Feb 17, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00730145A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular HemodialysisPHASE1 COMPLETED 8 — — Sep 1, 2008Jan 1, 2009Feb 17, 20101 United States
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Study Endpoints
Primary Endpoints
Maximum plasma concentration (Cmax) of PD-0332334 and time of maximum plasma concentration (Tmax). Half-life of PD-0332334 in this patient population with hemodialysis and without hemodialysis
0 to 8 days
Hemodialysis clearance of PD-0332334 from the blood, the total amount and fraction of total dose of PD-0332334 removed from the blood via hemodialysis, and the half-life of drug removal from the blood via hemodialysis
0 to 8 days
Area under the curve (AUC) of PD-0332334 from time of study medication administration to infinity (AUCinf); AUC of PD-0332334 from time of study medication administration to last quantifiable plasma concentration (AUClast).
0 to 8 days
Secondary Endpoints
Assess adverse events, findings from physical examinations, clinical safety laboratory assessments, ECG, vital signs.
0 to 8 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
PD-0332334EXPERIMENTAL -
Interventions
NameTypeDescription
PD-0332334DRUGA single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients receiving regular hemodialysis * Male or female patients 18 to 65 years Exclusion Criteria: * Severe heart failure * Renal transplant or renal allograft * Illicit drug use (with the exception of prescribed sedatives)

Countries:United States
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