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PF-05297909

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 13, 2012

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
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment51
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01462851A Study To Observe Safety And Concentrations Of PF-05297909 And Proteins In Both Blood And Cerebrospinal Fluid After A Single Dose Of PF-05297909 In Healthy AdultsPHASE1 COMPLETED 51 — — Sep 1, 2011Feb 1, 2012Mar 13, 20122 United States
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Study Endpoints
Primary Endpoints
Plasma area under the curve last (AUClast) pharmacokinetic parameter
Day 1 to Day 3
Plasma apparent clearance (CL/F) pharmacokinetic parameter
Day 0 to Day 3
Clinical potency of PF 05297909 for reduction in CSF levels of Abeta40, Abeta42, and/or AbetaX via estimation of the IC50 from a population PK/PD (PPK/PD) model
Day 0 to Day 3
Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter
Day 1 to Day 3
Plasma half-life (t1/2) pharmacokinetic parameter
Day 1 to Day 3
Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter
Day 1 to Day 3
CSF concentration summary by time point for PF 05297909.
Day 1 to Day 3
Change from baseline in CSF levels of Abeta40
Day 1 to Day 3
Change from baseline in CSF levels of Abeta42
Day 1 to Day 3
Change from baseline in CSF levels of AbetaX
Day 1 to Day 3
Change from baseline in CSF levels of sAPPalpha
Day 1 to Day 3
Change from baseline in CSF levels of sAPPbeta.
Day 1 to Day 3
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Dose EscalationEXPERIMENTALAscending doses in healthy volunteers
Part 2: CSF PKPDEXPERIMENTALPharmacokinetic and pharmacodynamic cerebrospinal fluid assessment
Interventions
NameTypeDescription
PF-05297909 25 mgDRUGSingle oral (PO) dose, PF-05297909 25 mg
PF-05297909 100 mgDRUGSingle oral (PO) dose, PF-05297909 100 mg
PF-05297909 250 mgDRUGSingle oral (PO) dose, PF-05297909 250 mg
PF-05297909 525 mgDRUGSingle oral (PO) dose, PF-05297909 525 mg
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, inc...

Countries:United States
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