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PF-05297909

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Mar 13, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded

PF-05297909 clinical trials

PF-05297909 · 1 trial · 1 indication

Phase 1 1
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 AdultsHealthy
COMPLETED51 Analytics
PHASE1COMPLETED
A 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 Adults
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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 to 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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Frequently asked questions about PF-05297909

What is PF-05297909?

PF-05297909 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE). It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed.

Who is developing PF-05297909?

PF-05297909 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of the compound.

What phase is PF-05297909 in?

PF-05297909 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed.

What clinical trials is PF-05297909 in?

PF-05297909 has been evaluated in one completed Phase 1 trial, NCT01462851. The study observed safety and concentrations of PF-05297909 and proteins in blood and cerebrospinal fluid after a single dose in 51 healthy adults in the United States.