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PF-05297909

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last 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

Clinical trial landscape

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 used for?

PF-05297909 is an investigational small molecule being studied in healthy adults. It is being evaluated for safety and to measure its concentrations in blood and cerebrospinal fluid after a single dose. It is not approved for any condition and remains in clinical development.

Who makes PF-05297909?

PF-05297909 is being developed by Pfizer, Inc., which trades under the ticker PFE. The company is conducting clinical research on this investigational small molecule in healthy volunteers.

What phase is PF-05297909 in?

PF-05297909 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The single Phase 1 trial has been completed.

What clinical trials is PF-05297909 in?

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

Is PF-05297909 FDA approved?

PF-05297909 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy volunteers. It remains in clinical development and has not been authorized for any medical use.