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Begacestat

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Apr 4, 2011

Begacestat development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2009

Begacestat target and mechanism

Molecular targetAPH1A, PSENEN, APH1B, PSEN1, NCSTN, PSEN2
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Begacestat clinical trials

Begacestat · 1 trial · 1 indication

Phase 1 1
NCT00959881Study Evaluating The Coadministration of Begacestat And DonepezilHealthy Subjects
COMPLETED47 Analytics
PHASE1COMPLETED
Study Evaluating The Coadministration of Begacestat And Donepezil
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG).
5 months

Secondary Endpoints

Pharmacokinetic parameters including Cmax, AUC, and t 1/2
5 months
Safety and tolerability as assessed by results of 12-lead ECGs, cardiac telemetry, laboratory tests, vital signs, physical examinations and reported adverse events.
5 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Donepezil plus placeboEXPERIMENTAL -
Donepezil plus begacestatEXPERIMENTAL -

Interventions

NameTypeDescription
Donepezil plus placeboDRUG5- and 10-mg tablets, single dose
DonepezilDRUG5- and 10-mg tablets, single dose
BegacestatDRUG6 x 50-mg capsules, single dose
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy * Men and women of non-childbearing potential * Non smoker or smoker of \<10 cigarettes per day and able to refrain from smoking during study * 18-50 years old Exclusion Criteria: * Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocr...

Countries:United States
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Frequently asked questions about Begacestat

What is Begacestat?

Begacestat is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It is a gamma-secretase inhibitor that has been studied in Phase 1 clinical development. The specific disease indications for begacestat have not been disclosed, and it is not approved for any use.

What does Begacestat target?

Begacestat targets the gamma-secretase complex, specifically the subunits APH1A, APH1B, PSEN1, PSEN2, PSENEN, and NCSTN. It acts as an inhibitor of this complex. Gamma-secretase is involved in cleaving amyloid precursor protein, and inhibiting it reduces amyloid-beta production.

Who makes Begacestat?

Begacestat is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the sponsor of the clinical trial evaluating the drug.

What phase is Begacestat in?

Begacestat is in Phase 1 clinical development. It has not been approved by the FDA or any regulatory agency. One Phase 1 trial has been completed, and there are currently no active trials of begacestat.

What clinical trials is Begacestat in?

Begacestat has been evaluated in one completed Phase 1 trial, NCT00959881, titled "Study Evaluating The Coadministration of Begacestat And Donepezil." The trial enrolled 47 healthy adult volunteers in the United States and was randomized, double-blind, and controlled.