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Begacestat

Phase 1

Healthy Subjects | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 4, 2011

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00959881Study Evaluating The Coadministration of Begacestat And DonepezilPHASE1 COMPLETED 47 — — Aug 1, 2009Nov 1, 2009Apr 4, 20111 United States
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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 — 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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