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vabicaserin

Phase 1

Healthy Subjects | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 11, 2009

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00928551Comparative Formulation Study of VabicaserinPHASE1 COMPLETED 15Jun 1, 2009Sep 1, 2009Sep 11, 20091 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetic parameters including plasma concentrations, Cmax, and AUC.
2 months
Secondary Endpoints
Safety assessment as measured by evaluating any reported adverse events, scheduled physical examinations, vital sign measurements, ECGs, and clinical laboratory results.
2 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
vabicaserinDRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after investigational product administration. * Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to ab...

Countries:United States
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