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PSI-697

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 4, 2019

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03860506Study Evaluating the Effects of PSI-697 on Platelets in Subjects Who SmokePHASE1 COMPLETED 30Apr 1, 2008Jul 1, 2008Mar 4, 2019 -
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Study Endpoints
Primary Endpoints
reduction of platelet monocyte aggregates
2 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PSI-697EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PSI-697DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: Inclusion Criteria: * Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12?lead electrocardiogram (ECG). * Smoker of at least 1 pack or more of cigarettes per day (20 plus or minus...

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