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Scopolamine

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Nov 14, 2018

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01213355Scopolamine Challenge StudyPHASE1 COMPLETED 38 — — Apr 1, 2011Aug 1, 2011Nov 14, 20181 France
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Study Endpoints
Primary Endpoints
Groton Maze Learning Task (Total Errors); included in CogState Battery of Tests.
Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
Secondary Endpoints
Detection Task (Speed; included in CogState Test Battery)
Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
One Card Learning Task (Accuracy of performance; included in CogState Test Battery)
Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
Continuous Paired Associate Learning Task (Number of errors; included in CogState Test Battery)
Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
PlaceboEXPERIMENTALplacebo, plus scopolamine 0.5 mg
PF-05212377 5 mg, plus scopolamine 0.5 mg;EXPERIMENTAL -
PF-05212377 20 mg, plus scopolamine 0.5 mg;EXPERIMENTAL -
PF-05212377 60 mg, plus scopolamine 0.5 mg;EXPERIMENTAL -
donepezil 10 mg, plus scopolamine 0.5 mg.ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
PlaceboDRUGCapsule, single dose, oral, 1 day
ScopolamineDRUGinjectable subcutaneous formulation, single dose, 1 day
PF-05212377DRUG5 mg, PF-05212377, capsule, single dose, 1 day
DonepezilDRUGTablet, 10mg, single dose, 1 day
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects of non child bearing potential (WONCBP) between the ages of 18 and 55 years, inclusive. * Body Mass index (BMI) of between 17.5 to 30.5 kg/m2 inclusive; and a total body weight greater than or equal to 50 kg (110 lbs). Exclusion Criteria: ...

Countries:France
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