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SRA-444

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Jul 9, 2008

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00499200Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor OccupancyPHASE1 COMPLETED 42Oct 1, 2007Jun 1, 2008Jul 9, 20081 Sweden
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of ascending single oral doses of SRA-444 in healthy elderly subjects and subjects with Alzheimer's disease
after each dose group completion
To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET
1 month
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SRA-444 + PlaceboEXPERIMENTALExperimental; Placebo
Interventions
NameTypeDescription
SRA-444DRUG -
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Men or women from 60 years of age at screening. * 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). Exclusion criteria: * History of drug abuse ...

Countries:Sweden
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