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LY2811376

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Jul 15, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00838084A Safety Study of LY2811376 Single Doses in Healthy SubjectsPHASE1 COMPLETED 61Dec 1, 2008Jun 1, 2009Jul 15, 20091 United States
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Study Endpoints
Primary Endpoints
Clinical Effects
Predose and up to Day 6 of each period
Secondary Endpoints
Plasma concentration of LY2811376 (Cmax)
Predose and up to Day 6 of each period
Plasma concentration of LY2811376 (AUC)
Predose and up to Day 6 of each period
Amyloid beta 1-40 plasma concentrations
Predose and up to Day 6 of each period
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY2811376 Part 1EXPERIMENTALLY2811376 (5 mg up to 500 mg); once a day or twice a day for 1 day in up to 3 periods.
Placebo Part 1PLACEBO_COMPARATORonce a day or twice a day for 1 day in up to 3 periods.
LY2811376 - Part 2 low doseEXPERIMENTALSingle dose of LY2811376, dose determined by part 1
LY2811376 - Part 2 high doseEXPERIMENTALSingle dose of LY2811376, dose determined by part 1
Placebo Part 2PLACEBO_COMPARATORsingle dose
Interventions
NameTypeDescription
LY2811376DRUGOral capsules
PlaceboDRUGOral capsules
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Eligibility Criteria
Age Range20 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy men and nonchild-bearing potential women * 20 years or older * Body mass index between 18-32kg/m2 Exclusion Criteria: * Taking over-the-counter or prescription medication with the exception of vitamins or minerals or stable doses of thyroid or estrogen hormone replac...

Countries:United States
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