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LY2811376

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Jul 15, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

LY2811376 · 1 trial · 1 indication

Phase 1 1
NCT00838084A Safety Study of LY2811376 Single Doses in Healthy SubjectsAlzheimer's Disease
COMPLETED61 Analytics
PHASE1COMPLETED
A Safety Study of LY2811376 Single Doses in Healthy Subjects
Alzheimer's DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about LY2811376

What is LY2811376 used for?

LY2811376 is an investigational small molecule being developed for Alzheimer's Disease. It is a Phase 1 drug candidate that was studied in a completed clinical trial in healthy subjects. The drug is not approved and remains in clinical development.

Who makes LY2811376?

LY2811376 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is an investigational small molecule intended for the treatment of Alzheimer's Disease.

What phase is LY2811376 in?

LY2811376 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a safety study of single doses in healthy subjects. The drug is investigational and has not been approved for any use.

What clinical trials is LY2811376 in?

LY2811376 has been studied in one completed clinical trial, NCT00838084, titled 'A Safety Study of LY2811376 Single Doses in Healthy Subjects.' This Phase 1 trial enrolled 61 participants in the United States and was placebo-controlled, randomized, and double-blind.

Is LY2811376 FDA approved?

LY2811376 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy subjects for Alzheimer's Disease. The drug is still in clinical development and has not been approved for any indication.