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LY3023414 Reference Fasted

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Nov 4, 2016

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02818335A Study of LY3023414 Formulations and the Effect of FoodPHASE1 COMPLETED 30 — — Jul 1, 2016Oct 1, 2016Nov 4, 20161 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Area under the concentration versus time curve (AUC) from time zero to infinity (AUC[0-inf]) of LY3023414
Pre-dose through 2 days post-dose in each period
Pharmacokinetics (PK): Area under the concentration from time zero to time t, where t is the last time point with a measurable concentration (AUC [0-tlast]) of LY3023414
Pre-dose through 2 days post-dose in each period
Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3023414
Pre-dose through 2 days post-dose in each period
Pharmacokinetics (PK): Observed time of maximum concentration (tmax)
Pre-dose through 2 days post-dose in each period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3023414 Reference FastedEXPERIMENTALSingle oral dose of LY3023414 (Reference) on day one fasting.
LY3023414 Test FastedEXPERIMENTALSingle oral dose of LY3023414 (Test) on day one fasting.
LY3023414 Test FedEXPERIMENTALSingle oral dose of LY3023414 (Test) on day one after a meal.
Interventions
NameTypeDescription
LY3023414 Reference FastedDRUGAdministered Orally
LY3023414 Test FastedDRUGAdministered Orally
LY3023414 Test FedDRUGAdministered Orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy surgically sterile or postmenopausal females and sterile males * Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive at screening Exclusion Criteria: * Cannot be investigative site personnel directly affiliated with this ...

Countries:United States
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