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LY2775240

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Nov 7, 2017

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 Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02963779A Study of LY2775240 in Healthy ParticipantsPHASE1 COMPLETED 35Dec 1, 2016Oct 5, 2017Nov 7, 20171 Singapore
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Study Endpoints
Primary Endpoints
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through to final follow-up at approximately Week 14
Secondary Endpoints
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2775240
Baseline through Day 5
Pharmacokinetics: Time to Maximal Blood Concentration of LY2775240
Baseline through Day 5
Pharmacokinetics: Maximum Concentration of LY2775240 in Blood
Baseline through Day 5
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY2775240 (Part A)EXPERIMENTALEscalating oral doses of LY2775240 administered in healthy participants
LY2775240 (Part B)EXPERIMENTALOral dose of LY2775240 in healthy participants
Placebo (Part A)PLACEBO_COMPARATORPlacebo administered orally in healthy participants
Apremilast (Part B)ACTIVE_COMPARATOROral dose of apremilast in healthy participants
Interventions
NameTypeDescription
LY2775240DRUGAdministered orally
PlaceboDRUGAdministered orally
ApremilastDRUGAdministered orally
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Eligibility Criteria
Age Range21 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy adult male or a female who cannot get pregnant * Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter square (kg/m²), inclusive * Have normal blood pressure, pulse rate, electrocardiogram (ECG) and medical t...

Countries:Singapore
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