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LY2801653

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Jun 19, 2015

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 Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02370485A Study of LY2801653 in Healthy Participants Who Are Not Able to Have ChildrenPHASE1 COMPLETED 23 — — Feb 1, 2015May 1, 2015Jun 19, 20151 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics: Maximum Concentration (Cmax) for LY2801653
Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3
Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653
Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3
Secondary Endpoints
Pharmacokinetics: Maximum Concentration (Cmax) of LY2801653 and Major Metabolites LSN2800870 and LSN2887652
Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3
Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653 and Major Metabolites LSN2800870 and LSN2887652
Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
LY2801653 Reference - FastedEXPERIMENTALSingle oral dose of LY2801653 (Reference Formulation) administered in fasted state in one of three study periods.
LY2801653 Test - FastedEXPERIMENTALSingle oral dose of LY2801653 (Test Formulation) administered in fasted state in one of three study periods.
LY2801653 Test - FedEXPERIMENTALSingle oral dose of LY2801653 (Test Formulation) administered with a high fat meal in one of three study periods.
Interventions
NameTypeDescription
LY2801653DRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Generally healthy sterile male and female participants * Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive * Are willing and able to eat the protocol specified high-fat breakfast Exclusion Criteria: * Have consumed grapefruits or grapefrui...

Countries:United States
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