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LY3214996

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Oct 29, 2019

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04033341A Study of LY3214996 in Healthy ParticipantsPHASE1 COMPLETED 6Aug 1, 2019Sep 9, 2019Oct 29, 20191 United States
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Study Endpoints
Primary Endpoints
Urinary Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
Baseline through Day 8 after administration of study drug

Urinary Excretion of LY3214996 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
Baseline through Day 8 after administration of study drug
Secondary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3214996
Predose through Day 8 after administration of study drug
PK: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3214996
Predose through Day 8 after administration of study drug
Total Number of Metabolites of LY3214996
Baseline through 48 hours after administration of study drug
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3214996 + [14C]-LY3214996EXPERIMENTALA single dose of LY3214996 and \[14C\]-LY3214996 administered orally.
Interventions
NameTypeDescription
LY3214996DRUGAdministered orally
[14C]-LY3214996DRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly health males * Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive Exclusion Criteria: * Females * Male participants sexually active with a pregnant partner * Are currently enrolled in a clinical study or have participated, within the ...

Countries:United States
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