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-LY3023414

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Nov 23, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02575703A Study of [¹⁴C]-LY3023414 in Healthy ParticipantsPHASE1 COMPLETED 8 — — Oct 1, 2015Nov 1, 2015Nov 23, 20151 United States
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Study Endpoints
Primary Endpoints
Urinary Excretion of LY3023414 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Baseline up to 144 hours postdose
Fecal Excretion of LY3023414 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Baseline up to 144 hours postdose
Secondary Endpoints
Plasma Pharmacokinetics of LY3023414 and Radioactivity Maximum Observed Concentration (Cmax)
Baseline up to 144 hours postdose
Plasma Pharmacokinetics of LY3023414 and Radioactivity Time of Maximum Observed Concentration (Tmax)
Baseline up to 144 hours postdose
Plasma Pharmacokinetics of LY3023414 and Radioactivity Area Under the Concentration Versus Time Curve (AUC)
Baseline up to 144 hours postdose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
[¹⁴C]-LY3023414EXPERIMENTALSingle oral dose of \[¹⁴C\]-LY3023414 administered on Day 1
Interventions
NameTypeDescription
[¹⁴C]-LY3023414DRUGLY3023414 in solution containing approximately 100 microCi \[¹⁴C\]-LY3023414
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy men or women * Male participants: Will be sterile (including vasectomy), confirmed by documentation. Men who are sexually active with a pregnant partner agree to use a condom for 91 days from the time of dosing * Female participants: Women not of childbearing pote...

Countries:United States
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