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-LY3549492

Phase 1

Healthy Male | Small molecule | Other |Eli Lilly and Company|Last Updated: Mar 28, 2024

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06194500A Study of Carbon-14-Labeled [14C]-LY3549492 in Healthy ParticipantsPHASE1 COMPLETED 18 — — Jan 3, 2024Feb 15, 2024Mar 28, 20241 United Kingdom
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Study Endpoints
Primary Endpoints
Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A
Predose up to Day 24 postdose in Part A

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

Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A
Predose up to Day 24 postdose in Part A

Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total

Pharmacokinetic (PK): Area Under the Curve (AUC) for Oral Determination of Absolute Bioavailability (F) of LY3549492 in Part B
Predose up to Day 7 postdose in Part B

PK: AUC for oral determination of absolute bioavailability (F) of LY3549492

PK: AUC for Intravenous (IV) Determination of Absolute Bioavailability (F) of LY3549492 in Part B
Predose up to Day 7 postdose in Part B

PK: AUC for IV determination of absolute bioavailability (F) of LY3549492

Secondary Endpoints
PK: Area Under the Concentration (AUC) for Radioactivity in Plasma and Whole Blood in Part A
Predose up to Day 24 postdose in Part A
PK: Maximum Concentration (Cmax) for Radioactivity in Plasma and Whole Blood in Part A
Predose up to Day 24 postdose in Part A
PK: AUC of LY3549492 in Plasma in Part A
Predose up to Day 24 postdose in Part A
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Carbon-14-Labeled [14C]-LY3549492 - Part AEXPERIMENTALCarbon-14-Labeled \[14C\]-LY3549492 administered as oral solution.
LY3549492 + [14C]-LY3549492 - Part BEXPERIMENTALLY3549492 administered as oral solution followed 3 hours later by \[14C\] LY3549492 will be administered as intravenous (IV) infusion.
Interventions
NameTypeDescription
[14C]-LY3549492DRUGAdministered as oral solution.
LY3549492DRUGAdministered orally.
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Eligibility Criteria
Age Range35 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG). * Participants who have safety laboratory test results within normal reference ranges, or results with ...

Countries:United Kingdom
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