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-STX-478

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: May 25, 2025

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
NCT06901336A Study of LY4064809 [14C]-STX-478 in Healthy Male ParticipantsPHASE1 COMPLETED 8 — — Mar 20, 2025May 6, 2025May 25, 20251 United States
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Study Endpoints
Primary Endpoints
Percentage of the Total Radioactive Dose in Urinary, Fecal, and Urinary and Fecal Combined Excretion
Baseline, Up to Day 29
Secondary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) of 14C and STX-478
Predose up to Day 29 Post Dose
PK: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC 0- inf) of 14C and STX-478
Predose up to Day 29 Post Dose
Total Radioactivity Recovered in Urine and Feces
Predose up to Day 29 Post Dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
[14C]-STX-478EXPERIMENTALHealthy participants will receive a single dose of \[14C\]-STX-478.
Interventions
NameTypeDescription
[14C]-STX-478DRUGoral administration
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at Screening; body weight ≥ 55.0 kg and ≤ 100.0 kg at Screening. * Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) and human immunodeficiency virus antibody and antige...

Countries:United States
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