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-LY3871801

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Jan 10, 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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials4
Total Enrollment94
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06049108A Study of Carbon-14-Labelled [14C] LY3871801 in Healthy Male ParticipantsPHASE1 COMPLETED 8 — — Sep 15, 2023Nov 3, 2023Jan 8, 20241 United States
NCT05960851A Study of LY3871801 in Healthy Asian and Non-Asian ParticipantsPHASE1 COMPLETED 32 — — Aug 9, 2023Oct 25, 2023Jan 10, 20241 United States
NCT05602675A Drug Interaction Study of LY3871801 in Healthy ParticipantsPHASE1 COMPLETED 39 — — Nov 2, 2022Mar 29, 2023Apr 18, 20231 United States
NCT05222399A Study of LY3871801 in Healthy ParticipantsPHASE1 COMPLETED 15 — — Feb 4, 2022Mar 11, 2022Mar 18, 20221 Singapore
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Study Endpoints
Primary Endpoints
Urinary Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Predose up to Day 7 post dose
Fecal Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Predose up to Day 7 post dose
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Predose up to 24 days post dose

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Part 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Methotrexate
Predose up to 48 hours postdose

Part 1: PK: Cmax of Methotrexate

Part 1: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Methotrexate
Predose up to 48 hours postdose

Part 1: PK: AUC\[0-∞\] of Methotrexate

Part 2: PK: Cmax of Midazolam
Predose up to 24 hours postdose
Part 2: PK: AUC[0-∞] of Midazolam
Predose up to 24 hours postdose

Part 2: PK: AUC\[0-∞\] of Midazolam

Part 2: PK: Cmax of S-warfarin
Predose up to 96 hours postdose
Part 2: PK: AUC[0-∞] of S-warfarin
Predose up to 96 hours postdose

Part 2: PK: AUC\[0-∞\] of S-warfarin

Part 2: PK: Cmax of Dextromethorphan
Predose up to 72 hours postdose
Part 2: PK: AUC[0-∞] of Dextromethorphan
Predose up to 72 hours postdose

Part 2: PK: AUC\[0-∞\] of Dextromethorphan

Part 2: PK: Cmax of Repaglinide
Predose up to 24 hours postdose
Part 2: PK: AUC[0-∞] of Repaglinide
Predose up to 24 hours postdose

Part 2: PK: AUC\[0-∞\] of Repaglinide

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3871801
Predose through Day 4

PK: Cmax of LY3871801

PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3871801
Predose through Day 4

PK: AUC\[0-∞\] of LY3871801

Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time From zero to Infinity (AUC [0-∞]) of [¹⁴C]-LY3871801
Predose up to Day 7 post dose
PK: AUC [0-∞] of Total Radioactivity in Plasma and Whole Blood
Predose up to Day 7 post dose
PK: Maximum Concentration (Cmax) of [¹⁴C]-LY3871801
Predose up to Day 7 post dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
[14C]-LY3871801EXPERIMENTALSingle dose of \[¹⁴C\]-LY3871801 administered orally
LY3871801 (Part A)EXPERIMENTALLY3871801 administered orally in Japanese and Non-Asian Participants.
Placebo (Part A)PLACEBO_COMPARATORPlacebo administered orally in Japanese and Non-Asian Participants.
LY3871801 (Part B)EXPERIMENTALLY3871801 administered orally in Chinese Participants.
Placebo (Part B)PLACEBO_COMPARATORPlacebo administered orally in Chinese Participants.
LY3871801 + Methotrexate (Part 1)EXPERIMENTALLY3871801 administered orally in combination with methotrexate given orally.
LY3871801 + Repaglinide + Drug Cocktail (Part 2)EXPERIMENTALLY3871801 administered orally in combination with repaglinide given orally and drug cocktail which includes warfarin, dextromethorphan and midazolam administered orally.
LY3871801 (Period 1)EXPERIMENTALLY3871801 solid dispersion suspension administered orally.
LY3871801 (Period 2)EXPERIMENTALLY3871801 crystalline freebase tablet administered orally.
Interventions
NameTypeDescription
[14C]-LY3871801DRUGAdministered orally
LY3871801DRUGAdministered orally.
PlaceboDRUGAdministered orally.
MethotrexateDRUGAdministered orally.
WarfarinDRUGAdministered orally.
DextromethorphanDRUGAdministered orally.
MidazolamDRUGAdministered orally.
RepaglinideDRUGAdministered orally.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male participants who are overtly healthy as determined by medical evaluation * Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²), inclusive * Males who agree to use highly effective or effective methods of contraception Exclusion Criteria: * Have kn...

Countries:United StatesSingapore
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