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LY3410738

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Dec 26, 2023

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment102
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06181084A Study Comparing Different Formulations of LY3410738 in Healthy Adult ParticipantsPHASE1 COMPLETED 60 — — Oct 11, 2021Apr 28, 2022Dec 26, 20231 United States
NCT06181045A Study of LY3410738 in Healthy Adult ParticipantsPHASE1 COMPLETED 42 — — Feb 24, 2021Aug 4, 2021Dec 26, 20232 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-tlast) of LY3410738 Tablets Versus Capsules
Predose up to 48 hours postdose

PK: AUC0-tlast of LY3410738 Tablets Versus Capsules

PK: Area Under the Concentration from Hour 0 Extrapolated to Infinity (AUC0-∞) of LY3410738 Tablets Versus Capsules
Predose up to 48 hours postdose

PK: AUC0-∞ of LY3410738 Tablets Versus Capsules

PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738 Tablets Versus Capsules
Predose up to 48 hours postdose

PK: Cmax of LY3410738 Tablets Versus Capsules

PK: AUC0-tlast of LY3410738 After Standard Low-Fat Meal
Predose up to 48 hours postdose
PK: AUC0-∞ of LY3410738 After Standard Low-Fat Meal
Predose up to 48 hours postdose
PK: Cmax of LY3410738 After Standard Low-Fat Meal
Predose up to 48 hours postdose
PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fasted State
Predose up to 48 hours postdose
PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fasted State
Predose up to 48 hours postdose
PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fasted State
Predose up to 48 hours postdose
PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fed State
Predose up to 48 hours postdose
PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fed State
Predose up to 48 hours postdose
PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fed State
Predose up to 48 hours postdose
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
Baseline through 53 days

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

Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of LY3410738
Pre-dose up to 24 hours post-dose
PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of LY3410738
Pre-dose up to 48 hours post-dose
PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738
Pre-dose up to 48 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Group 1: Tablet versus CapsuleEXPERIMENTALTreatment A: LY3410738 capsule on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment B: LY3410738 tablet on Day 4 as a single oral dose in the morning 10 hours prior to and 4 hours after dosing.
Group 2: Food Effect Comparison GroupEXPERIMENTALTreatment B: LY3410738 table on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment C: LY3410738 table on Day 4 as a single oral dose in the morning 30 minutes after starting a standard low-fat meal.
Group 3: Potential of Hydrogen (pH) Effect Fasted GroupEXPERIMENTALTreatment B: LY3410738 table on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment D: Esomeprazole single oral dose once daily (QD) in the morning on Days 4 through 8 in fasted state followed by a standard low-fat meal. On Day 9, Esomeprazole a single oral dose followed by LY3410738 tablet as a single oral dose in the morning, following a fast of at least 10 hours prior to and 4 hours after esomeprazole and LY3410738 coadministration.
Group 4: pH Effect Fed GroupEXPERIMENTALTreatment C: LY3410738 table on Day 1 as a single oral dose in the morning 30 minutes after starting a standard low-fat meal. Treatment E: Esomeprazole as a single oral dose QD in the morning on Days 4 through 8, in fasted state followed by a standard low-fat meal. On Day 9, Esomeprazole as a single oral dose followed by a LY3410738 tablet in the morning in fed state standard low-fat meal.
Cohort 1 (Treatment A): LY3410738EXPERIMENTALSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.
Cohort 2 (Treatment B): LY3410738PLACEBO_COMPARATORSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.
Cohort 3 (Treatment C): LY3410738EXPERIMENTALSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
Cohort 4 (Treatment D): LY3410738EXPERIMENTALSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
Cohort 5 (Treatment E): LY3410738EXPERIMENTALSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
Cohort 6 (Treatment F): LY3410738EXPERIMENTALSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
Cohort 7 (Treatment G): LY3410738EXPERIMENTALSingle oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
Interventions
NameTypeDescription
LY3410738DRUGAdministered orally.
EsomeprazoleDRUGAdministered orally.
PlaceboDRUGAdministered orally.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive. * Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign m...

Countries:United States
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