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LY900014-U200

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: May 1, 2020

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 Trials2
Total Enrollment118
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03616977Study to Compare 2 Formulations of LY900014 in Healthy ParticipantsPHASE1 COMPLETED 69 — — Aug 3, 2018Oct 19, 2018Apr 30, 20201 Singapore
NCT03334448A Study to Compare 2 Formulations of LY900014 in Healthy ParticipantsPHASE1 COMPLETED 49 — — Dec 4, 2017Mar 15, 2018May 1, 20201 Singapore
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Study Endpoints
Primary Endpoints
Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours(h) (AUC [0-10h]) Following Administration of Each Study Arm
Period 1 through 4 Day 1: Predose, 5 minutes(m),10m,15m, 20m, 25m, 30m, 35m, 40m, 45m, 50m, 55m, 60m, 70m, 90m, 120m,150m,180m, 240m, 300m, 360m, 420m, 480m, 540m, and 600m postdose

Pharmacokinetics (PK): Insulin Lispro AUC time zero to 10 hours.

Pharmacokinetics (PK): Insulin Lispro Area Under Plasma Concentration Curve Zero to 10 Hours (AUC[0-10])
Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn, 45 mn, 50mn, 55 mn, 60mn, 70mn,90mn,120mn,150mn,180mn, 240mn,300mn,360mn,320mn, 480mn, 540mn, and 600mn (10 hours)

Insulin Lispro AUC From Time Zero to 10 hours post dose (AUC\[0-10h\])

Secondary Endpoints
Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Study Arm
Period 1 through 4 Day 1: Predose, every 10 minutes(m) for 30m prior to dosing; During clamp: every 2.5m for 30m; every 5m for 30 to 120m; every 10m for 120 to 480m, and every 20m for 480m to 600m postdose
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm
Predose, every minute from run-in and for the duration of the EC until up to 10 hours postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY900014 U-200EXPERIMENTALSingle subcutaneous (SC) dose of LY900014 U-200 in two of four study periods.
LY900014 U-100EXPERIMENTALSingle SC dose of LY900014 U-100 in two of four study periods.
LY900014-U200EXPERIMENTALSingle subcutaneous (SC) dose of 15 units (U) LY900014 U-200 in two of four study periods
LY900014-U100EXPERIMENTALSingle SC dose of 15 U LY900014 U-100 in two of four study periods
Interventions
NameTypeDescription
LY900014 U-200DRUGAdministered SC
LY900014 U-100DRUGAdministered SC
LY900014-U200DRUGAdministered SC
LY900014-U100DRUGAdministered SC
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Eligibility Criteria
Age Range21 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: \- Healthy male or a female (not pregnant and agreeable to take birth control measures until study completion) * Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²) * Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laborat...

Countries:Singapore
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