Recent Updates
Recently added Catalysts

Merestinib

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Aug 29, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02779738A Study of Merestinib (LY2801653) in Healthy ParticipantsPHASE1 COMPLETED 24 — — May 1, 2016Aug 1, 2016Aug 29, 20161 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Merestinib for High-Fat Meal and Fasted State
Predose through 120 hours after administration of study drug
Pharmacokinetics: Maximum Concentration (Cmax) for Merestinib for Standard Meal and Fasted State
Predose through 120 hours after administration of study drug
Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for High-Fat Meal and Fasted State
Predose through 120 hours after administration of study drug
Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for Standard Meal and Fasted State
Predose through 120 hours after administration of study drug
Secondary Endpoints
Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State
Predose through 120 hours after administration of study drug
Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for Standard Meal and Fasted State
Predose through 120 hours after administration of study drug
Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State
Predose through 120 hours after administration of study drug
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Merestinib FastedEXPERIMENTALSingle dose of merestinib administered in fasted state in one of three periods
Merestinib Standard MealEXPERIMENTALSingle dose of merestinib administered with a standard meal in one of three periods
Merestinib High-Fat MealEXPERIMENTALSingle dose of merestinib administered with a high-fat meal in one of three periods
Interventions
NameTypeDescription
MerestinibDRUGAdministered orally
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Generally healthy sterile male and female participants * Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive * Are willing and able to eat the protocol specified high-fat breakfast Exclusion Criteria: * Have consumed grapefruits or grapefruit-...

Countries:United States
Unlock Eligibility Criteria