Recent Updates
Recently added Catalysts

LY3314814

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Oct 31, 2019

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03222427A Study of LY3314814 in Healthy ParticipantsPHASE1 COMPLETED 8Jan 15, 2018Feb 16, 2018Oct 31, 20191 United Kingdom
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Absolute Bioavailability of LY3314814
Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose

Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered \[13C415N3\]-LY3314814.

Secondary Endpoints
Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814
Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3314814EXPERIMENTALSingle 50 milligram (mg) dose of LY3314814 administered orally
[13C415N3] LY3314814EXPERIMENTALSingle 100 micrograms (μg) intravenous (IV) dose of \[13C415N3\] LY3314814 administered as an IV infusion.
Interventions
NameTypeDescription
LY3314814DRUGAdministered orally
[13C415N3] LY3314814DRUGAdministered as an IV infusion
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy males or females * Have venous access sufficient to allow for blood sampling and intravenous (IV) administration of the investigational product Exclusion Criteria: * Have a history of significant ophthalmic disease * Have vitiligo or any other clinically ...

Countries:United Kingdom
Unlock Eligibility Criteria