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LY3023703

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Dec 14, 2018

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 Enrollment78
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01849055A Multiple Dose Study of LY3023703 in Healthy ParticipantsPHASE1 COMPLETED 48 — — May 1, 2013Dec 1, 2013Dec 14, 20181 United States
NCT01632579A Single Dose Study of LY3023703 in Healthy ParticipantsPHASE1 COMPLETED 30 — — Jun 1, 2012Sep 1, 2012Aug 6, 20181 United States
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Study Endpoints
Primary Endpoints
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline to Study Completion (up to 74 Days)

A summary of serious and all other non-serious adverse events (AE), regardless of possible study drug relatedness, is located in the Reported Adverse Events module.

Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AE
Baseline up to Day 7 post-dose

AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible study drug relatedness, is located in the Reported Adverse Events module.

Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve [AUC(0-24)] of LY3023703
Post-First Dose on Days 1-28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.)
Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703
Post first dose on Day 1 through Day 28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.)
Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3023703
Post first dose on Day 1 through Day 28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo matching LY3023703 administered orally, once daily (QD), for 28 days
LY3023703EXPERIMENTALEscalating doses (2.5 milligram \[mg\] up to 30 mg) of LY3023703 administered orally, QD, for 28 days
CelecoxibACTIVE_COMPARATOR400 mg celecoxib administered orally, QD, for 28 days. (Positive control.)
400 mg CelecoxibACTIVE_COMPARATORPositive control. Single 400 mg dose of celecoxib administered orally, open label, on one occasion separated by at least a 3 week washout period.
Interventions
NameTypeDescription
PlaceboDRUGAdministered orally
LY3023703DRUGAdministered orally
CelecoxibDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy individuals based on the history and physical examinations as determined by the investigator * Are normotensive (defined as supine systolic blood pressure \[BP\] less than 140 millimeters of mercury \[mm Hg\] and diastolic BP less than 90 mm Hg without the use ...

Countries:United States
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