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LY2969822

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Feb 21, 2019

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 Trials1
Total Enrollment99
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02018887A Study of LY2969822 in Healthy ParticipantsPHASE1 COMPLETED 99 — — Dec 1, 2013Feb 1, 2015Feb 21, 20191 Singapore
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Study Endpoints
Primary Endpoints
Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline Through End of Study (up to Week 7)

A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.

Secondary Endpoints
Pharmacokinetics (PK): Maximum Plasma Concentration (Plasma Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747
All Cohorts: Day 1 - 0 Hours (H), 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohort 3: Day 10 - 0 H, 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohorts 3 - 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H
PK: Maximum Cerebrospinal Fluid Concentrations (CSF Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747
Cohort 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H
PK: Area Under the Drug Plasma Concentration Time Curve (Plasma AUC) of Prodrug LY2969822 and Active Metabolite LSN2934747
All Cohorts: Day 1 - 0 Hours (H), 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohort 3: Day 10 - 0 H, 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohorts 3 - 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY2969822 (Part A)EXPERIMENTALSingle dose of LY2969822 administered orally in 2 of 3 study periods.
Placebo (Part A)PLACEBO_COMPARATORSingle dose of placebo administered orally in 1 of 3 study periods.
LY2969822 (Part B)EXPERIMENTALLY2969822 administered orally for 14 days.
Placebo (Part B)PLACEBO_COMPARATORPlacebo administered orally for 14 days.
LY2969822 (Part C)EXPERIMENTALLY2969822 administered orally for 14 days.
Placebo (Part C)PLACEBO_COMPARATORPlacebo administered orally for 14 days.
Interventions
NameTypeDescription
LY2969822DRUGCapsules administered orally
PlaceboDRUGCapsules administered orally
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male participants must agree to use a reliable method of birth control in addition to having their partner use another method for the duration of the study and for 3 months after the last dose of LY2969822 * Female participants must not be of child-bearing potential * Particip...

Countries:Singapore
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