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LY2624803 -

Phase 1

Sleep Initiation and Maintenance Disorders | Small molecule | Other |Eli Lilly and Company|Last Updated: Jan 28, 2016

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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01784614A Study of LY2624803 in Japanese Participants With Transient InsomniaPHASE1 COMPLETED 24 — — Sep 1, 2009Mar 1, 2010Jan 28, 20161 Japan
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Study Endpoints
Primary Endpoints
Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo
8 hours in Periods 1, 2 and 3

WASO was calculated as total time in awake epochs between sleep onset time (first stage 2 epoch) and the end of the primary recording period (8 hours after lights -off). Data presented are Geometric Least Squares (LS) means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.

Secondary Endpoints
Latency to Persistent Sleep (LPS)
8 hours in Periods 1, 2 and 3
Total Sleep Time (TST)
8 hours in Periods 1, 2 and 3
PK: Maximum Plasma Concentration (Cmax) of LY2624803 After Single Oral Dose in Period 4
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
0.1 milligrams (mg) LY2624803EXPERIMENTALSingle dose of 0.1 mg LY2624803 administered orally in up to 2 of 4 treatment periods
1.0 mg LY2624803EXPERIMENTALSingle dose of 1.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods
3.0 mg LY2624803EXPERIMENTALSingle dose of 3.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods
6.0 mg LY2624803EXPERIMENTALSingle dose of 6.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods
PlaceboPLACEBO_COMPARATORSingle dose of placebo administered orally in up to 1 of 4 treatment periods
Interventions
NameTypeDescription
LY2624803 - SolutionDRUGAdministered orally as reconstituted solution
LY2624803 - CapsuleDRUGAdministered orally as a capsule
Placebo - SolutionDRUGAdministered orally as solution
Placebo - CapsuleDRUGAdministered orally as a capsule
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Eligibility Criteria
Age Range20 Years — 85 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy males or female Japanese * Women of child-bearing potential, who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study and for 3 months following the last dose ...

Countries:Japan
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