Recent Updates
Recently added Catalysts

LY2624803

Phase 1

Insomnia | Small molecule | Other |Eli Lilly and Company|Last Updated: Dec 22, 2011

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 Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01236105Effect of Activated Charcoal and Time of Dose on the Pharmacokinetics of LY2624803 in Healthy SubjectPHASE1 COMPLETED 21Oct 1, 2010Dec 1, 2010Dec 22, 20111 United Kingdom
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Area Under the Concentration-Time Curve (AUC) for LY2624803 and the Metabolite LSN2797276
Predose and up to Day 4

AUC from time 0, extrapolated to infinity, estimated for both LY2624803 and the metabolite LSN2797276.

Maximum Concentration (Cmax) for LY2624803 and the Metabolite, LSN2797276,
Predose and up to Day 4

Cmax estimated for both LY2624803 and the metabolite LSN2797276.

Secondary Endpoints
Time to Maximum Plasma Concentration (Tmax) for LY2624803 and the Metabolite, LSN2797276
Predose and up to day 4
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
6 mg LY2624803 Alone Morning DosingEXPERIMENTALParticipants received 6 milligrams (mg) LY2624803 alone orally (po) at approximately 0800 hours following an overnight fast.
6 mg LY2624803 Morning Dosing + Activated CharcoalEXPERIMENTALParticipants received 6 mg LY2624803 po at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
6 mg LY2624803 Alone Evening DosingEXPERIMENTALParticipants received 6 mg LY2624803 alone po at approximately 2200 hours following a 4-hour fast.
Interventions
NameTypeDescription
LY2624803DRUGAdministered orally (po), once.
Activated CharcoalOTHERAdministered po
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination. * Male subjects with female partners of child-bearing potential and female subjects of child-bearing potential, agree to use 2 reliable methods of contraception from the time of th...

Countries:United Kingdom
Unlock Eligibility Criteria