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LY3000328

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: May 31, 2012

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_CONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01515358A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy ParticipantsPHASE1 COMPLETED 18Feb 1, 2012May 1, 2012May 31, 20121 Singapore
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Study Endpoints
Primary Endpoints
Number of participants with one or more drug related adverse events (AEs) or any serious AEs
Baseline to study completion (estimate 3 months)
Secondary Endpoints
Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328
Pre-dose up to Day 6 post-dose
Pharmacokinetics: Maximum concentration (Cmax) of LY3000328
Pre-dose up to Day 6 post-dose
Change in Cathepsin S (CatS) activity
Pre-dose, up to 48 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORSingle dose of placebo administered orally in 1 out of 3 study periods separated by at least a 7-day wash-out period between each dose.
LY3000328EXPERIMENTALSingle escalating dose of up to 300 mg/kg of LY3000328 administered orally in 2 out of 3 study periods separated by at least a 7 day wash-out period between each dose.
Interventions
NameTypeDescription
PlaceboDRUGAdministered orally
LY3000328DRUGAdministered orally
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Eligibility Criteria
Age Range35 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination

Countries:Singapore
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