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LY3050258

Phase 1

Healthy Participants | Small molecule | Other |Eli Lilly and Company|Last Updated: Aug 27, 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 Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01929707A Study of LY3050258 in Healthy ParticipantsPHASE1 COMPLETED 38 — — Aug 1, 2013Dec 1, 2013Aug 27, 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 up to 21 days postdose

Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.

Secondary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258
Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours (h) postdose and Day 7 postdose; Period 2: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258
Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Day 7 postdose; Period 2: predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3050258EXPERIMENTALSingle escalating dose of LY3050258 (2 milligram \[mg\] up to 200 mg) administered in up to two of two periods.
PlaceboPLACEBO_COMPARATORSingle dose of placebo matching LY3050258 administered in up to one of two periods.
Interventions
NameTypeDescription
LY3050258DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range30 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or healthy postmenopausal females, including Japanese participants * Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m\^2) Exclusion Criteria: * An abnormal sitting blood pressure as determined by the investigator * Any abnormality in th...

Countries:United States
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