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-LY2157299

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Dec 4, 2013

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
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01965808A Study of LY2157299 in Healthy ParticipantsPHASE1 COMPLETED 16 — — Oct 1, 2013Dec 1, 2013Dec 4, 20131 United States
NCT01746004A Study of LY2157299 Monohydrate in Healthy VolunteersPHASE1 COMPLETED 8 — — Jan 1, 2013Feb 1, 2013Feb 15, 20131 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299
Pre-dose through 72 hours post-dose in each study period
Pharmacokinetics: Time of Maximum Observed Concentration (tmax) of LY2157299
Pre-dose through 72 hours post-dose in each study period
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2157299
Pre-dose through 72 hours post-dose in each study period
Urinary and Fecal Excretion of LY2157299 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Pre-dose through Day 15
Secondary Endpoints
Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Maximum Observed Concentration (Cmax)
Pre-dose through Day 14
Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Time of Maximum Observed Concentration (Tmax)
Pre-dose through Day 14
Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Area Under the Concentration-Time Curve from Time Zero to the Last Timepoint with a Measurable Concentration (AUC 0 to tlast)
Pre-dose through Day 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY2157299 (Fasted)EXPERIMENTALSingle dose of 150 mg LY2157299 administered orally in fasted state in one of two study periods.
LY2157299 (Fed)EXPERIMENTALSingle dose of 150 mg LY2157299 administered orally in fed state in one of two study periods.
[^14C]-LY2157299EXPERIMENTALSingle 150 mg oral dose of LY2157299 monohydrate containing 100 micro curies of \[\^14C\] labeled drug
Interventions
NameTypeDescription
LY2157299DRUGAdministered orally
[^14C]-LY2157299DRUG\[\^14C\]-LY2157299 monohydrate administered as oral solution
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Eligibility Criteria
Age Range21 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy sterile males or females * Are able to eat a high fat meal * No abnormal heart function or high blood pressure * No participation in a clinical trial within 30 days * No evidence of human deficiency virus (HIV), hepatitis C or hepatitis B Exclusion Criteria: * Have a...

Countries:United States
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