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-LY2801653

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Jan 9, 2014

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01981408A Study of LY2801653 in Healthy ParticipantsPHASE1 COMPLETED 6 — — Nov 1, 2013Dec 1, 2013Jan 9, 20141 United States
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Study Endpoints
Primary Endpoints
Urinary and Fecal Excretion of LY2801653 Radioactivity over Time expressed as a Percentage of the Total Radioactive Dose Administered
Pre-dose up to 14 days post dose
Secondary Endpoints
Plasma Pharmacokinetics of LY2801653 and Radioactivity Maximum Observed Concentration (Cmax)
Pre-dose up to 14 days post dose
Plasma Pharmacokinetics of LY2801653 and Radioactivity Time of Maximum Concentration (tmax)
Pre-dose up to 14 days post dose
Plasma Pharmacokinetics of LY2801653 and Radioactivity Area Under The Concentration-time Curve from zero to the last timepoint with a measurable Concentration (AUC 0 to tlast)
Pre-dose up to 14 days post dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
[^14C]-LY2801653EXPERIMENTALSingle oral dose of LY2801653 containing 100 micro curies of radioactivity
Interventions
NameTypeDescription
[^14C]-LY2801653DRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Generally healthy sterile male and female participants * Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m\^2), inclusive Exclusion Criteria: * Regularly use known drugs of abuse and/or show positive findings on urinary drug screening * Have cons...

Countries:United States
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