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Drug

Phase 1

Healthy Male Volunteers | Unknown | Other |Eli Lilly and Company|Last Updated: Jul 3, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01577355A Study of LY2784544 in Healthy Male SubjectsPHASE1 COMPLETED 8 — — Apr 1, 2012Jun 1, 2012Jul 3, 20121 United States
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Study Endpoints
Primary Endpoints
Urinary and fecal excretion of LY2784544 radioactivity over time expressed as a percentage of the total radioactive dose administered
Predose up to 14 days post dose
Secondary Endpoints
Plasma pharmacokinetics of LY2784544 and radioactivity maximum observed concentration (Cmax)
Predose up to 14 days post dose
Plasma pharmacokinetics of LY27854544 and radioactivity time of maximum observed concentration (tmax)
Predose up to 14 days post dose
Plasma pharmacokinetics of LY2784544 and radioactivity area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC 0 to tlast)
Predose up to 14 days post dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
[C14]-LY2784544EXPERIMENTALSingle 30 mg oral dose containing 100 micro curies of LY2784544
Interventions
NameTypeDescription
DrugRADIATIONSingle 30 mg oral dose containing 100 micro curies of LY2784544
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Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy males as determined by medical history and physical examination * Will either be sterile or, if sexually active, agree to use a reliable method of birth control from the day before dosing until 3 months after the end of the study * Have a body mass index (BM...

Countries:United States
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