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Axiron

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Aug 19, 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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02004132A Study of Axiron® in Healthy ParticipantsPHASE1 COMPLETED 12Dec 1, 2013Dec 1, 2013Aug 19, 20141 United States
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Study Endpoints
Primary Endpoints
Amount of Testosterone on T-shirts
12 hours after application of study drug

This is a summary of the amounts of testosterone measured on a 10 centimeters (cm) × 10 cm of material excised from the underarm area of participant's unwashed t-shirt halves.

Secondary Endpoints
Amount of Testosterone Following Laundering
12 hours after application of study drug
Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts
12 hours after application of study drug
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AxironEXPERIMENTALAxiron administered topically via metered dose pump to each underarm on Day 1
Interventions
NameTypeDescription
AxironDRUGSolution administered topically using pump and applicator
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy males, as determined by medical history and physical examination, or males who have been on stable medication for at least 1 month and have no significant clinical conditions. * Agree to use a reliable method of birth control (for example: condom or vasecto...

Countries:United States
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