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[14C-ETC-1002]

Phase 1

Hyperlipidemia | Unknown | Metabolic |Esperion Therapeutics, Inc.|Last Updated: Feb 15, 2019

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
NCT02044627Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002PHASE1 COMPLETED 6Dec 1, 2013Jan 1, 2014Feb 15, 20191 United Kingdom
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Study Endpoints
Primary Endpoints
Level of [14C]-ETC-1002 in urine and feces after a single dose
11 days

using mass balance recovery

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
1 dose of [14C-ETC-1002]EXPERIMENTAL -
Interventions
NameTypeDescription
[14C-ETC-1002]DRUG -
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Eligibility Criteria
Age Range30 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Male Volunteers * BMI 10-35 kg/m2 Exclusion Criteria: * Hx of CV, renal, hepatic, chronic respiratory or GI disease * Hx of drug or alcohol abuse * smoking within 12 mos of screening

Countries:United Kingdom
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