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-CORT113176

Phase 1

Healthy | Small molecule | Other |Corcept Therapeutics Incorporated|Last Updated: Nov 24, 2021

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
NCT04990310Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C]-CORT113176 in Healthy Male ParticipantsPHASE1 COMPLETED 6 — — Aug 18, 2021Sep 20, 2021Nov 24, 20211 United Kingdom
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Study Endpoints
Primary Endpoints
Mass Balance Recovery in Excreta After a Single Dose of [14C]-CORT113176
Until the mass balance criteria for all participants have been met (estimated up to 28 days)
Secondary Endpoints
Mass Balance Recovery in Urine After a Single Oral Dose of [14C]-CORT113176
Until the mass balance criteria for all participants have been met (estimated up to 28 days)
Mass Balance Recovery in Feces After a Single Oral Dose of [14C]-CORT113176
Until the mass balance criteria for all participants have been met (estimated up to 28 days)
Number of CORT113176 Metabolites Accounting for ≥10% of Total Circulating Radioactivity or ≥10% of Dose Excreted in Urine and Feces
Until the mass balance criteria for all participants have been met (estimated up to 28 days)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Study ParticipantsEXPERIMENTALOn Day 1, participants will receive a single oral dose of \[14C\]-CORT113176 450 mg (3 X 150 mg lipid formulation capsules) in the fed state.
Interventions
NameTypeDescription
[14C]-CORT113176DRUG\[14C\]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C.
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Eligibility Criteria
Age Range30 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index 18.0 to 30.0 kg/m\^2, inclusive * Willing and able to participate in the whole study * Have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day) * Provide written informed consent * Adhere to the contraception requirements. Excl...

Countries:United Kingdom
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