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14C-CORT125281

Phase 1

Healthy | Small molecule | Other |Corcept Therapeutics Incorporated|Last Updated: Mar 18, 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
NCT03877952Mass Balance Recovery and Metabolite Profile of CORT125281 in Healthy Male ParticipantsPHASE1 COMPLETED 6 — — Sep 13, 2018Nov 2, 2018Mar 18, 20191 United Kingdom
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Study Endpoints
Primary Endpoints
Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT125281
Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Secondary Endpoints
Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT125281
Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Mass Balance Recovery in Feces After a Single Oral Dose of 14C-CORT125281
Until the mass balance criteria for all participants have been met (estimated up to 10 days)
Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax)
Pre-dose and at pre-specified time points up to Day 8 after dosing
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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-CORT125281 360 mg (6 X 60 mg capsules) after an overnight fast.
Interventions
NameTypeDescription
14C-CORT125281DRUG14C-CORT125281 360 mg capsule for oral administration containing not more than 2.5 megaBequerel (67 μCi) 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 * Provide written informed consent * Have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day) * Able to swallow capsules * Adhere to specified contraception requirements. Exclusion Criteria: * H...

Countries:United Kingdom
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