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14C-CORT125281

Phase 1

Undisclosed | Small molecule | Other |Corcept Therapeutics Incorporated|Trials Updated: Mar 18, 2019

14C-CORT125281 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

14C-CORT125281 clinical trials

14C-CORT125281 · 1 trial · 1 indication

Phase 1 1
NCT03877952Mass Balance Recovery and Metabolite Profile of CORT125281 in Healthy Male ParticipantsHealthy
COMPLETED6 Analytics
PHASE1COMPLETED
Mass Balance Recovery and Metabolite Profile of CORT125281 in Healthy Male Participants
HealthyUnlock trial analytics

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 to 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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Frequently asked questions about 14C-CORT125281

What is 14C-CORT125281?

14C-CORT125281 is a small molecule drug candidate developed by Corcept Therapeutics Incorporated. It has been studied in a Phase 1 clinical trial in healthy male participants. The compound is a carbon-14 labeled version of CORT125281, used to study how the drug is absorbed, metabolized, and excreted in the body.

Who is developing 14C-CORT125281?

14C-CORT125281 is being developed by Corcept Therapeutics Incorporated, which trades on the Nasdaq under the ticker CORT. The company sponsored the Phase 1 trial of the compound. Corcept is a biopharmaceutical company focused on the development of drugs that modulate the cortisol receptor pathway.

What phase is 14C-CORT125281 in?

14C-CORT125281 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug has not been approved by the FDA and remains investigational. Phase 1 trials typically assess safety, tolerability, and pharmacokinetics in a small number of participants.

What clinical trials is 14C-CORT125281 in?

14C-CORT125281 has been studied in one completed Phase 1 trial, NCT03877952, titled Mass Balance Recovery and Metabolite Profile of CORT125281 in Healthy Male Participants. The trial enrolled 6 healthy male participants in the United Kingdom. It was an uncontrolled, non-randomized study designed to characterize the drug's metabolism and excretion.

Is 14C-CORT125281 the same as CORT125281?

14C-CORT125281 is a carbon-14 radiolabeled form of CORT125281. The radiolabel allows researchers to track the drug's absorption, distribution, metabolism, and excretion in the body. The Phase 1 trial NCT03877952 specifically used this labeled version to study mass balance recovery and the metabolite profile of CORT125281.