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14C-CORT125281

Phase 1

Healthy | Small molecule | Other |Corcept Therapeutics Incorporated|Last Updated: Mar 18, 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

Clinical trial landscape

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
Healthy
NCT038779526
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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 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 an investigational small molecule being developed by Corcept Therapeutics Incorporated. It is a radiolabeled form of CORT125281, used in a Phase 1 study to evaluate mass balance recovery and metabolite profile in healthy male participants. The drug is not approved and remains in clinical development.

What is 14C-CORT125281 used for?

14C-CORT125281 is used in a Phase 1 clinical trial to assess its mass balance recovery and metabolite profile in healthy male participants. The study, NCT03877952, was completed in the United Kingdom with 6 participants. It is an investigational drug and not approved for any therapeutic use.

Who makes 14C-CORT125281?

14C-CORT125281 is developed by Corcept Therapeutics Incorporated, a biopharmaceutical company traded under the ticker CORT. The company conducted a Phase 1 trial of this radiolabeled small molecule in healthy volunteers to study its metabolism and excretion.

What phase is 14C-CORT125281 in?

14C-CORT125281 is in Phase 1 clinical development. A single Phase 1 trial, NCT03877952, has been completed. The drug is investigational and has not been approved by regulatory authorities. No active trials are currently listed for this asset.

What clinical trials is 14C-CORT125281 in?

14C-CORT125281 was studied in one completed Phase 1 trial, NCT03877952, titled 'Mass Balance Recovery and Metabolite Profile of CORT125281 in Healthy Male Participants.' The study enrolled 6 healthy male volunteers aged 30 years and older in the United Kingdom. It was uncontrolled and not blinded.