Mass Balance Recovery and Metabolite Profile of CORT125281 in Healthy Male Participants

Corcept Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: 14C-CORT125281

Study type

Interventional

Funder types

Industry

Identifiers

NCT03877952

CORT125281-602

2018-001700-11 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-CORT125281 in healthy participants.

Enrollment

6 patients

Sex

Male

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Have received any investigational medicine in a clinical research study within the previous 3 months, or CORT125281 at any time
Have a pregnant partner
Employees or immediate family members of employees of the study site or Sponsor
History of abuse of any drug or alcohol, or regularly consume more than 21 units alcohol/week
Smokers or users of e-cigarettes and nicotine replacement products within the last 6 months
Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017; greater than background radiation exposure from other sources exceeding 5 milliSieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
Clinically significant abnormal results of clinical laboratory safety tests, electrocardiogram, or measurement of heart rate and blood pressure
History of clinically significant cardiovascular, renal, hepatic, respiratory or gastrointestinal disease, neurological or psychiatric disorder
History and/or symptoms of adrenal insufficiency or any condition that could be aggravated by glucocorticoid blockade (e.g., an autoimmune disease; allergy requiring treatment)
Donation or loss of greater than 400 mL of blood within the previous 3 months
Are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies within 1 week (longer restrictions apply for some medicines).