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

A Phase 1 Open-label, Single-dose Study Designed to Assess the Mass Balance Recovery and Metabolite Profile and to Identify Metabolite Structures for [14C]-CORT125281 in Healthy Subjects

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.

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).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.