Status:
COMPLETED
Mass Balance Recovery and Metabolite Profile of CORT125281 in Healthy Male Participants
Lead Sponsor:
Corcept Therapeutics
Conditions:
Healthy
Eligibility:
MALE
30-65 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03877952
Start Date
September 13 2018
End Date
November 2 2018
Last Update
March 18 2019
Active Locations (1)
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1
Quotient Sciences
Ruddington, Nottingham, United Kingdom, NG11 6JS