Status:
COMPLETED
Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants
Lead Sponsor:
Corcept Therapeutics
Conditions:
Healthy
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
This study will evaluate the absolute bioavailability of CORT118335 and determine the mass balance recovery, absorption, metabolism and elimination, and metabolite profile and identification of metabo...
Eligibility Criteria
Inclusion
- Age 18 to 65 years of age for Part 1 and 30 to 65 years of age for Part 2
- Body mass index of 18.0 to 30.0 kg/m\^2
- Provide written informed consent
- Have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day) for Part 2
- Adhere to the contraception requirements.
Exclusion
- Have received any investigational medicine in a clinical research study within the previous 3 months or CORT118335 at any time
- Employees or immediate family members of employees of the study site or Sponsor
- Have a pregnant partner
- 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, endocrine, metabolic, respiratory, neurological, or gastrointestinal disease
- 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 past 3 months
- Has consumed liquorice or other glycyrrhetic acid derivatives regularly in the past 6 months
- Are taking, or have taken, any prescribed, over-the-counter drug or vitamins/herbal remedies within 14 days (longer restrictions apply for some medicines).
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Key Trial Info
Start Date :
August 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03878264
Start Date
August 6 2018
End Date
March 24 2019
Last Update
June 11 2019
Active Locations (1)
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1
Quotient Sciences
Ruddington, Nottingham, United Kingdom, NG11 6JS