Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C]-CORT113176 in Healthy Male Participants

Corcept Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: [14C]-CORT113176

Study type

Interventional

Funder types

Industry

Identifiers

NCT04990310

CORT113176-651

2021-002544-78 (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]-CORT113176 in healthy male 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
Willing and able to participate in the whole study
Have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
Provide written informed consent
Adhere to the contraception requirements.

Exclusion criteria

Have received any investigational medicine in a clinical research study within 90 days
Are, or are immediate family members of, a study site or sponsor employee
Evidence of current severe acute respiratory syndrome (SARS-CoV-2) infection
History of any drug or alcohol abuse, or regularly consume >21 units alcohol per week
Current smoker or user of e-cigarettes and nicotine replacement products within the last 6 months
Have pregnant or lactating partners
Radiation exposure, exceeding 5 milliSieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
Clinically significant abnormal results of clinical chemistry, hematology or urinalysis as judged by the investigator
Confirmed positive drugs of abuse test result
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
Active renal and/or hepatic disease
History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal (GI) disease, neurological or psychiatric disorder
Any form of cancer within the last 5 years (exceptions apply)
History and/or symptoms of adrenal insufficiency
Condition that could be aggravated by glucocorticoid antagonism or activation
Donation of blood or plasma 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 herbal remedies (other than up to 4 g of paracetamol per day) within 14 days. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply on a case by case basis.
Currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months or 3 months for inhaled products
Additional criteria apply.