Healthy
Conditions
Brief summary
This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of \[14C\]-CORT113176 in healthy male participants.
Interventions
DRUG[14C]-CORT113176
\[14C\]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C.
Sponsors
Corcept Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mass Balance Recovery in Excreta After a Single Dose of [14C]-CORT113176 | Until the mass balance criteria for all participants have been met (estimated up to 28 days) |
Secondary
| Measure | Time frame |
|---|---|
| Mass Balance Recovery in Feces After a Single Oral Dose of [14C]-CORT113176 | Until the mass balance criteria for all participants have been met (estimated up to 28 days) |
| Number of CORT113176 Metabolites Accounting for ≥10% of Total Circulating Radioactivity or ≥10% of Dose Excreted in Urine and Feces | Until the mass balance criteria for all participants have been met (estimated up to 28 days) |
| Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax) | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of Total Radioactivity after Oral Dosing: Time from Dosing to Cmax (Tmax) | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of Total Radioactivity after Oral Dosing: Area Under the Plasma Concentration-time Curve from Zero Time to Time of the Last Measurable Concentration (AUC0-last) | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of Total Radioactivity after Oral Dosing: Apparent Elimination Half-life (t1/2) | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Mass Balance Recovery in Urine After a Single Oral Dose of [14C]-CORT113176 | Until the mass balance criteria for all participants have been met (estimated up to 28 days) |
| Plasma PK of CORT113176 after Oral Dosing: Tmax | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT113176 after Oral Dosing: AUC0-last | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT113176 after Oral Dosing: t1/2 | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing | Before dosing and at pre-specified time points up to Day 8 after dosing |
| Number of Participants with One or More Adverse Events | Until the mass balance criteria for all participants have been met (estimated up to 28 days) |
| Plasma PK of CORT113176 after Oral Dosing: Cmax | Before dosing and at pre-specified time points up to Day 8 after dosing |
Countries
United Kingdom
Outcome results
None listed