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-CORT125281 in healthy participants.
Interventions
DRUG14C-CORT125281
14C-CORT125281 360 mg capsule for oral administration containing not more than 2.5 megaBequerel (67 μCi) 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 * 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mass Balance Recovery in Excreta After a Single Oral Dose of 14C-CORT125281 | Until the mass balance criteria for all participants have been met (estimated up to 10 days) |
Secondary
| Measure | Time frame |
|---|---|
| Mass Balance Recovery in Feces After a Single Oral Dose of 14C-CORT125281 | Until the mass balance criteria for all participants have been met (estimated up to 10 days) |
| Plasma Pharmacokinetics (PK) of Total Radioactivity after Oral Dosing: Peak Plasma Concentration (Cmax) | Pre-dose 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) | Pre-dose 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) | Pre-dose 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) | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of Total Radioactivity after Oral Dosing: Mean Residence Time (MRT) | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT125281 after Oral Dosing: Cmax | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Mass Balance Recovery in Urine After a Single Oral Dose of 14C-CORT125281 | Until the mass balance criteria for all participants have been met (estimated up to 10 days) |
| Plasma PK of CORT125281 after Oral Dosing: AUC0-last | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT125281 after Oral Dosing: t1/2 | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Plasma PK of CORT125281 after Oral Dosing: MRT | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Distribution of Total Radioactivity into Red Blood Cells after Oral Dosing | Pre-dose and at pre-specified time points up to Day 8 after dosing |
| Number of CORT125281 Metabolites Accounting for ≥10% of Total Radioactivity Detected in Plasma, Urine, and Feces | Until the mass balance criteria for all participants have been met (estimated up to 10 days) |
| Percentage of Participants with One or More Adverse Events | Until the mass balance criteria for all participants have been met (estimated up to 10 days) |
| Plasma PK of CORT125281 after Oral Dosing: tmax | Pre-dose and at pre-specified time points up to Day 8 after dosing |
Countries
United Kingdom
Outcome results
None listed