A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body

Study Overview
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Brief Summary
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The study was designed to evaluate how CORT125134 is taken up, broken down and removed from the body when given as an oral capsule to healthy subjects.

Detailed Description
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The study was conducted to determine the recovery of [14C]-CORT125134 after the administration of a single oral dose of [14C]-CORT125134, to determine the routes and rate of elimination of [14C]-CORT125134 and associated radioactivity from the body, and to measure concentrations of radioactivity in the blood. Additional objectives of the study were to determine the chemical structure of each significant metabolite in plasma, urine and feces. Safety and tolerability were assessed.

Official Title
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An Open-label, Single-dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structures for [14C]-CORT125134 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: [14C]-CORT125134


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males or healthy females of non-childbearing potential (surgically sterilized or postmenopausal [defined as a woman of with at least a 12 month history of amenorrhea with a follicle-stimulating hormone (FSH) >40 international units per liter (IU/L) in the absence of a reversible medical iatrogenic cause]) Age 30 to 65 years of age A history of regular bowel movements (averaging ≥1 and ≤3 stools per day) Must be willing and able to communicate and participate in the whole study Must provide written informed consent Male participants must agree to use an adequate method of contraception Participants are willing to abide by the study restrictions Exclusion Criteria: Participation in a clinical research study within the previous 3 months Participants who have previously been enrolled in this study or participants who have previously been treated with CORT125134 History of any drug or alcohol abuse in the past 2 years Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 milliliter (mL) of 40% spirit or a 125 mL glass of wine) Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products. A breath carbon monoxide reading of greater than 10 parts per million (ppm) Females of childbearing potential (female participants must have a negative urine pregnancy test) Male Participants with pregnant partners Radiation exposure exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. The measurement includes exposure from the present study, and diagnostic x rays and other medical exposures, but excludes background radiation. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999. Positive drugs of abuse test result Participants who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 grams per day paracetamol) or herbal remedies in the 14 days before study drug administration. Hormone replacement therapy is not permitted

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]-CORT125134<br>Two capsules each containing 125 milligrams (mg) [14C]-CORT125134 administered to each participant on 1 occasion | Drug: [14C]-CORT125134<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of radioactivity eliminated in urine |  | Day 1 pre-dose to Day 8 post-dose | 
| Amount of radioactivity eliminated in feces |  | Day 1 pre-dose to Day 8 post-dose | 
| Amount of radioactivity eliminated in urine and feces |  | Day 1 pre-dose to Day 8 post-dose | 
| Cumulative amount of radioactivity eliminated in urine |  | Day 1 pre-dose to Day 8 post-dose | 
| Cumulative amount of radioactivity eliminated in feces |  | Day 1 pre-dose to Day 8 post-dose | 
| Cumulative amount of radioactivity eliminated in urine and feces |  | Day 1 pre-dose to Day 8 post-dose | 
| Pharmacokinetics (PK) of total radioactivity: lag time (tlag) |  | Day 1 pre-dose to Day 8 post-dose | 
| PK of total radioactivity: peak plasma concentration (Cmax) |  | Day 1 pre-dose to Day 8 post-dose | 
| PK of total radioactivity: time to reach maximum observed concentration (tmax) |  | Day 1 pre-dose to Day 8 post-dose | 
| PK of total radioactivity: area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast) |  | Day 1 pre-dose to Day 8 post-dose | 
| PK of total radioactivity: area under the plasma concentration-time curve from time zero to infinity (AUCinf) |  | Day 1 pre-dose to Day 8 post-dose | 
| PK of total radioactivity: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap) |  | Day 1 pre-dose to Day 8 post-dose | 
| PK of total radioactivity: first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve (lambda-z) |  | Day 1 pre-dose to Day 8 post-dose | 
| PK of total radioactivity: elimination half-life (t1/2) |  | Day 1 pre-dose to Day 8 post-dose | 
| Metabolic profiling and structural identification in plasma, urine and feces |  | Day 1 pre-dose to Day 8 post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematology |  | Screening, Day 1 pre-dose, Day 8 | 
| Clinical chemistry |  | Screening, Day 1 pre-dose, Day 8 | 
| Urinalysis |  | Screening, Day 1 pre-dose, Day 8 | 
| Blood pressure |  | Screening, Day 1 pre-dose and 2 hours post-dose, Day 8 | 
| Heart rate |  | Screening, Day 1 pre-dose and 2 hours post-dose, Day 8 | 
| Electrocardiogram |  | Screening, Day 1 pre-dose and 2 hours post-dose, Day 8 | 
| Percentage of subjects with adverse events |  | Screening to Day 28 | 
| Physical examination |  | Screening and Day 8 | 
| Tlag of CORT125134 |  | Day 1 pre-dose to Day 8 post-dose | 
| Cmax of CORT125134 |  | Day 1 pre-dose to Day 8 post-dose | 
| Tmax of CORT125134 |  | Day 1 pre-dose to Day 8 post-dose | 
| AUClast of CORT125134 |  | Day 1 pre-dose to Day 8 post-dose | 
| %AUCextrap of CORT125134 |  | Day 1 pre-dose to Day 8 post-dose | 
| AUCinf of CORT125134 |  | Day 1 pre-dose to Day 8 post-dose | 
| Lambda-z of CORT125134 |  | Day 1 pre-dose to Day 8 post-dose | 
| T1/2 of CORT125134 |  | Day 1 pre-dose to Day 8 post-dose | 
| Mean Residence Time (MRT) of CORT125134 |  | Day 1 pre-dose to Day 8 post-dose | 
| Apparent oral clearance (CL/F) of CORT125134 |  | Day 1 pre-dose to Day 8 post-dose | 
| Apparent volume of distribution (Vz/F) of CORT125134 |  | Day 1 pre-dose to Day 8 post-dose | 
| Number of metabolites >10% of circulating radioactivity in plasma |  | Day 1 pre-dose to Day 8 post-dose | 
| Number of metabolites >10% of the dose in urine |  | Day 1 pre-dose to Day 8 post-dose | 
| Number of metabolites >10% of the dose in feces |  | Day 1 pre-dose to Day 8 post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Absorption, distribution, metabolism, and excretion (ADME), Metabolism, Metabolite Profiling, Excretion