Amyotrophic lateral sclerosis (ALS) Nervous System Diseases Motor neuron disease
Conditions
Interventions
This is a single-centre, randomised, open-label, crossover Phase I study in healthy adult volunteers to assess the effect of food on the pharmacokinetics (PK) of CORT113176 when given by mouth as soft
the other group will take 300 mg CORT113176 (4 x 75 mg softgel capsules).
Blood samples will be taken before, and frequently after, dosing to measure the amount of CORT113176.
Sponsors
Corcept Therapeutics (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects or non-pregnant, non-lactating healthy female subjects of non-childbearing potential (women of non-childbearing potential, as defined in the clinical protocol) 2. Age 18 to 60 years at the time of signing informed consent 3. Body mass index of 18.0 to 30.0 kg/m² as measured at screening 4. Weight of =102 kg at screening 5. Must be willing and able to communicate and participate in the whole study 6. Must provide written informed consent 7. Must agree to adhere to the contraception requirements defined in the clinical protocol
Exclusion criteria
Exclusion criteria: 1. Subjects who have received any investigational medicinal product (IMP) in a clinical research study within the 90 days before the first dose in this study, or less than 5 elimination half-lives prior to the first dose, whichever is longer 2. Subjects who are, or are immediate family members of, a study site or Sponsor employee 3. Subjects who have previously been administered IMP in this study. 4. Evidence of current SARS-CoV-2 infection or required to self-isolate in accordance with current government guidelines 5. History of any drug or alcohol abuse in the past 2 years 6. Regular alcohol consumption in male subjects >21 units per week and female subjects >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 ml glass of wine, depending on type) 7. A confirmed positive alcohol breath test at screening or admission 8. Current smokers and those who have smoked within the last 6 months before the first dose in this study. A confirmed breath carbon monoxide (CO) reading of greater than 10 ppm at screening or admission 9. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months before the first dose in this study 10. Female subjects of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative pregnancy test at screening and admission). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone concentration =40 IU/L). 11. Male subjects with pregnant or lactating partners 12. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator or delegate at screening 13. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the Investigator. Subjects with Gilbert’s syndrome are allowed 14. Confirmed positive drugs of abuse test result 15. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results 16. Subject has active renal and/or hepatic disease, as evidenced by: 16.1. An estimated glomerular filtration rate (eGFR) of 1.5 times the upper limit of normal at screening or on admission 16.3. Subjects with borderline results can have these tests repeated once 17. History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal (GI), neurological or psychiatric disorder, as judged by the Investigator 18. Subject had any form of cancer within the 5 years before the first dose in this study, with the exception of basal cell and/or squamous cell cancer of the skin that has been treated completely and is without evidence of local recurrence or metastasis 19. Subject has a history and/or symptoms of adrenal insuff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) characteristics calculated from levels of CORT113176 measured using high-performance liquid chromatography (HPLC) analysis of blood samples collected throughout the trial between screening and day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Participant-identified adverse events assessed by questionnaire throughout the trial between screening and day 7 2. Other safety events identified by standard Phase I facility monitoring (blood test, clinical laboratory tests, urine samples, safety labs, ECG and physical examination findings) throughout the trial between screening and day 7 | — |
Countries
England, United Kingdom
Outcome results
None listed