Medical condition: Solid tumours Medical condition in lay language: Solid tumours Therapeutic areas: Diseases [C] - Cancer [C04] Cancer
Conditions
Interventions
This is a 2-part study. Part 1 is a single-period, single-dose, open-label study in healthy male subjects. Part 2 is an open-label, part-randomised, 3-way crossover study in healthy male and female su
Sponsors
Corcept Therapeutics (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must provide written informed consent. 2. Must be willing and able to communicate and participate in the whole study. 3. Aged 30 to 65 years (Part 1) or aged 18 to 55 (Part 2) inclusive at the time of signing informed consent. 4. Must agree to adhere to the contraception requirements defined in the Clinical Protocol. 5. Healthy male subjects (Parts 1 and 2) or non-pregnant, non-lactating female subjects of non-childbearing potential (Part 2 only) according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG, and laboratory safety tests without any clinically significant abnormalities. Safety bloods, urinalysis, ECGs and vital signs are to be re-checked at admission/pre-dose. 6. Body mass index (BMI) of 18.0 to 30.0 kg/m² as measured at screening 7. Weight =50 kg at screening. 8. Must have regular bowel movements (i.e. average stool production of =1 and =3 stools per day) for Part 1 only.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 11/10/2024: 1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients. 2. Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. 3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the Investigator. 4. Acute diarrhoea or constipation in the 7 days before the predicted Day 1. If screening occurs > 7 days before Day 1, this criterion will be determined on Day 1. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day (Part 1 only). 5. Subject had any form of cancer within the 5 years before 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. 6. Subject has a history and/or symptoms of adrenal insufficiency. 7. Subject has a history of clinically significant gastrointestinal disease including gastroesophageal reflux disease, malabsorption syndrome, colon cancer, chronic colitis, Crohn’s disease, inflammatory bowel disease, gastroparesis, cholecystectomy, constipation, chronic diarrhoea, obstruction, gastrointestinal bleeding, and/or peptic ulcers. 8. Subject has any history of clinically significant recurrent back pain, as judged by the Investigator. 9. Subject has any history of clinically significant recurrent ear infections, including otitis externa, as judged by the Investigator. 10. Subject has any condition or history of any condition that could be aggravated by glucocorticoid antagonism (e.g., asthma, any chronic inflammatory condition and including autoimmune disease or rheumatic disease) or glucocorticoid activation (e.g., immunodeficiency, active infection). Subjects with inactive seasonal hay fever may be included. Subjects with childhood (aged less than 18 years) asthma may be included provided they have had no symptoms and required no treatment for at least 5 years. 11. Subjects who do not have suitable veins for multiple venepunctures/cannulations as assessed by the Investigator or delegate at screening. 12. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the Investigator. Subjects with Gilbert’s Syndrome are not allowed. 13. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results. 14. Evidence of renal impairment at screening, as indicated by an estimated glomerular filtration rate (eGFR) of <80 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI; 2009) equation. 15. Female subjects (Part 1) or female subjects of childbearing potential (Part 2) including those who are pregnant or lactating. A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or is post-menopausal (had no menses for 12 months without an alternative medical cause and a serum follicle stimulating hormone [FSH] concentration =40 IU/L) All female subjects must have a negative highly sensitive urine (or serum) pregnancy test. 16. Clinically significant ECG abnormalit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Assessment of mass balance measured using urine and faecal samples taken from Day 1 to Day 11, or until mass balance criteria are met Part 1: Metabolite profiling and structural identification measured using blood, urine and faecal samples taken from Day -1 until Day 11 Part 2: Pharmacokinetic parameters measured using blood samples taken from Day 1 until Day 5 of each period | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Pharmacokinetic parameters measured using urine and faecal samples taken from Day -1 until Day 11, or until mass balance criteria are met Part 1: Identification of the chemical structure of each metabolite measured using blood, urine and faecal samples taken from Day -1 until Day 11 Part 1: Exploration of oral pharmacokinetic parameters measured using blood samples taken from Day -1 until Day 11 Part 1: Evaluation of whole blood:plasma concentration ratios for total radioactivity measured using blood samples taken from Day 1 until Day 11 Parts 1 and 2: Safety and tolerability measured using the incidence of adverse events, physical examinations, and changes from baseline for vital signs, electrocardiograms and laboratory safety tests from Day -1 until the final follow-up visit | — |
Countries
United Kingdom
Contacts
Public ContactHazel Hunt
Outcome results
None listed