Antipsychotic-induced weight gain (AIWG) Not Applicable
Conditions
Interventions
This is a non-randomized, open-label, uncontrolled, single-dose trial. This trial consists of a single study period involving up to 6 healthy male subjects, aged between 45 and 70 years. Following con
Sponsors
Corcept Therapeutics (United States)
Eligibility
Sex/Gender
Male
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 45 to 70 years inclusive at the time of signing informed consent 4. Must agree to adhere to the contraception requirements defined in the clinical study protocol. 5. Healthy male subjects 6. Body mass index of 18.0 to 32.0 kg/m² as measured at screening 7. Must have regular bowel movements (i.e., average stool production of =1 and =3 stools per day)
Exclusion criteria
Exclusion criteria: 1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients; allergy to lidocaine 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 (GI) disease, neurological or psychiatric disorder, as judged by the Investigator 4. Subject had any form of cancer within the 5 years before screening for 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 5. Subject has a history and/or symptoms of adrenal insufficiency 6. Subject has a history of clinically significant GI disease including gastroesophageal reflux disease, malabsorption syndrome, colon cancer, chronic colitis, Crohn’s disease, inflammatory bowel disease, gastroparesis, cholecystectomy, constipation, chronic diarrhoea, obstruction, GI bleeding, and/or peptic ulcers 7. Subject has a condition that could be aggravated by glucocorticoid antagonism (e.g., asthma, any chronic inflammatory condition). 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 prior to screening 8. History of additional risk factors for torsades de pointes (e.g., heart failure, hypokalaemia, family history of long QT syndrome) 9. Undergone a lumbar puncture within 6 weeks before Day 1 10. Medical history or evidence of mass occupying lesion in brain or spinal cord or history of spinal cord injury, which could preclude the procedure of lumbar puncture and CSF collection 11. Evidence or history of clinically significant back pain, back pathology and/or back injury (e.g degenerative disease, spinal deformity or spinal surgery) that may predispose to complications or technical difficulties in the conduct of a lumbar puncture 12. Evidence or history of significant active bleeding or coagulation disorder 13. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator or delegate at screening 14. Evidence of SARS-CoV-2 infection within 2 weeks of IMP administration 15. Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the Investigator. Subjects with Gilbert’s Syndrome are allowed. 16. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results 17. Subject has active renal and/or hepatic disease as demonstrated by ALT and/or AST >1.5 times the upper limit of normal at screening or on admission 18. Evidence of renal impairment at screening, as indicated by an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 using Modification of Diet in Renal Disease (MDRD) equation/Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI; 2009) equation 19. Platelet count below lower limit of normal; prothrombin time and/or activated partial thro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total radioactivity (TR) measured using liquid chromatography-radio-detection with subsequent mass spectrometry on blood samples collected from Day 1 to Day 11 and urine and faecal samples collected from Day 1 to Day 11 2. Metabolite profiling, structural identification, and quantification analysis using blood samples from Day 1 to Day 5 and urine and faecal samples collected from Day 1 to Day 11. This may be extended until the mass balance criteria are met. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total radioactivity/metabolite profiling using liquid chromatography-radio-detection with subsequent mass spectrometry on urine and faeces collected from Day 1 to Day 11. This may be extended until the mass balance criteria are met. 2. Metabolic profiling and ID using liquid chromatography-radio-detection with subsequent mass spectrometry on blood samples collected from Day 1 to Day 5 3. TR and PK measured using liquid chromatography-radio-detection with subsequent mass spectrometry on blood samples collected from Day 1 to Day 11 4. Adverse events monitored from signing the informed consent form until the follow-up phone call. Subjects will undergo safety tests, ECGs, vital signs measurements and physical examinations at screening, and at intervals from admission until final discharge 5. Total radioactivity and concentration of drug in CSF sample measured using liquid chromatography/mass spectrometry, collected on Day 1 | — |
Countries
England, United Kingdom
Contacts
Public ContactHazel Hunt
Outcome results
None listed