ISRCTN20653849进行中（未招募）1 期
An open label, single-dose, single-period study designed to assess the mass balance recovery, metabolite profile and metabolite identification of [14C]-CORT125329 in healthy male subjects
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •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)
排除标准
- •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
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