ISRCTN52169163已完成1 期
A Phase I single-dose study to evaluate the pharmacokinetics of CORT113176 softgel capsules in healthy subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
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
- All
入选标准
- •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
排除标准
- •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 <60 mL/min/1.73 m² using Modification of Diet in Renal Disease (MDRD) equation at screening
- •16.2. ALT and/or AST >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
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