ISRCTN14072771进行中（未招募）1 期
A Phase I pharmacokinetic assessment of zavacorilant softgel capsule formulation, including dose proportionality and food effect in healthy subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
- •Informed Consent and Compliance:
- •1. Must provide written informed consent
- •2. Must be willing and able to communicate and participate in the whole study
- •Demographics and Contraception:
- •3. Aged 18 to 60 years inclusive at the time of signing informed consent
- •4. Must agree to adhere to the contraception requirements defined in the Clinical Protocol
- •Baseline Characteristics:
- •5. Healthy male subjects and healthy female subjects of non-childbearing potential according to the assessment of the Investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG, and clinical laboratory tests without any clinically significant abnormalities.
- •6. Body mass index (BMI) of 18.0 to 30.0 kg/m2 as measured at screening
- •7. Weight 50-102 kg at screening
排除标准
- •Medical/Surgical History and Mental Health:
- •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. Hay fever is allowed unless it is active.
- •3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the Investigator. Gilbert’s syndrome is not permitted.
- •4. Subjects with a history of cholecystectomy or gallstones
- •Physical Examination:
- •5. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator or delegate at screening
- •Diagnostic Assessments:
- •6. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the Investigator (laboratory parameters are listed in the protocol). Subjects with Gilbert’s Syndrome are allowed.
- •7. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- •8. Evidence of renal impairment as indicated by:
- •8.1. An estimated glomerular filtration rate (eGFR) of <80 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) at screening
- •8.2. ALT and/or AST >1.5 times the upper limit of normal at screening
- •9. Female subjects of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative highly sensitive 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 [FSH] concentration =40 IU/L)
- •10. Clinically significant ECG abnormalities or vital sign abnormalities at screening or baseline (pre-first dose of IMP) including but not limited to:
- •10.1. QTcF > 450 msec based on a single ECG at screening and pre-(first) dose
- •10.2. Supine heart rate (HR) at rest of 40-100 bpm at screening and pre-(first) dose
- •10.3. BP outside the following ranges: diastolic BP 40-90 mmHg; systolic BP 90-140 mmHg at screening or before the first dose
- •10.4. ECGs and HR and BP can be retested twice in the supine position at intervals of approximately 5 minutes on a given day
- •Prior Study Participation:
- •11. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
- •12. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- •Prior and Concomitant Medication:
- •13. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before the first IMP administration. Exceptions may apply, as determined by the Investigator and agreed by the Sponsor, if each of the following criteria are met: medication with a short half-life if the washout is such that no pharmacodynamic activity is expected by the time of dosing with IMP; the use of medication does not jeopardise the safety of the trial subject; and the use of medication is not considered to interfere with the objectives of the study.
- •14. Subjects who are currently using glucocorticoids or have a history o
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