ACTRN12621000400864已完成1 期
A randomized, open-label and two-way crossover study to evaluate the effects of SIR1-365 after a single oral dose of 300 mg on the activities of CYP450 isoform 3A in healthy young subjects
Sironax Australia Pty Ltd0 个研究点目标入组 20 人开始时间: 2021年4月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1.Are capable of signing informed consent form (ICF) and complying with study procedures;
- •2.Male or female healthy subjects between the ages of 18 and 45 years old, inclusive;
- •3.Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and be practicing a medically acceptable method of contraception with an annual failure rate of less than 1% during the study and 30 days after discontinuation of study treatment. Women are considered not childbearing potential if they are > 1 year postmenopausal or surgically sterile (ie, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy tubal ligation). If serum ßHCG is the standard of care, then this value can be used to determine eligibility. All male patients with female partners of child-bearing potential must use two acceptable methods of contraception (one of which must be a barrier method), during and for 90 days after participation in the study.
- •4.Considered healthy by the Principal Investigator (PI), based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs;
- •5.Nonsmoker, defined as not having smoked more than 2 cigarettes a day during the 6 months before screening.;
- •6.Able to abstain from the consumption of alcohol and any alcohol-containing products from 48 hours before dosing through the end of the in house confinement;
- •7.Able to limit the consumption of coffee and any caffeine-containing products to four cups a day during the study;
- •8.Body mass index (BMI) of (>18 but <30 kg/m2 inclusive and body weight not less than 50 kg;
- •9.Willing and able to adhere to study restrictions and to be confined at the clinical research center.
排除标准
- •1.Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
- •2.Clinically significant hematological findings at screening;
- •3.Abnormal findings indicating hepatic impairment, such as AST, ALT, alkaline phosphatase greater than or equal to 2 times upper limit of normal (ULN), total bilirubin greater than or equal to 2.0 times ULN, or albumin less than or equal to 3 g/dL at screening;
- •4.Abnormal findings indicating renal impairment, such as positive urine protein (defined as greater than or equal to 1+ on repeated testing), creatinine greater than or equal to 1.5 times ULN, at screening;
- •5.Clinically significant ECG findings such as QTc value greater than or equal to 450 ms for male or 470 ms for female at screening;
- •6.Subjects with a mean systolic blood pressure of three measurements >150 mmHg, or a mean diastolic blood pressure of three measurements >90 mmHg at screening. Blood pressure will be measured at sitting position;
- •7.Known or suspected malignancy, except adequately treated basal cell carcinoma;
- •8.Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) or nasopharynx swab test for SARS-CoV-2;
- •9.A history of seizure. However, a history of febrile seizure is allowed;
- •10.Positive pregnancy test result at screening and baseline, or plan to become pregnant within 30 days after the end-of-study if female;
- •11.A hospital admission or major surgery within 60 days prior to screening;
- •12.Participation in any other investigational drug trial within 30 days prior to screening;
- •13.DSM-V substance use disorders within 6 months prior to screening;
- •14.A positive result for alcohol or drugs of abuse at screening or admission. Repeat test will be allowed if false positive is considered by the PI;
- •15.An unwillingness or inability to comply with food and beverage restrictions during study participation;
- •16.Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 30 days prior to screening;
- •17.Use of prescription or over-the-counter medications (except paracetamol up to 24 hours prior to dosing), and herbal medicines (including St John’s Wort, herbal teas, garlic extracts) within 30 days prior to dosing;
- •18.A history of suicide attempt in the past 12 months and/or seen by the investigator as having a significant risk of suicide or homicide;
- •19.An unwillingness of male participants to use appropriate contraceptive measures if engaging in sex intercourse with a female partner of childbearing potential during the study and up to 30 days after discontinuation of study treatment. Sexual intercourse with pregnant or lactating women is prohibited.
- •20.Subject has a known or suspected hypersensitivity to benzodiazepines, SIR1-365 and any components of SIR1-365 tablets.
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