ACTRN12623000696695已完成1 期
A Randomized, Double-Blind and Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIR9900 after Oral Administrations in Healthy Adult Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •Potential participants must fulfil all the following inclusion criteria to be eligible for the study:
- •1. Are capable of signing the Participant Informed Consent Form (PICF) and complying with study procedures.
- •2. Male or female healthy participants between the ages of 18 and 64 years old, inclusive, for healthy adult volunteer cohorts.
- •3. Women of childbearing potential (WOCBP) must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1 percent with a barrier contraceptive (such as condom) during the study and for 30 days after discontinuation of study treatment. Unless she is exclusively in same-sex relationships. Women are considered not of childbearing potential if they are surgically sterile (i.e., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy tubal ligation) or greater than 1 year postmenopausal.
- •4. All male participants with female partners of childbearing potential must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1 percent with a barrier contraceptive (such as condom) , and must agree to abstain from sperm donation during and for 90 days after participation in the study. Unless he is exclusively in same-sex relationships.
- •5. Considered healthy by the Principal Investigator (PI) or delegate, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs.
- •6. Non-smoker/Social smoker, defined as not having smoked more than 5 cigarettes or equivalent per day in the last 3 months before screening. During screening till the end of the confinement period, participant must be able to and must agree to abstain from the use of nicotine/tobacco containing products. Positive result of cotinine screen at admission will be excluded.
- •7. Able to abstain from the consumption of alcohol and any alcohol-containing products from 48 hours before dosing to the end of the confinement period
- •8. Able to abstain from the consumption of coffee and any caffeine-containing products from 48 hours before dosing to the end of the confinement period.
- •9. Body mass index (BMI) of 18 to 30 kg/m2 inclusive and body weight not less than 50 kg.
- •10. Willing and able to adhere to study restrictions and to be confined at the clinical research unit.
排除标准
- •Potential participants will be excluded from study entry if any of the following exclusion criteria are present at screening or admission:
- •1. Clinically significant haematological findings at screening.
- •2. Abnormal findings indicating hepatic impairment, such as aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase greater than or equal to 1.5 times upper limit of normal (ULN), total bilirubin greater than ULN, albumin less than or equal to 3 g/dL, serum amylase or lipase greater than or equal to 1.5 times ULN at screening.
- •3. Abnormal findings indicating renal impairment, such as creatinine greater than or equal to 1.5 times ULN, estimated glomerular filtration rate of 80 mL/minute/1.73m2 or less calculated by the Cockcroft-Gault formula, at screening.
- •4. Clinically significant ECG findings including QTcF value greater than 450 ms for male or greater than 470 ms for female at screening/pre-dose day 1.
- •5. Participants with a mean systolic blood pressure (SBP) of three measurements greater than 140 mmHg, or a mean diastolic blood pressure (DBP) of three measurements greater than 90 mmHg at screening. Blood pressure will be measured at sitting position at screening.
- •6. Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) at screening or at any time during the screening period pre-dose.
- •7. A history of seizure. However, a history of febrile seizure is allowed.
- •8. Positive results of pregnancy test at screening or admission. Pregnant or breast feeding, lactating, or planning to become pregnant, breast feed or donate ova during the study and within 30 days after the study.
- •9. A hospital admission or major surgery within 60 days prior to screening and/or planned surgery for the duration of the study and follow up period.
- •10. Receipt of any other investigational drug product within 30 days or 5 half-lives of the other investigational drug (whichever is longer) prior to dosing.
- •11. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-V) substance use disorders and alcohol abuse within 12 months prior to screening and/or positive alcohol breath test at screening or admission.
- •12. A positive result for drugs of abuse at screening or admission. One repeat test will be allowed if false positive is considered by the PI or designee.
- •13. An unwillingness or inability to comply with food and beverage restrictions during study participation, including consumption of grapefruit (or pomelo or start fruit) or grapefruit juice, Seville oranges, Seville orange marmalade or other products containing grapefruit, pomelo, star fruit or Seville oranges within 7 days before dosing and until final discharge from the CRU.
- •14. Donation or blood collection of more than 1 unit (approximately 450 mL) of blood (or blood products) or acute loss of blood during the 30 days prior to screening and/or planning to donate blood during the study and follow up period.
- •15. For participants aged up to and including 64 years, use of prescription or non-prescription drugs (contraceptives are permitted), including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days, or 14 days if the drug is a potential index substrate for CYP450 isoform 1A2, or inhibitor/inducer of isoforms 3A4 or 2C8 enzymes, or 5 half- lives (whichever is longer) prior to dosing. These medications are also prohibited during the study except for th
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