ACTRN12623000408684终止1 期
A Single Center, Randomized,open label,two-period,cross over study to evaluate the effects of Food on Pharmacokinetics of AC-201 (Part 2)
Accro Bioscience (Australia) Pty Ltd0 个研究点目标入组 16 人开始时间: 2023年4月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1. Are capable of giving informed consent and complying with study procedures;
- •2. Are between the ages of 18 and 60 years, inclusive;
- •3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg for male and 45 kg for female, and no more than 120 kg;
- •4. Female subjects have a negative serum pregnancy test result at screening and a negative urine pregnancy test result Day -1, and meet one of the following criteria:
- •Using highly effective method of contraception such as implants, injectables, oral contraceptives, intrauterine devices (IUDs), intrauterine hormone-releasing system (IUS) at least 3 months prior to screening and willing to continue the control for the duration of the study and until 1 month after dosing with the study drug.
- •Surgically sterile for at least 3 months prior to screening by one of the following means:
- •Bilateral salpingectomy (with or without oophorectomy)
- •Surgical hysterectomy
- •Vasectomized partner
- •Bilateral oophorectomy (with or without hysterectomy)
- •Postmenopausal, defined as the following:
- •Last menstrual period greater than 12 months prior to screening
- •Postmenopausal status confirmed by serum follicle stimulating hormone (FSH) level is
- •greater than or equal to 30 IU/L at screening;
- •5. Male subjects with female partners of child bearing potential must agree to use condoms and use highly effective method of contraception with female partner for the duration of the study and until 3 months after dosing with the study drug;
- •6. Subjects who are exclusively in same-sex relationships and abstain completely for the duration of study and 3 months after the last study treatment are exempt from the contraceptive requirements;
- •7. Considered healthy by the Investigator, based on subject’s reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
- •8. Willing and able to adhere to study restrictions and to be confined at the clinical research center.
排除标准
- •1. Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal (GI), hepatic, psychiatric, neurologic, immunologic, Gilbert’s Syndrome and allergic disease (including multiple clinically significant drug allergies or food intolerances; mild and inactive hayfever is permitted), or any other condition, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug; or place the subject at an unacceptable risk as a participant in this study; resolved childhood asthma, non-hospitalised depression and migraines are not exclusionary unless deemed clinically significant by the investigator;
- •2. Has had an acute illness considered clinically significant by the Investigator within 30 days prior to screening, minor colds are permitted;
- •3. Laboratory results (serum chemistry, hematology, coagulation, and urinalysis) outside the normal range at screening and Check-in and considered clinically significant in the opinion of the Investigator. Subjects must be excluded who meet the following laboratory values at the screening visit: Hb<115g/L (Female) and HB<125g/L (Male); Serum creatinine>1.5xULN; Aspartate aminotransferase >1.5xULN; Alanine aminotransferase >1.5xULN; Total bilirubin>1.5xULN; Triglycerides >2mmol/L. One retest of an exclusionary laboratory result is allowed at the discretion of the Investigator;
- •4. Taken any drug that inhibits or induces liver drug-metabolizing enzymes 30 days prior to screening; Excessive consumption of xanthine-rich diets (including chocolate, tea, coffee, cola, etc.) or other effects that affect the absorption, distribution, metabolism, excretion and other factors of the drug 2 days prior to study drug administration;
- •5. Clinically significant history with sequelae of gastrointestinal tract, liver, kidney, or other diseases known to interfere drug absorption, distribution, metabolism or excretion (appendicectomy allowed if uncomplicated, hernia surgery allowed if small and no bowel resection, cholecystectomy excluded, bariatric surgery including gastric banding excluded);
- •6. Prolongation of QTcF (>450 msec for males and >470 msec for females) at screening;
- •7. eGFR <80mL/min calculated using Cockroft & Gault formula;
- •8. Cancer or history of lymphoproliferative disease within last 5 years; exception is resected cutaneous basal cell or squamous cell carcinoma that has been treated without recurrence;
- •9. Positive blood screen for hepatitis C antibody, hepatitis B surface antigen or human immunodeficiency virus (HIV) antibody;
- •10. A hospital admission or major surgery within 90 days prior to screening;
- •11. A history of prescription drug abuse, or illicit drug use within 3 months prior to screening;
- •12. A history of alcohol abuse according to medical history (drinking 4 or more standard drinks (a standard drink equals 10 g of pure alcohol) on any day for women and drinking 5 or more standard drinks on any day for men) within 3 months prior to screening;
- •13. Has more than 10 cigarettes/week within 30 days prior to screening or intends to use any product containing nicotine during the course of the study;
- •14. A positive screen for alcohol, and/or drugs of abuse at screening or Day -1; A positive screen for cotinine on Day -1; A repeat is allowed at investigator discretion for suspected false positive;
- •15. Unwilling to refrain from ingestion of dragon fruit, mango, grapefruit, grapefruit juice
研究者
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