JPRN-jRCT2071210023招募中1 期
Clinical Pharmacology Study of EPI-589 (DA350101)
Hamatani Tatsuto0 个研究点目标入组 40 人开始时间: 2021年5月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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
- 年龄范围
- >= 20age old 至 <= 55age old（—）
- 性别
- Male
入选标准
- •1)Male Japanese or Caucasian subject between 20-55 years of age (inclusive) at the time of consent.
- •2)Subject who is fully informed and understands the objectives, procedures, anticipated drug effects/pharmacological action, and risks of the study and who voluntarily provides written consent to participate in the study.
- •3)Subject with a body weight of between 50.0 kg and 80.0 kg (Japanese) and 50.0 kg and 100.0 kg (Caucasian), and a body mass index of at least 16 kg/m2 but no more than 32 kg/m2 at screening (body mass index is defined as the subject's body weight in kilograms divided by the square of the subject's height in meters).
- •4) Subject who is able to comply with the study requirements, including all assessments, physical examination, and reporting of symptoms.
- •5)Male subject with female partners of childbearing potential must be practicing abstinence consistently in their lifestyle or be willing to use acceptable and effective birth control from the time of signing informed consent until at least 30 days after the last study drug administration.
- •6)Subject must possess an educational level and degree of understanding of English or Japanese that enables them to communicate suitably with investigators and study staff.
排除标准
- •1)Subject with a history of cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematological, respiratory, psychiatric, or neurologic disease, and who was considered ineligible for the study by the investigator.
- •2)Subject with a clinically significant abnormal 12-lead ECG that may jeopardize the subject's ability to complete the study, or a screening 12-lead ECG that demonstrated any one of the following:
- •-Heart rate > 100 bpm or < 50 bpm
- •-QRS interval > 120 msec
- •-QTcF > 450 msec (QTcF = QT/RR1/3)
- •-PR interval > 200 msec
- •3)Subject who has a history of drug allergy.
- •4)Subject with any allergy or hypersensitivity to Coenzyme Q10 or Vitamin E supplements.
- •5)Subject who has a positive immunology at screening.
- •6)Subject who has a clinically significant abnormality in hematology test or blood chemistry (serum) test, or urinalysis at screening.
- •7)Subject who has a history of excessive alcohol consumption (roughly defined as drinking at least 1.3 L of beer or 360 mL of sake daily).
- •8)Subject who ordinarily drinks large quantities (approximately 1.8 L daily or more) of caffeinated beverages (coffee, tea, green tea, cola, tonic drink, etc.).
- •9)Subject with a history of tobacco dependency or subject who smokes, on average, more than 20 cigarettes daily.
- •10)Subject who previously received EPI-589.
- •11)Subject who has participated in an investigational drug study and received any investigational drug within 90 days prior to screening visit, or who is currently participating in another clinical trial.
- •12)Subject with a history of hospitalization (unless due to tests) within 45 days prior to screening visit.
- •13)Subject with a disorder or history of a condition (such as malabsorption and gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion or a clinically significant abnormality of the hepatic or renal system.
- •14)Subject with a history of substance abuse including alcohol or drug, or a positive urine drug test at screening or on the day before the initial study drug administration (Day -1).
- •15)Subject who has a CK, myoglobin (serum and urine), AST, or ALT exceeding the upper limit of normal in blood chemistry (serum) test or urinalysis at screening, or who has a CK exceeding the upper limit of normal in blood chemistry (serum) test on the day before the initial study drug administration (Day -1).
- •16)Subject who has experienced significant blood loss or donated blood (> 400 mL) within 90 days or donated 200 mL of blood or more within 30 days prior to the initial study drug administration (Day 1). Subject who has donated blood components within 14 days prior to the initial study drug administration (Day 1) or intends to donate blood components or blood within 30 days after the last study visit.
- •17)Subject who consumed Coenzyme Q10 or Vitamin E supplements within 14 days prior to the initial study drug administration (Day 1).
- •18)Subject who consumed St. John's wort-containing foods or beverages within 14 days prior to the initial study drug administration (Day 1).
- •19)Subject who consumed grapefruit or grapefruit-containing juices within 7 days prior to the initial study drug administration (Day 1).
- •20)Subject who has used prescription or over-the-counter medications (including herbal supplements) within 14 days prior to the initial study drug administration (Day 1).
- •21)Subject who has consumed alcohol between the day before and the time of screening test or 2 days before t
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