Clinical pharmacology study of BBI608 - A randomized, double blind, placebo controlled single-oral dose ascending study in healthy male and female Japanese volunteers to investigate the tolerability, safety, pharmacokinetics, QT/QTc assessment of BBI608. - A randomized, double blind, single-oral dose study in healthy Japanese male volunteers to examine the effect of food with sequential design. - An open-label single-oral dose study in healthy non-Asian male volunteers to evaluate pharmacokinetics.

Sumitomo Dainippon Pharma. Co,.Ltd.0 个研究点目标入组 70 人开始时间: 2020年8月26日最近更新: 2023年10月17日

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 70

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Observational

入排标准

年龄范围: >= 20age old 至 <= 45age old（—）
性别: All

入选标准

•Subjects who met all of the following inclusion criteria were selected.
•1) Subjects who provided written voluntary informed consent after fully receiving and understanding the information including the study objectives, contents, expected drug effect and pharmacological action and risks, before participation in this study
•2) Subjects who were capable of and willing to fulfil the study requirements during participation in the study, undergo protocol-stipulated physical examination and other examinations, and report symptoms or other abnormalities
•3) Subjects aged between 20 and < 45 years at the time of informed consent
•4) For Part A to D, subjects who were confirmed at screening to be Japanese. For Part E, subjects who were confirmed at screening to be non-Asians.
•5) Subjects who were currently in good health condition (without any medically relevant abnormal findings) in the opinion of the Investigator or Subinvestigator on the basis of physical examination, vital signs, laboratory test values (hematology, biochemistry, and urinalysis) and 12-lead analog ECG
•6) Female subjects of childbearing potential must have had a negative pregnancy test at screening
•7) Female subjects of childbearing potential must have used appropriate measures of contraception from the time of informed consent until 30 days after last dosing of the study drug to avoid own pregnancy. Male subjects with female partners of childbearing potential must have used appropriate measures of contraception from the time of informed consent until 90 days after last dosing of the study drug to avoid pregnancy of female partner.
•8) Japanese male subjects must have had a body weight of >=50.0 kg and <=80.0 kg and a body mass index (BMI) of >=18.5 and < 25.0 at screening examination. Japanese female subjects must have had a body weight of >=40.0 kg and <=80.0 kg and a BMI of >=16.8 and < 25.0 at screening examination. Non-Asian male subjects must have had a body weight of >=50.0 kg and <=100.0 kg and a BMI of >=18.5 and < 30.0 at screening examination. BMI was calculated as follows: BMI = body weight (kg) / [height (m)]2
•9) Subjects whose education level was high enough to appropriately communicate with the Investigator, Subinvestigator and clinical research coordinators, and who understood Japanese or English

排除标准

•Subjects meeting any of the following criteria will be excluded from this study:
•1) Subjects with current or past history of significant disease such as cardiovascular, hematological, hemorrhagic, hepatic, renal, metabolic, endocrine, respiratory,
•gastrointestinal, urological, neurological, central nervous system or psychoneurological disease or allergic disease (with the exception of asymptomatic, untreated seasonal allergy at the time of screening examination) that is inappropriate for participation in the study in the opinion of the Investigator
•2) Subjects who currently have any medical problem (requiring certain treatment or follow-up observation) in the opinion of the Investigator on the basis of physical examination and other examinations (except for centrally assessed ECG parameters) performed at screening, on the day before administration of the study drug, or at pre-dose on the day of administration of the study drug
•3) Subjects with a risk factor for torsade de pointes, such as a family history of long QT syndrome or sudden death in immediate family members (ie, biological parents and siblings)
•4) Subjects with a history of cardiac failure or hypokalemia
•5) Subjects with screening 12-lead analog ECG demonstrating any of the following: heart rate (HR) < 50 bpm, HR > 100 bpm, QRS > 100 msec, Fridericia-corrected QT interval (QTcF) > 450 msec, or PR > 200 msec
•6) Subjects with a history of severe allergy or of allergy to two or more drugs. Subjects with a history of allergy to any ingredients in the study drug product. Subjects with known or suspected hypersensitivity to drugs.
•7) Subjects who received another study drug while in another clinical trial within 90 days before administration of the study drug in the present study
•8) Subjects who had been hospitalized within 45 days before administration of the study drug
•9) Subjects who donated blood or blood components as follows:
•a) 400 mL or more blood within 90 days before administration of the study drug
•b) 200 mL or more blood within 30 days before administration of the study drug
•c) Blood components within 14 days before administration of the study drug
•10) Subjects with a positive urine drug screen test at screening or with a positive immunology test at screening
•11) Subjects who used any prescription drug or over-the-counter drug during a specified time period before administration of the study drug (ie, five elimination half-lives of the drug or 14 days, whichever is longer), or who are anticipated to require any drugs during the study period (except for drugs to treat adverse events)
•12) Subjects who used any drugs that can induce drug-metabolizing enzymes within 30 days before administration of the study drug
•13) Subjects who consumed St. John's wort-containing foods or beverages within 14 days before administration of the study drug
•14) Subjects who consumed grapefruit-containing foods or beverages within 7 days before administration of the study drug
•15) Subjects with known or suspected alcohol abuse
•16) Subjects with high consumption of caffeine-containing beverages (e.g., coffee, black tea, green tea, cola, energy drinks)
•17) Subjects with a history of tobacco dependence. Subjects who used tobacco or nicotine-containing products (eg, pipes, cigars, nicotine patches, chewing tobacco, nasal spray, inhaler, nicotine gum) within 30 days before screening examination
•18) Subjects who do not tolerate venipuncture or have poor venous access that would cause difficulty for c

研究者

发起方

Sumitomo Dainippon Pharma. Co,.Ltd.

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