A Phase 1 Repeated Dose Study of NPC-22 in Healthy Adult Males

Miyoshi Katsunori0 个研究点目标入组 16 人开始时间: 2021年6月29日最近更新: 2023年10月17日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 16

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: Interventional

入排标准

年龄范围: >= 20age old 至 < 40age old（—）
性别: Male

入选标准

•1) Subjects who have provided their own written informed consent
•2) Subjects aged >=20 and <40 years at the time of informed consent
•3) Subjects with body weight of >=50 kg and body mass index (BMI) (kg/m2) of >=18.5 and <25.0
•4) Subjects who were identified to have no health problem on physical examination, physical assessment, laboratory tests, or other examinations at screening by the principal investigator or a sub-investigator

排除标准

•1) Subjects who are suffering or have a history of any skin disease or skin abnormality at the site of study drug administration (postauricular area) that may prevent evaluation or are receiving treatment at the site of study drug administration that may prevent evaluation (e.g., topical corticosteroids)
•2) Subjects who are hypersensitive to scopolamine or atropine (belladonna alkaloid) or have a complication or a history of drug allergy
•3) Subjects with a complication or a history of drug abuse (use of an illicit drug) or alcohol dependence
•4) Subjects with a history of severe disease that may recur during the study period
•5) Subjects with any concurrent illnesses such as angle closure glaucoma, open angle glaucoma, benign prostatic hyperplasia, urinary retention, severe heart disease, congestive heart failure, arrhythmia, paralytic ileus, pyloric stenosis, ileus, ulcerative colitis, asthma, hyperthyroidism, epilepsy, hepatitis, liver dysfunction or kidney dysfunction (however excluding diseases that will not affect study evaluations such as pollinosis without manifestations and verruca)
•6) Subjects who received another study drug within 180 days prior to the start of study drug administration
•7) Subjects who donated blood of >=400 mL within 12 weeks, blood of >=200 mL within 4 weeks, or blood components within 2 weeks prior to the start of the study
•8) Subjects who used any medicinal product (including over the counter drugs except for topical products) or similar product like a dietary supplement (including health food) within 7 days prior to the start of study drug administration
•9) Subjects who took any food or beverage containing grapefruit or St. John's wort within 7 days prior to the start of study drug administration
•10) Subjects who took any alcohol or caffeine-containing beverage within 3 days prior to the start of study drug administration
•11) Subjects who smoked (used a product such as a cigarette, pipe, cigar, chewing tobacco, electronic cigarette, nicotine patch, or nicotine gum) within 90 days prior to the start of study drug administration, or do not agree to stop smoking during the study period
•12) Subjects who had a positive result for HBs antigen, HCV antibody, or HIV antigen/antibody, or a positive reaction to syphilis serology or urine drug test at screening
•13) Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator based on the 12-lead electrocardiogram at screening (e.g., Fridericia's corrected QT (QTcF) interval of >=450 ms)
•14) Subjects who have serum electrolyte levels (potassium, calcium, and magnesium) lower than the institutional reference values
•15) Subjects who have a familial history of Torsades de Pointes or long QT syndrome
•16) Subjects who had blood pressure, pulse rate, or body temperature at screening as specified below
•(1) Systolic blood pressure <90 mmHg or >=140 mmHg
•(2) Diastolic blood pressure <40 mmHg or >=90 mmHg
•(3) Pulse rate <50 beats/min or >=100 beats/min
•(4) Body temperature <35.0 degree or >=37.degree
•17) Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator by having a deviation from the institutional reference values
•Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator due to other reasons

研究者

发起方

Miyoshi Katsunori

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