jRCT2071210091已完成不适用
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Doses of S-001000 by dose-titration method in Japanese Healthy Adult Male Subjects(twice-daily oral administration)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- AEs and adverse drug reactions (ADRs)
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
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •(1) Japanese healthy male aged >= 20 and <= 45 years at the time of informed consent.
- •(2) Subjects with screening body mass index (BMI) >= 18.5 kg/m2 to < 28.0 kg/m
- •(3) Subjects considered healthy by the investigator/subinvestigator based on the results of screening examination, and medical examination and all tests performed after admission and before study drug administration.
- •(4) Subjects who are fully informed of the study objectives, contents, and study drug, and voluntarily provide a written consent to participate in the study.
排除标准
- •(1)Subjects with a current or past history of a clinically concerned gastrointestinal, hepatic, musculoskeletal, respiratory, cerebrovascular or cardiovascular, hematological, oncological, endocrine, immunological, psychiatric, neurological, or urogenital disease, or any condition that, in the opinion of the investigator/subinvestigator, would compromise the subject's safety or interfere with this study results.
- •(2)Subjects with a current or past history of urinary calculus.
- •(3)Subjects with a history of surgery or a current internal medical condition that, in the opinion of the investigator/subinvestigator, may interfere with drug absorption, distribution, metabolism, or excretion.
- •(4)Otherwise, subjects who are judged by the investigator/subinvestigator to be ineligible for the study.
结局指标
主要结局
AEs and adverse drug reactions (ADRs)
Adverse events and adverse drug reactions
Laboratory values
Hematology, clinical chemistry, and urinalysis
Vital signs
Blood pressure, pulse rate, and body temperature
12-lead ECG
12-lead electrocardiogram
Pharmacokinetic Endpoints
Each PK parameter of unchanged S-001000 and its metabolites will be calculated from the plasma or urine drug concentration.
次要结局
未报告次要终点
研究者
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