NCT07084961已完成1 期
A Pharmacodynamic Study of TS-172 in Healthy Adult Male Subjects
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Urinaly excretion of phosphorus
研究概览
简要总结
An open-label, single-center, crossover study to evaluate the impact of administration timing of TS-172 on the pharmacodynamics in healthy adult male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese healthy adult males whose age is >=18 and <40 years at the time of obtaining informed consent
- •Subjects whose body mass index is >=18.5 and <25.0 at the screening test
- •Subjects who are judged by a principal investigator or a sub-investigator to be eligible for participation in the study based on the results at the screening test and before administration of the drugs used in the study
- •Subjects who have been informed of the clinical trial, understand the details of the trial, and give their written consent prior to participation in the trial
排除标准
- •Subjects with medical history ineligible for participation in the study such as of respiratory, cardiovascular, gastrointestinal, hepatic, renal, urologic, endocrine, metabolic, hematologic, immunologic, dermatologic, neurologic, or psychiatric diseases
- •Subjects with medical history of disease (e.g., stomach or intestinal ulcers) or surgery (e.g., gastrectomy, gastric bandage, gastric bypass) that may affect the absorption of the drugs used in the study
- •Subjects who have been hospitalized with any treatment or undergone surgery within 12 weeks prior to receiving the drugs used in the study
- •Subjects with medical history of drug allergies (limited to severe symptoms such as anaphylaxis) or significant allergic predispositions (e.g., asthma that requires treatment)
- •Subjects who have used medications (including over-the-counter drugs) within 2 weeks prior to receiving the drugs used in the study
研究组 & 干预措施
TS-172 20 mg (sequence A)
Experimental
干预措施: TS-172 (Drug)
TS-172 20 mg (sequence B)
Experimental
干预措施: TS-172 (Drug)
结局指标
主要结局
Urinaly excretion of phosphorus
时间窗: Up to 3 days postdose during each period
Urinaly excretion of sodium
时间窗: Up to 3 days postdose during each period
次要结局
未报告次要终点
研究者
研究点 (1)
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