NCT05707897已完成1 期
A Study to Assess the Food Effect of TS-142 in Healthy Subjects
适应症
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
- 12
- 试验地点
- 1
- 主要终点
- Plasma concentration
研究概览
简要总结
This is a study to assess the food effect of TS-142 preliminary market formulation tablet in healthy 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 male who are aged 18 years or older but less than 40 years at the time of informed consent
- •Body Mass Index (BMI) of 18.5 or more and less than 25.0 at the screening test
- •Subjects who are judged by the investigators as an eligible for the clinical trial participation based on the screening tests and the tests conducted at treatment period
- •Other protocol defined inclusion criteria could apply.
排除标准
- •Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
- •Subjects who have any unsuitable medical history for participation in this study, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrinological, metabolic, hematologic, immunologic, dermatological, neurological, or psychiatric diseases
- •Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts
- •Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
Fed condition
Experimental
Period in which subjects receive a single oral dose of TS-142 tablet in fed condition.
干预措施: TS-142 10 mg (Drug)
Fasted condition
Experimental
Period in which subjects receive a single oral dose of TS-142 tablet in fasted condition.
干预措施: TS-142 10 mg (Drug)
结局指标
主要结局
Plasma concentration
时间窗: Predose and up to 24 hours postdose
Plasma concentration of unchanged form and its metabolite
Pharmacokinetic parameters
时间窗: Predose and up to 24 hours postdose
Apparent total body clearance of unchanged form (CL/F)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Food Effect Study of TS-142 in Healthy SubjectsInsomniaJPRN-jRCT2071220103Mita Seiji12
已完成
1 期
Effect of Food on Blood Levels of ASTX727Myelodysplastic SyndromesAcute Myeloid LeukemiaChronic Myelomonocytic LeukemiaNCT03813186Astex Pharmaceuticals, Inc.18
已完成
1 期
The Effect of Food on the Pharmacokinetics of BN104 TabletsHealth SubjectsNCT06724549BioNova Pharmaceuticals (Shanghai) LTD.16
已完成
1 期
A Study of TAK-227 in Healthy AdultsHealthy VolunteersNCT05818956Takeda24
已完成
1 期
A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy AdultsHealthy SubjectNCT04023903Kyowa Kirin Co., Ltd.36