A Phase I Study of TS-142 in Non-Elderly Healthy Participants (Single Doses) (A Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Non-Elderly Participants)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve AUC (tau)
研究概览
简要总结
The purpose of this study is to investigate the safety and pharmacokinetics of single dosing of TS-142 to healthy Japanese non-elderly participants in fasting and after meal condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 at screening inspection
排除标准
- •History of clinically relevant disease of some organ systems that may be considerd inappropriately for this study
- •History of drug and food allergy
研究组 & 干预措施
TS-142, 1 mg
fasting
干预措施: 30 mg of TS-142 (Drug)
Arm Title: Placebo (fasting)
fasting
干预措施: Placebo (fasting) (Drug)
Arm Title: Placebo (fasting)
fasting
干预措施: 1 mg of TS-142 (Drug)
Arm Title: Placebo (fasting)
fasting
干预措施: 3 mg of TS-142 (Drug)
Arm Title: Placebo (fasting)
fasting
干预措施: 10 mg of TS-142 (fasting) (Drug)
Arm Title: Placebo (fasting)
fasting
干预措施: 30 mg of TS-142 (Drug)
Placebo (feeding)
after meal
干预措施: Placebo (feeding) (Drug)
Placebo (feeding)
after meal
干预措施: 10 mg of TS-142 (feeding) (Drug)
TS-142, 1 mg
fasting
干预措施: Placebo (fasting) (Drug)
TS-142, 1 mg
fasting
干预措施: 3 mg of TS-142 (Drug)
TS-142, 1 mg
fasting
干预措施: 10 mg of TS-142 (fasting) (Drug)
TS-142, 3 mg
fasting
干预措施: 1 mg of TS-142 (Drug)
TS-142, 3 mg
fasting
干预措施: 3 mg of TS-142 (Drug)
TS-142, 3 mg
fasting
干预措施: 10 mg of TS-142 (fasting) (Drug)
TS-142, 10 mg (feeding)
after meal
干预措施: 10 mg of TS-142 (fasting) (Drug)
TS-142, 3 mg
fasting
干预措施: 30 mg of TS-142 (Drug)
TS-142, 10 mg (fasting)
fasting
干预措施: Placebo (fasting) (Drug)
TS-142, 10 mg (fasting)
fasting
干预措施: 1 mg of TS-142 (Drug)
TS-142, 30 mg
fasting
干预措施: 30 mg of TS-142 (Drug)
TS-142, 10 mg (fasting)
fasting
干预措施: 3 mg of TS-142 (Drug)
TS-142, 10 mg (fasting)
fasting
干预措施: 10 mg of TS-142 (fasting) (Drug)
TS-142, 10 mg (fasting)
fasting
干预措施: 10 mg of TS-142 (feeding) (Drug)
TS-142, 10 mg (fasting)
fasting
干预措施: 30 mg of TS-142 (Drug)
TS-142, 10 mg (feeding)
after meal
干预措施: Placebo (feeding) (Drug)
TS-142, 10 mg (feeding)
after meal
干预措施: 10 mg of TS-142 (feeding) (Drug)
TS-142, 30 mg
fasting
干预措施: Placebo (fasting) (Drug)
TS-142, 30 mg
fasting
干预措施: 1 mg of TS-142 (Drug)
TS-142, 30 mg
fasting
干预措施: 3 mg of TS-142 (Drug)
TS-142, 30 mg
fasting
干预措施: 10 mg of TS-142 (fasting) (Drug)
结局指标
主要结局
Area under the concentration-time curve AUC (tau)
时间窗: 48 hours
Concentration of TS-142 and its metabolites in plasma
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
时间窗: Day 1 up to Day 8
Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe
次要结局
未报告次要终点