A Clinical Pharmacological Study of TS-142 in Non-Elderly and Elderly Healthy Participants (A Repeated-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Elderly and Non-Elderly Participants)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
研究概览
简要总结
The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly and elderly participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Step1; No masking
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 and body weight is more than 40.0 kg at screening inspection
- •Other protocol defined inclusion criteria could apply
排除标准
- •History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant
- •History of drug and food allergy
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Step 1;TS-142
干预措施: Step 1: TS-142 (Drug)
Step 2;TS-142
干预措施: Step 2: TS-142 (Drug)
Step 2;TS-142
干预措施: Step 2: Placebo (Drug)
Step 2;Placebo
干预措施: Step 2: TS-142 (Drug)
Step 2;Placebo
干预措施: Step 2: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
时间窗: Day 1 up to Day 14
Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe
Area under the concentration-time curve AUC (tau)
时间窗: Day 1 up to Day 9
Concentration of TS-142 and its metabolites in plasma
Step2; Subjective Alertness via Karolinska Sleepiness Scale (KSS)
时间窗: Day 1 up to Day 8
Step2; as a measure of subjective alertness which is scored by 10 cm-VAS scale ranging from 1, extremely alert, to 9, extremely sleepy at the next morning after administration.
次要结局
未报告次要终点