NCT04979572已完成1 期
A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult 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
- 41
- 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
A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, 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
- •Japanese healthy males aged 20 years or older but less than 40 years at the time of informed consent
- •Those with a BMI of 18.5 or more and less than 25.0 at screening test
- •Those who are able to receive the explanation before participating in the study, understand the content of the study, and provide written informed consent by the subjects themselves.
排除标准
- •Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator.
- •Those who correspond to any of the following about bowel movements;
- •Repeated diarrhea (Bristol Stool Form Score [BSFS] score of 6 or higher) on a daily basis
- •Repeated constipation (no defecation for 2 days or more in a week) on a daily basis
- •Those who correspond to any of the following about bowel movements in the 7 days before administration;
- •Diarrhea on 2 or more days in 7 days
- •2 or more days without a bowel movement in 7 days
- •Those who have a history of gastrointestinal ulceration
- •Those who correspond to any of the following about infection;
- •Positive for SARS-CoV-2 in the nucleic acid amplification test performed at the time of admission
- •Suspected of having COVID-19
研究组 & 干预措施
Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg
Experimental
Single dose of TS-172 or placebo before breakfast
干预措施: TS-172 (Drug)
Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg
Experimental
Single dose of TS-172 or placebo before breakfast
干预措施: Placebo (Drug)
Part B (multiple dose) : Step 5: TS-172 90 mg
Experimental
Multiple dose of TS-172 or placebo before breakfast and dinner
干预措施: TS-172 (Drug)
Part B (multiple dose) : Step 5: TS-172 90 mg
Experimental
Multiple dose of TS-172 or placebo before breakfast and dinner
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)
时间窗: Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11
次要结局
- Concentration of unchanged form in plasma, urine and stool(Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11)
- Area under the plasma concentration-time curve (AUC) of unchanged form(Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11)
- Mean daily urinaly excretion of sodium and phosphorus(Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11)
- Mean daily Bristol Stool Form Scale (BSFS)(Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11)
研究者
研究点 (1)
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