Clinical Study on Histamine H3 Receptor Occupancy of TS-091 by PET Examination in Healthy Adult Subjects
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
- H3 receptor occupancy
研究概览
简要总结
To evaluate the following items by PET examination in Japanese heathy adult male subjects who received single oral administration of TS-091 in an unblinded manner.
- Relationship between plasma concentration and H3 receptor-occupancy of TS-091
- Time course changes in H3 receptor-occupancy of TS-091
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects who met all of the following criteria.
- •Age: between ≥20 years and <40 years at the time of providing written consent for participation in the study.
- •Body mass index (BMI): ≥18.5 and <25.0 on the day of screening test.
- •Subject who received a prior explanation on the study and was able to understand its content and capable of providing voluntary written consent for participation in the study.
- •Other protocol defined inclusion criteria could apply-
排除标准
- •Subjects who came under any of the following exclusion criteria.
- •Subjects who were considered to have some disease and not healthy by the investigator or subinvestigator according to his medical judgment based on the results of screening test
- •Subjects with a drug or food allergy or a history thereof.
- •Subjects with a significant allergic disposition (e.g. asthma requiring treatment) or a history thereof.
- •Subjects with a history of heparin-induced thrombocytopenia.
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Single evaluation of H3 receptor occupancy
Subjects received single-dose of 0.1, 0.2, 0.4, 1, 2.5, 25 mg TS-091 prior to an evaluation of H3 recepto occupancy
干预措施: TS-091 (Drug)
Multiple evaluations of H3 receptor occupancy
Subjects received single-dose of 5, 12.5, 25 mg TS-091 prior to Multiple evaluations of H3 recepto occupancy
干预措施: TS-091 (Drug)
结局指标
主要结局
H3 receptor occupancy
时间窗: 2 hours after administration of TS-091
H3 receptor occupancy is calcurated at 2 hours after administration of TS-091.
Changes in the H3 receptor occupancy
时间窗: 2, 6, and 26 hours after administration of TS-091
Changes in the H3 receptor occupancy is calcurated at 2, 6, and 26 hours after administration of TS-091
Plasma concentration of unchanged TS-091
时间窗: 2, 6, and 26 hours after administration of TS-091
Plasma concentration of unchanged TS-091 is calcurated at 2, 6, and 26 hours after administration of TS-091
次要结局
未报告次要终点