A Phase 1 Mass Balance Study of TS-172 in Healthy Adult Subjects

Taisho Pharmaceutical Co., Ltd.1 个研究点分布在 1 个国家目标入组 6 人开始时间: 2024年9月26日最近更新: 2025年2月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Taisho Pharmaceutical Co., Ltd.
入组人数: 6
试验地点: 1
主要终点: Radioactivity concentration in whole blood and plasma

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of TS-172 after single oral dose of [14C] TS-172 in Japanese healthy male subjects.

To assess the safety of single oral dose of [14C] TS-172 in Japanese healthy male subjects.

研究设计

研究类型: Interventional
分配方式: Na
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

•Japanese males aged >=20 and <40 years at the signing of informed consent
•Subjects whose body mass index (BMI) >=18.5 and <25.0 kg/m2 at screening
•Subjects who have no abnormal findings in the physical examination, vital signs, and standard 12-lead ECG in the screening test and the test on the day of admission and the test obtained prior to administration of the investigational drug, and whose clinical test results are within the standard values of the clinical trial site in the screening test and the test on the day of admission. However, if who showed abnormal findings or values outside the reference ranges but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator(s) or subinvestigator(s).
•Subjects who understand, and have willingness and ability to read and sign, the informed consent form

排除标准

•Subjects who have been administered substances labelled with radioisotopes or exposed to high levels of radiation (e.g. CT scan, gastric X-ray, PET scan) within one year prior to dosing of the investigational drug.
•Occupationally exposed worker within one year prior to dosing of the investigational drug (e.g. workers who handle nuclear power or radioactive substances)
•Subjects who have had 3 days or less that one or more spontaneous defecations (defecation that occurs without laxatives, enemas, disimpaction) within 7 days before consent is obtained or during the 7 days until on the day of admission. Those who have diarrhea during the 7 days until on the day of admission
•History of any disease or surgery which have impact on investigational drug absorption such as gastrointestinal ulcer, gastrectomy, gastroenterostomy or bowel resection

研究组 & 干预措施

[14C] TS-172

Experimental

Participants will receive oral [14C] TS-172 under fasted conditions

干预措施: [14C] TS-172 (Drug)