Drug-drug Interaction Study with TS-142 in Healthy Adult Subjects (concomitant Administration of Itraconazole)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This is an open-label, single-center, single-sequence study to evaluate the concomitant effects of the potent CYP3A inhibitor itraconazole on the single-dose pharmakokinetics, safety and tolerability of oral TS-142 in healthy 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 male age 20 to 39 years at the signing of informed consent
- •Subjects whose body mass index (BMI) within the range 18.5 - 25.0 kg/m2, exclusive of 25.0
- •Subjects who judged by the principal investigator(s) or subinvestigator(s) to be appropriate as a subjects of this study based on the results of screening tests and the tests obtained prior to the administration of the investigational drug. (Those who have no abnormal findings in the physical examination, vital signs, and standard 12-lead ECG in the screening test 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. However, if who showed abnormal findings 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 any disease and are judged not to be healthy based on the medical viewpoints by the principal investigator(s) or subinvestigator(s)
- •Subjects who have an inappropriate history for participation in this study, including hepatic, renal, cardiovascular, hematological, endocrinological, metabolic, respiratory, gastrointestinal, dermatological, neurological, urological, immunological, psychiatric abnormalities or diseases
- •Subjects who have any history of drug or food allergies
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Subjects receiving TS-142 and itraconazole
Eligible subjects will receive a single dose of 5 mg TS-142 on Day 1. Subjects will also receive twice-a-day of 200 mg itraconazole on Day 3 and an once-daily single dose of 200 mg itraconazole from Day 4 to Day 7 and single dose of 1 mg TS-142 on Day 6.
干预措施: TS-142 (Drug)
Subjects receiving TS-142 and itraconazole
Eligible subjects will receive a single dose of 5 mg TS-142 on Day 1. Subjects will also receive twice-a-day of 200 mg itraconazole on Day 3 and an once-daily single dose of 200 mg itraconazole from Day 4 to Day 7 and single dose of 1 mg TS-142 on Day 6.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Cmax
时间窗: Sampling at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 48 hours post-dose of TS-142 on Day 1 or Day 6, in addition, at 96, 144, 192, 240 hours post-dose of TS-142 on Day 6.
Maximum observed concentration of unchanged form of TS-142 and its metabolite in plasma.
次要结局
- AUC(0-last)(Sampling at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 48 hours post-dose of TS-142 on Day 1 or Day 6, in addition, at 96, 144, 192, 240 hours post-dose of TS-142 on Day 6.)