A Study to Investigate the Effect of MT-8554 on the Pharmacokinetics of Simvastatin and Rosuvastatin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve (AUC) of rosuvastatin alone and in the presence of MT-8554.
研究概览
简要总结
The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of simvastatin and rosuvastatin 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy and free from clinically significant illness or disease
- •Male Caucasian subjects aged 18 to 55
- •A body weight of ≥60 kg
排除标准
- •Participation in more than three clinical studies involving administration of an Investigational Medicinal Product in the previous year, or any study within 12 weeks.
- •Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder.
- •Clinically relevant abnormal medical history, physical findings or laboratory values
研究组 & 干预措施
MT-8554, rosuvastatin and simvastatin
Subjects will be administered a single dose of rosuvastatin followed on Day 4 by a single dose of simvastatin. MT-8554 will be administered from Days 6 to 12 with co-administration of rosuvastatin and simvastatin on Days 9 and 12, respectively.
干预措施: MT-8554 (Drug)
MT-8554, rosuvastatin and simvastatin
Subjects will be administered a single dose of rosuvastatin followed on Day 4 by a single dose of simvastatin. MT-8554 will be administered from Days 6 to 12 with co-administration of rosuvastatin and simvastatin on Days 9 and 12, respectively.
干预措施: rosuvastatin (Drug)
MT-8554, rosuvastatin and simvastatin
Subjects will be administered a single dose of rosuvastatin followed on Day 4 by a single dose of simvastatin. MT-8554 will be administered from Days 6 to 12 with co-administration of rosuvastatin and simvastatin on Days 9 and 12, respectively.
干预措施: simvastatin (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve (AUC) of rosuvastatin alone and in the presence of MT-8554.
时间窗: 72 hours post dose
Cmax of rosuvastatin alone and in the presence of MT-8554.
时间窗: 72 hours post dose
AUC of simvastatin/simvastatin acid alone and in the presence of MT-8554.
时间窗: 24 hours post dose
Cmax of simvastatin/simvastatin acid alone and in the presence of MT-8554.
时间窗: 24 hours post dose
次要结局
- Safety and Tolerability as measured by vital signs(Up to Day 16)
- Safety and Tolerability as measured by number of participants with adverse events(Up to Day 16)