A Phase I, Open Label Study to Assess the Effects of TA-8995 on the Pharmacokinetics of Midazolam and Digoxin in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Xention Ltd
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Plasma concentrations of TA-8995, midazolam and digoxin
研究概览
简要总结
A study in healthy males to look at how multiple doses of TA-8995 affect blood levels and rate of removal of other drugs, using single doses of digoxin and midazolam as examples, to see if there are any potential drug interactions that might affect patients in future studies. The study will examine whether co-administration of TA-8995 affects the pharmacokinetics of digoxin and midazolam measured by area under the curve (AUC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Digoxin with/without TA-8995
Digoxin with/without TA-8995
干预措施: TA-8995 (Drug)
Digoxin with/without TA-8995
Digoxin with/without TA-8995
干预措施: Digoxin (Drug)
Midazolam with/without TA-8995
Midazolam with/without TA-8995
干预措施: TA-8995 (Drug)
Midazolam with/without TA-8995
Midazolam with/without TA-8995
干预措施: Midazolam (Drug)
结局指标
主要结局
Plasma concentrations of TA-8995, midazolam and digoxin
时间窗: Over 16 days
次要结局
未报告次要终点
