跳至主要内容
临床试验/NCT02124954
NCT02124954已完成1 期

A Phase I, Open Label Study to Assess the Effects of TA-8995 on the Pharmacokinetics of Midazolam and Digoxin in Healthy Male Subjects

Xention Ltd1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Digoxin with/without TA-8995

干预措施: TA-8995 (Drug)

Digoxin with/without TA-8995

Experimental

Digoxin with/without TA-8995

干预措施: Digoxin (Drug)

Midazolam with/without TA-8995

Experimental

Midazolam with/without TA-8995

干预措施: TA-8995 (Drug)

Midazolam with/without TA-8995

Experimental

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

研究者

发起方
Xention Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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