NCT01199341已完成1 期
A Phase I, Open Label, Randomised, Parallel Group Study of Repeated Oral Doses of AZD1981 (100 mg Twice Daily and 400 mg Twice Daily) for Two Weeks and Single Doses of Warfarin (25 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Warfarin and the Effect of AZD1981 on Warfarin Pharmacodynamics in Healthy Male Volunteers
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
- AstraZeneca
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC)
研究概览
简要总结
The primary purpose of this study is to determine whether the treatment with AZD1981 affect the exposure of Warfarin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Have a body mass index between 19 and 30 kg/m2 and weight at least 65 kg and no more than 100 kg
- •Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to screening
- •Volunteers must be willing to use barrier methods of contraception during study and 3 months after the end of their participation in the study
排除标准
- •Volunteer that is inferred to have an increased sensitivity to warfarin based on genotype of CYP2C9 and VKORC
- •Any clinically significant disease or disorder
- •Any clinically relevant abnormal findings in physical examination
研究组 & 干预措施
Treatment A
Experimental
AZD1981, low dose, + Warfarin
干预措施: AZD1981 (Drug)
Treatment B
Experimental
AZD1981, high dose, + Warfarin
干预措施: AZD1981 (Drug)
Treatment A
Experimental
AZD1981, low dose, + Warfarin
干预措施: Warfarin (Drug)
Treatment B
Experimental
AZD1981, high dose, + Warfarin
干预措施: Warfarin (Drug)
结局指标
主要结局
Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC)
时间窗: PK sampling will be performed regularly from Day 1 to Day 22
次要结局
- Explore possible changes in the anticoagulative activity of Warfarin measured by INR .(Will be performed at screening and at all visits during the study period.)
- Pharmacokinetics for AZD1981 measured by AUCτ, Css,max, tmax,ss and CLss/F(PK sampling will be performed regularly from Day 15 to Day 22.)
- Safety and tolerability of AZD1981(Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of PravastatinDrug InteractionNCT01254461AstraZeneca30
已完成
1 期
A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral ContraceptivesOral ContraceptivesNCT01110525AstraZeneca28
已完成
1 期
To Investigate the Effects of AZD1981 on the QT IntervalAsthmaNCT01265641AstraZeneca44
已完成
2 期
Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic PatientsAsthma PatientsNCT01197794AstraZeneca1,144
已完成
1 期
Single and Multiple Ascending Doses of AZD1981 in JapanHealthyNCT00698282AstraZeneca47