NCT01214122撤回1 期
A Phase I, Open Label, Fixed Sequence, Single Centre Study in Healthy Volunteers to Investigate the Effects of Repeated Oral Doses AZD9668 on the Pharmacokinetics and Pharmacodynamics of a Single Dose of Warfarin
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 试验地点
- 1
- 主要终点
- Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
研究概览
简要总结
The primary purpose of this study is to determine whether the treatment with AZD9668 will affect the metabolism and effect of Warfarin.
研究设计
- 研究类型
- Interventional
- 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
- •Provision of signed informed consent (including genotyping screening sample for CYP2C9 and VKORC1) prior to any study specific procedures
- •Subjects must be willing to use a barrier method of contraception, unless their partners are post-menopausal or surgically sterile, or if a female partner is of childbearing potential the subject must use a barrier method of contraception (condom) and the partner must use accepted contraceptive methods (oral contraceptive, implant, long term injectable contraceptive or intrauterine device), from first dose of IP (warfarin and AZD9668) until 3 months after last dose of IP (warfarin and AZD9668)
- •Have a body mass index between 19 and 30 kg/m2 (inclusive) and a weight between 50 and 100 kg (inclusive)
- •Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to Visit 1.
排除标准
- •Any clinically significant disease or disorder
- •Subject predicted to have high sensitivity to warfarin based on CYP2C9 and VKORC1 genotypes
- •Any clinically relevant abnormal findings in physical examination
研究组 & 干预措施
Treatment A
Experimental
AZD9668 - 2 x30mg tablets
干预措施: AZD9668 (Drug)
Treatment B
Experimental
Warfarin - 10 x2.5 mg tablets
干预措施: Warfarin (Drug)
结局指标
主要结局
Pharmacokinetics for (R)- and (S)- Warfarin, measured by maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve (AUC)
时间窗: Pharmacokinetic (PK) sampling will be performed day 23
Pharmacodynamics measured by maximum international normalised ratio ( INRmax)
时间窗: International normalised ratio (INR) sampling will be performed day 23
次要结局
- Pharmacokinetics for (R)- and (S)- Warfarin measured Vz/F.(Range from day 1 to 23)
- Pharmacokinetics for (R)- and (S)- Warfarin measured CL/F.(Range from day 1 to 23)
- Pharmacokinetics for AZD9668 measured by Css,max(Range from day 9 to 23)
- Pharmacokinetics for AZD9668 measured by tss,max(Range from day 9 to 23)
- Pharmacokinetics for AZD9668 measured by Css,min(Range from day 9 to 23)
- Pharmacokinetics for AZD9668 measured by CLss/F(Range from day 9 to 23)
- Severity of Adverse Events as a Measure of Safety and Tolerability(Adverse events will be collected pre-dose, during treatment and at follow up)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Adverse events will be collected pre-dose, during treatment and at follow up)
- Pharmacokinetics for (R)- and (S)- Warfarin measured tmax.(Range from day 1 to 23)
- Pharmacokinetics for (R)- and (S)- Warfarin measured t½.(Range from day 1 to 23)
研究者
研究点 (1)
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