Phase 1, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses Of ISIS 681257 40 mg Subcutaneous Injections On The Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.
研究概览
简要总结
This is a single center, open label, single sequence, two-treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of a single dose of warfarin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Motivated and available for duration of study and willing to adhere to protocol
- •Males who are unable to procreate or agree to contraception throughout study
- •Females who are postmenopausal or surgically sterile
- •BMI between 18.5 and 30 kg/m2
- •Weighing greater than or equal to 50kg
- •Normal lab results
- •No known diseases or significant findings on physical exam
排除标准
- •Females of childbearing potential
- •Reactions/infection at injection site
- •Hypersensitivity to any drugs or similar drugs to those used in the study
- •Conditions or disease that may interfere with study drug
- •Any significant diseases
- •Known history or familial history of bleeding disorders
- •Drug dependency or abuse
- •Illness within 28 days
- •Previous exposure to other investigational drug within 28 days
- •Blood donations within 28 days
研究组 & 干预措施
Single dose of warfarin
Single dose of warfarin administered to obtain pharmacokinetic information.
干预措施: Warfarin (Drug)
Warfarin in combination with ISIS 681257
ISIS 681257 administered and pharmacokinetic assessments are taken. Then ISIS 681257 is administered with warfarin and additional pharmacokinetic information is obtained.
干预措施: ISIS 681257 (Drug)
Warfarin in combination with ISIS 681257
ISIS 681257 administered and pharmacokinetic assessments are taken. Then ISIS 681257 is administered with warfarin and additional pharmacokinetic information is obtained.
干预措施: Warfarin (Drug)
结局指标
主要结局
The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.
时间窗: Each day for days 1-10 and 15-45
To evaluate the effect of multiple doses of ISIS 681257 40 mg subcutaneous injections on the pharmacokinetics of a single oral dose of warfarin in healthy adult subjects.
次要结局
- The safety of ISIS 681257 by the incidence of treatment-emergent adverse events.(45 days)
- Prothrombin Time will be measured by testing blood samples at each individual time point.(Each day for days 1-7 and 15-21)
- International normalized ratio will be measured at each individual time point by comparing prothrombin time to the normal mean prothrombin time.(Each day for days 1-7 and 15-21)
- Activated partial thromboplastin time will be measured by testing blood samples at each individual time point.(Each day for days 1-7 and 15-21)
- The plasma concentrations of warfarin and ISIS 681257 will be measured at each individual time point.(Each day for days 1-10 and 15-45)