Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses Of ISIS 681257 40 mg Subcutaneous Injections On The Pharmacokinetics And Pharmacodynamics Of Clopidogrel 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
- Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the PK of multiple oral doses of clopidogrel in healthy adult subjects
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 multiple doses of clopidogrel
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
- 18 Years 至 60 Years（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
Clopidogrel Dosing
Multiple doses of Clopidogrel to obtain pharmacokinetic information.
干预措施: Clopidogrel (Drug)
Clopidogrel in combination with ISIS 681257
Multiple doses of clopidogrel administered with 2 doses of ISIS 681257 at 2 individual timepoints to obtain pharmacokinetic information.
干预措施: ISIS 681257 (Drug)
Clopidogrel in combination with ISIS 681257
Multiple doses of clopidogrel administered with 2 doses of ISIS 681257 at 2 individual timepoints to obtain pharmacokinetic information.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the PK of multiple oral doses of clopidogrel in healthy adult subjects
时间窗: 55 days
The plasma concentrations of Clopidogrel and ISIS 681257 will be measured at each individual time point.
次要结局
- Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (antiplatelet activity) of multiple doses of clopidogrel in healthy adult subjects(55 days)
- Evaluate the safety of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections when co-administered with multiple oral doses of clopidogrel in healthy adult subjects(55 days)