NCT00099450已完成1 期
Single-Center, Open-Labeled Dose Escalation Followed by Randomized, Double-Blind, Placebo-Controlled Cohort Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Platelet function
研究概览
简要总结
The objectives of this study are to look at the safety and tolerability of the experimental drug, how people process the drug, how the drug affects people, and to identify a dose or doses to study in subsequent future studies.
详细描述
The purposes of this trial are to determine if administration of INS50589 Intravenous Infusion is well tolerated, to determine the pharmacological effects of INS50589 at different doses, and to identify an appropriate dose for later efficacy studies. More specifically, the objectives are to:
- Evaluate safety and tolerability
- Evaluate pharmacokinetics of INS50589 and its major metabolite(s)
- Evaluate effects of INS50589 on platelet function at various dose levels
- Evaluate potential relationship between plasma concentrations of INS50589 and various pharmacodynamic endpoints
- Identify one or more dose levels of INS50589 for future studies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
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
- •Have body mass index (BMI) between 18.5 kg/m2 and 35 kg/m2 and body weight no greater than 120 kg.
- •If female, must not be pregnant or lactating, and if of childbearing potential or sexually active, must use acceptable method of birth control.
排除标准
- •Have clinically significant acute or chronic disease (e.g., coronary artery disease, diabetes, chronic renal insufficiency, asthma).
- •Have major surgery within eight weeks of dosing.
- •Have overt viral illness within four weeks of dosing.
- •Have tendency or history in family of tendency for bleeding.
- •Have clinically significant abnormalities on clinical laboratory tests (chemistry, hematology, urinalysis).
- •Have taken aspirin or any other non-steroidal anti-inflammatory drug (NSAID) within 10 days prior to admission to study facility.
- •Have ever taken or received any of the following for medical conditions: (antiplatelet compounds including clopidogrel, ticlopidine, dipyridamole, tirofiban, eptifibatide, abciximab, adenosine, and prostacyclin) or (anticoagulants including vitamin K antagonists, thrombin inhibitors, heparins, hirudin or related compounds, argatroban and factor Xa inhibitors)
- •Have a clinically significant ECG abnormality.
结局指标
主要结局
Platelet function
次要结局
- Pilot study - not specified
研究者
研究点 (2)
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