NCT01549054已完成1 期
A Single-center, Randomized, Open-label, Two-part Study to Evaluate Bioavailability of Prototype Third-generation Formulations of E5501 Relative to Second-generation Tablet Formulation in Healthy Subjects
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
- Eisai Inc.
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax
研究概览
简要总结
This is a study in healthy subjects. There are two parts to the study. In the first part of the study each subject will receive a single 10mg dose of each of the four formulations of E550. Based on the results from Part 1, an optimal formulation will be selected for further evaluation in Part 2.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult men and women (age ≥ 18 to ≤ 55 years)
- •Body mass index ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at the time of screening and baseline of Treatment Period 1
- •Platelet count between 120 x 109/L and 300 x 109/L at baseline of each Treatment Period 1, 3, and 5
- •Women of child bearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the Treatment Phase of the study.
- •In addition, other standard criteria for healthy subjects will be used.
排除标准
- •Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the PK of study drug
- •Agents associated with thrombotic events (including oral contraceptives) must be discontinued within 30 days of first study drug administration
- •Evidence of organ dysfunction or any clinically significant event or illness in the subject's medical history, e.g., history of splenectomy.
- •History of arterial or venous thrombosis, including partial or complete thrombosis (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism). Known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency, etc.)
- •Hemoglobin less than the lower limit of normal levels.
- •In addition, other standard criteria for healthy subjects will be used.
研究组 & 干预措施
10-mg dose of E5501 2G tablet
Experimental
干预措施: 10-mg dose of E5501 2G tablet (Drug)
10-mg dose of E5501 cyclodextrin oral solution
Experimental
干预措施: 10-mg dose of E5501 cyclodextrin oral solution (Drug)
10-mg dose of E5501-P21% powder
Experimental
干预措施: 10-mg dose of E5501-P21% powder (Drug)
10-mg dose of E5501 lipid-based oral
Experimental
干预措施: 10-mg dose of E5501 lipid-based oral (Drug)
结局指标
主要结局
Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax
时间窗: 133 days
次要结局
- Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food(133 days)
研究者
研究点 (1)
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