NL-OMON34620已完成不适用
An Open-label, Single-Sequence Study to Evaluate the Effects of Diltiazem, a Moderate CYP3A4/5 Inhibitor, on the Pharmacokinetics and Pharmacodynamics of E5555 and its Metabolites in Healthy Subjects - E5555/diltiazem DDI study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eisai
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy males or females
- •18-55 years
- •non smoker or have not used nicotine-containing products for at least 3 months prior to first dosing
- •BMI between 18.0 and 32.0 kg/m2
- •no known personal or family medical history of bleeding disorders, or spontaneous gum bleeding by history
排除标准
- •1. A family history, past medical history or clinical signs and symptoms of a bleeding diathesis
- •2. History of any medical condition, which will result in an increased risk of bleeding including but not limited to active or recurrent gastric ulcers, recent head trauma or surgery, severe hypertension, bacterial endocarditis, etc
- •3. Subjects with a history of spontaneous gum bleeding or clinical signs and symptoms on physical exam
- •4. Clinically significant ocular disease or untreated visual or ocular symptoms
- •5. Clinically significant abnormal ECGs prior to dosing (Screening or Baselines) including a QT interval corrected for heart rate using Bazett*s formula (QTcB) > 450 ms for males and > 470 ms for females
- •6. Any history or past medical condition that will result in QTc prolongation or tachyarrhythmia such as Torsades de Pointes (includes hypokalemia, known family history of long QT syndrome, or any other known risk factors for Torsades de Pointes)
- •7. Subjects with renal insufficiency (i.e., a glomerular filtration rate (GFR) <60 mL/min/1.733)
- •8. A platelet count < 150,000 or > 390,000 per mL at Screening or Baseline Period 1
- •9. Abnormal (< 80%) arachidonic acid induced platelet aggregation at Baseline Period 1
- •10. History of unexplained syncope, hepato-biliary disease, sinus bradycardia, heart blocks, sick-sinus syndrome, cardiogenic shock, heart failure, seizures, or chronic obstructive lung disease
- •11. Systolic blood pressure < 100 millimeters of mercury (mmHg) at Screening or Baseline Period 1
- •12. A,PT, aPTT * 1.10 times ULN at Baseline (Period 1)
- •13. Received blood, donated blood, or experienced significant blood loss within 60 days prior to check-in
- •14. Previous history of anaphylactic or anaphylactoid reactions or known hypersensitivity to one or more drugs
- •15. Hypersensitivity to diltiazem or related compounds or ingredients in the formulation
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