Single and Multiple Dose Pharmacokinetics and Pharmacodynamics of Prasugrel (LY640315) in Korean Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose
研究概览
简要总结
The purpose of this study is to investigate how the body processes prasugrel and how prasugrel affects blood clotting in healthy Korean men. Three different dosing regimens of prasugrel will be given. Information on side effects will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy males, as determined by medical history and physical examination.
- •Are between the ages of 20 and 45 years, inclusive.
- •Have a body mass index (BMI) of 19 kg/m^2 to 27 kg/m^2, inclusive, at screening.
排除标准
- •Are currently enrolled in, or discontinued within the last 60 days from a clinical trial involving an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Have known allergies to prasugrel or related compounds.
- •Are persons who have previously completed or withdrawn from this study or any other study investigating prasugrel.
- •Self-reported history of significant bleeding from trauma (for example, prolonged bleeding after tooth extraction).
- •History of major surgery within 3 months of screening or planned surgery within 14 days after the last day of dosing.
- •Have a platelet count of <100,000/(cubic millimeters) mm^3 at the time of screening.
- •Have tested positive for fecal occult blood at screening.
- •Have significant prolongation of prothrombin time (PT) or activated partial thromboplastin time (APTT) at screening.
- •Have a clinically significant abnormality following the investigator's review of the physical examination, electrocardiogram (ECG)and clinical (safety) laboratory tests at screening.
- •Personal or first-degree family history of coagulation or bleeding disorders (that is, hematemesis, melena, severe or recurrent epistaxis, hemoptysis, gastrointestinal ulcers, hemorrhage, clinically overt hematuria or intracranial hemorrhage) or reasonable suspicion of vascular malformations, for example, cerebral hemorrhage, aneurysm or premature stroke (cerebrovascular accident [CVA] <65 years of age).
- •Have significant active hematological disease and/or whole blood donation of more than 400 mL within the last 2 months and component blood donation within the last month.
- •Volunteers who have an average weekly alcohol intake that exceeds 21 units per week or volunteers unwilling to adhere to study alcohol restrictions during the study (1 unit = 360 mL of beer; 150 mL of wine; 45 mL of distilled spirits).
研究组 & 干预措施
Prasugrel - 60 mg/10 mg
Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
干预措施: Prasugrel (Drug)
Prasugrel - 30 mg/7.5 mg
Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
干预措施: Prasugrel (Drug)
Prasugrel - 30 mg/5 mg
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
干预措施: Prasugrel (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose
时间窗: Day 1 predose up to 24 hours post dose
AUC from time zero to the last quantifiable plasma concentration (tlast)
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose
时间窗: Day 1 predose up to 24 hours post dose
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose
时间窗: Day 1 predose up to 24 hours post dose
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
时间窗: Day 11 predose to 24 hours post dose
AUC from time zero to the last quantifiable plasma concentration (tlast)
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose
时间窗: Day 11 predose to 24 hours post dose
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
时间窗: Day 11 predose to 24 hours post dose
次要结局
- Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation(Predose up to 24 hours post dose on Day 12)
- Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)(Predose up to 24 hours post dose on Day 12)