A Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban in Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- [Part 1] Change in P2Y12 Reaction Unit (PRU) from baseline on day 8
研究概览
简要总结
to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None (open label)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject aged ≥ 19 years to < 65 years at the time of screening
- •Subjects who weigh ≥ 50 kg (or ≥ 45 kg in the case of females) with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
- •Subjects who have voluntarily decided to participate after fully understanding the clinical trial based on the detailed explanation given, and have provided written informed consent before the screening procedure.
排除标准
- •Subject who has a clinically significant history of disease in the liver, kidneys, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hematopoietic and oncological system, or cardiovascular system.
- •The Subject who has a clinically significant bleeding or a history of congenital or acquired bleeding disorders such as hemophilia
- •Subject who has a history of gastrointestinal disorders (e.g., Crohn's disease, ulcerative disease, etc.) or surgery (excluding appendectomy, hernia repair, endoscopic polypectomy, or hemorrhoidectomy, fissure, or fistula surgery) that may affect the absorption of the investigational product.
- •The subject who has a hereditary disorder (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption etc.).
- •Screening laboratory test showing any of the following abnormal laboratory results
- •Subjects who are judged unsuitable to participate in the study in the opinion of the investigator
研究组 & 干预措施
Part 1
JP-1366 and clopidogrel
干预措施: JP-1366 and clopidogrel (Drug)
Part 2
JP-1366 and aspirin
干预措施: JP-1366 and aspirin (Drug)
Part 3
JP-1366 and atorvastatin
干预措施: JP-1366 and atorvastatin (Drug)
Part 4
JP-1366 and apixaban
干预措施: JP-1366 and apixaban (Drug)
结局指标
主要结局
[Part 1] Change in P2Y12 Reaction Unit (PRU) from baseline on day 8
时间窗: baseline on day 8
Change in P2Y12 Reaction Unit (PRU)
[Part 2] Emax of arachidonic acid-induced platelet aggregation
时间窗: up to 48 hours post-dose on Day 1
Emax of arachidonic acid-induced platelet aggregation
[Part 2] AUEC0-24 of arachidonic acid-induced platelet aggregation
时间窗: up to 48 hours post-dose on Day 1
AUEC0-24 of arachidonic acid-induced platelet aggregation
[Part 2] AUClast of Aspirin
时间窗: up to 48 hours post-dose on Day 1
AUClast of Aspirin
[Part 3] AUCτ,ss of JP-1366
时间窗: up to 24 hours post-dose on Day 5
AUCτ,ss of JP-1366
[Part 3] Cmax,ss of Atorvastatin
时间窗: up to 24 hours post-dose on Day 5
Cmax,ss of Atorvastatin
[Part 3] AUCτ,ss of Atorvastatin
时间窗: up to 24 hours post-dose on Day 5
AUCτ,ss of Atorvastatin
[Part 2] Cmax,ss of JP-1366
时间窗: up to 24 hours post-dose on Day 5
Cmax,ss of JP-1366
[Part 2] AUCτ,ss of JP-1366
时间窗: up to 24 hours post-dose on Day 5
AUCτ,ss of JP-1366
[Part 2] Cmax of Aspirin
时间窗: up to 48 hours post-dose on Day 1
Cmax of Aspirin
[Part 4] Cmax,ss of JP-1366
时间窗: up to 24 hours post-dose on Day 5
Cmax,ss of JP-1366
[Part 3] Cmax,ss of JP-1366
时间窗: up to 24 hours post-dose on Day 5
Cmax,ss of JP-1366
[Part 4] Cmax,ss of Apixaban
时间窗: up to 12 hours post-dose on Day 5
Cmax,ss of Apixaban
[Part 4] Emax of Anti-Factor Xa activity
时间窗: up to 48 hours post-dose on Day 5
Emax of Anti-Factor Xa activity
[Part 4] AUEC0-12 of Anti-Factor Xa activity
时间窗: up to 48 hours post-dose on Day 5
AUEC0-12 of Anti-Factor Xa activity
[Part 4] AUCτ,ss of Apixaban
时间窗: up to 12 hours post-dose on Day 5
AUCτ,ss of Apixaban
[Part 4] AUCτ,ss of JP-1366
时间窗: up to 24 hours post-dose on Day 5
AUCτ,ss of JP-1366
次要结局
未报告次要终点