A Randomized, Cross-over Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986177 (an Oral Antithrombotic) With Single and Dual Antiplatelet Therapy (Aspirin and Clopidogrel) in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
This study will investigate the safety and interaction of BMS-986177 in healthy volunteers, when administered with Aspirin and/or Clopidogrel
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Must have a Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
- •Must have a normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) of > 80 mL/min/1.73 m2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula and the absence of protein in the urine
- •For Parts 1 and 2:
- •Must be a clopidogrel responder (eg, a decrease in platelet aggregation of at least 30% after a single 600-mg dose of clopidogrel compared with baseline).
排除标准
- •Any significant acute or chronic medical illness, including tinnitus or any other condition listed as a contraindication in the aspirin package insert.
- •History of dizziness and/or recurrent headaches (i.e. daily headaches lasting for 1 week's duration in the last month prior to study treatment administration).
- •History of head injury in the last 2 years, including participants with base skull fractures, intracranial tumor, or aneurysm.
- •History of gastroesophageal reflux disease, dyspepsia (indigestion), protracted nausea, or chronic diarrhea (defined as 3 or 4 loose stools per day that last for ≥ 4 weeks) within the past 6 months.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
BMS-986177 + Aspirin + Clopidogrel (Part 1)
BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
干预措施: BMS-986177 (Drug)
BMS-986177 + Aspirin + Clopidogrel (Part 1)
BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
干预措施: Clopidogrel (Drug)
BMS-986177 + Aspirin + Clopidogrel (Part 1)
BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
干预措施: Aspirin (Drug)
BMS-986177 (Part 1)
BMS-986177 200 mg capsule twice daily (days 1-5)
干预措施: BMS-986177 (Drug)
BMS-986177 placebo + Aspirin + Clopidogrel (Part 1)
BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg once daily (day 1) then 75 mg tablet once daily (days 2-5)
干预措施: Placebo (for BMS-986177) (Other)
BMS-986177 placebo + Aspirin + Clopidogrel (Part 1)
BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg once daily (day 1) then 75 mg tablet once daily (days 2-5)
干预措施: Aspirin (Drug)
BMS-986177 placebo + Aspirin + Clopidogrel (Part 1)
BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg once daily (day 1) then 75 mg tablet once daily (days 2-5)
干预措施: Clopidogrel (Drug)
BMS-986177 (Part 2)
BMS-986177 200 mg capsule twice daily (days 1-5)
干预措施: BMS-986177 (Drug)
BMS-986177 placebo + Clopidogrel (Part 2)
BMS-986177 placebo match capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
干预措施: Placebo (for BMS-986177) (Other)
BMS-986177 placebo + Clopidogrel (Part 2)
BMS-986177 placebo match capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
干预措施: Clopidogrel (Drug)
BMS-986177 + Clopidogrel (Part 2)
BMS-986177 200 mg capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
干预措施: BMS-986177 (Drug)
BMS-986177 + Clopidogrel (Part 2)
BMS-986177 200 mg capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
干预措施: Clopidogrel (Drug)
BMS-986177 (Part 3)
BMS-986177 200 mg capsule twice daily (days 1-5)
干预措施: BMS-986177 (Drug)
BMS-986177 placebo + Aspirin (Part 3)
BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)
干预措施: Placebo (for BMS-986177) (Other)
BMS-986177 placebo + Aspirin (Part 3)
BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)
干预措施: Aspirin (Drug)
BMS-986177 + Aspirin (Part 3)
BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)
干预措施: BMS-986177 (Drug)
BMS-986177 + Aspirin (Part 3)
BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)
干预措施: Aspirin (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Up to Day 33
Incidence of Serious Adverse Events (SAEs)
时间窗: Up to Day 95
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
时间窗: Up to Day 33
Incidence of Adverse Events (AEs) leading to discontinuation
时间窗: Up to Day 33
Number of participants with vital sign abnormalities
时间窗: Up to Day 33
Number of participants with physical examination abnormalities
时间窗: Up to Day 33
Number of participants with clinical laboratory abnormalities
时间窗: Up to Day 33
次要结局
- Maximum observed plasma concentration (Cmax)(Up to Day 33)
- Area under the plasma concentration time curve in one dosing interval [AUC(TAU)](Up to Day 33)
- Time of maximum observed concentration (Tmax)(Up to Day 33)
- Terminal plasma half-life (T-HALF)(Up to Day 33)
- Trough observed plasma concentration (Ctrough)(Up to Day 26)
- Apparent total body clearance (CLT/F)(Up to Day 33)
- Volume of distribution (Vz/F)(Up to Day 33)