A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986209 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Incidence of AEs leading to discontinuation
研究概览
简要总结
The purpose of this study is to investigate the safety and tolerability of BMS-986209 in healthy participants. The first-in-human study is designed in 3 parts that vary based on duration and food effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Parts A,B,(Participant, Care Provider, Investigator) Part C is open-labeled and a cross- over design
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 male and female participants (not of childbearing potential) as determined by no deviation considered significant by the investigator from normal in medical history, physical examination, 12-lead ECG measurements, and clinical laboratory determinations
- •Women and men must agree to follow specific methods of contraception if applicable.
- •Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants
排除标准
- •Women who are of childbearing potential
- •Women who are breastfeeding
- •Any acute or chronic medical illness
- •History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study treatment administration)
- •History of heart disease or conduction disorders
- •Head injury in the last 2 years, intracranial tumor, or aneurysm
- •Known abdominal aneurysm
- •Current or history of rectal bleeding, hematemesis, or hematuria
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part A:SAD
Single Ascending Dose
干预措施: BMS-986209 (Drug)
Part B: MAD
Multiple Ascending Dose
干预措施: BMS-986209 (Drug)
Part C: DDI
Drug-Drug Interaction
干预措施: BMS-986209 (Drug)
Part C: DDI
Drug-Drug Interaction
干预措施: Itraconazole (Drug)
Part C: DDI
Drug-Drug Interaction
干预措施: Diltiazem (Drug)
Part A (SAD) Placebo
干预措施: BMS-986209 Placebo (Other)
Part B (MAD) Placebo
干预措施: BMS-986209 Placebo (Other)
结局指标
主要结局
Incidence of AEs leading to discontinuation
时间窗: Up to 18 days
Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests
时间窗: Up to 16 days
Incidence of clinically significant changes in vital signs: Body temperature
时间窗: Up to 18 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
时间窗: Up to 18 days
Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests
时间窗: Up to 16 days
Incidence of serious AEs (SAEs)
时间窗: Up to 44 days
Incidence of clinically significant changes in vital signs: Respiratory Rate
时间窗: Up to 18 days
Incidence of clinically significant changes in vital signs: Resting pulse rate
时间窗: Up to 18 days
Incidence of Adverse Events (AEs) including bleeding
时间窗: Up to 18 days
Incidence of clinically significant changes in vital signs: Seated blood pressure
时间窗: Up to 18 days
Incidence of clinically significant changes in clinical laboratory tests: Hematology tests
时间窗: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests
时间窗: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serology tests
时间窗: Up to 16 days
次要结局
- Incidence of clinically significant changes in vital signs: Respiratory Rate(Up to 18 days)
- Percent change from baseline in factor XI (FXI) clotting activity(Up to 16 days)
- Incidence of Adverse Events (AEs) including bleeding(Up to 18 days)
- Incidence of clinically significant changes in vital signs: Seated blood pressure(Up to 18 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters(Up to 18 days)
- Maximum observed plasma concentration (Cmax) of BMS-986209(Up to 18 days)
- Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests(Up to 16 days)
- Incidence of serious AEs (SAEs)(Up to 44 days)
- Incidence of AEs leading to discontinuation(Up to 18 days)
- Incidence of clinically significant changes in vital signs: Body temperature(Up to 18 days)
- Incidence of clinically significant changes in vital signs: Resting pulse rate(Up to 18 days)
- Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests(Up to 16 days)
- Incidence of clinically significant changes in clinical laboratory tests: Serology tests(Up to 16 days)
- Percent change from baseline in plasma activated partial thromboplastin time (aPTT) levels(Up to 16 days)
- Time of Maximum observed plasma concentration (Tmax) of BMS-986209(Up to 18 days)
- Terminal plasma half-life (T-Half) of BMS-986209(Up to 18 days)
- Incidence of clinically significant changes in clinical laboratory tests: Hematology tests(Up to 16 days)
- Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests(Up to 16 days)