Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-866949 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Assessment of safety by evaluating incidence of adverse events (AE)
研究概览
简要总结
The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe and tolerable
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Panels 1-6: Healthy Male Subjects
- •Panel 7: Females
- •Ages 21 to 55, inclusive
- •Body Mass Index (BMI) of 18 to 32 kg/m², inclusive
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
排除标准
- •History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP <21 mmHg)
- •History or family history of psychiatric disorder
- •Current treatment with prescription medication
- •Exposure to any investigational drug or placebo within 12 weeks of study drug administration
研究组 & 干预措施
Placebo or BMS-866949 (3 mg)
Panel 1: Healthy Male Subjects
干预措施: Placebo (Drug)
Placebo or BMS-866949 (3 mg)
Panel 1: Healthy Male Subjects
干预措施: BMS-866949 (Drug)
Placebo or BMS-866949 (10 mg)
Panel 2: Healthy Male Subjects
干预措施: Placebo (Drug)
Placebo or BMS-866949 (10 mg)
Panel 2: Healthy Male Subjects
干预措施: BMS-866949 (Drug)
Placebo or BMS-866949 (30 mg)
Panel 3: Healthy Male Subjects
干预措施: Placebo (Drug)
Placebo or BMS-866949 (30 mg)
Panel 3: Healthy Male Subjects
干预措施: BMS-866949 (Drug)
Placebo or BMS-866949 (45 mg)
Panel 4: Healthy Male Subjects
干预措施: Placebo (Drug)
Placebo or BMS-866949 (45 mg)
Panel 4: Healthy Male Subjects
干预措施: BMS-866949 (Drug)
Placebo or BMS-866949 (60 mg)
Panel 5: Healthy Male Subjects
干预措施: Placebo (Drug)
Placebo or BMS-866949 (60 mg)
Panel 5: Healthy Male Subjects
干预措施: BMS-866949 (Drug)
Placebo or BMS-866949 (90 mg)
Panel 6: Healthy Male Subjects
干预措施: Placebo (Drug)
Placebo or BMS-866949 (90 mg)
Panel 6: Healthy Male Subjects
干预措施: BMS-866949 (Drug)
Placebo or BMS-866949 (3 - 60 mg)
Panel 7: Females
干预措施: Placebo (Drug)
Placebo or BMS-866949 (3 - 60 mg)
Panel 7: Females
干预措施: BMS-866949 (Drug)
结局指标
主要结局
Assessment of safety by evaluating incidence of adverse events (AE)
时间窗: Over a period of 28 days (+/- 2 days) of first dose
次要结局
- Assessment of pharmacokinetics by evaluating plasma concentration versus time data(Over a period 28 days (+/- 2 days) of first dose)
- Assessment of pharmacodynamics by evaluating brain transporter occupancy(Over a period 28 days (+/- 2 days) of first dose)