Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-830216 (Pro-Drug of BMS-819881) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results
研究概览
简要总结
The purpose of this study is to evaluate the safety profile, tolerability, and pharmacokinetics of single oral doses from 10 mg up to 1200 mg of BMS-830216 (pro-drug of BMS-819881) in healthy subjects
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
- •Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men between ages of 18 to 45
排除标准
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
研究组 & 干预措施
Arm 5
BMS-830216 (600 mg)
干预措施: BMS-830216 (Drug)
Arm 1
BMS-830216 (10 mg)
干预措施: BMS-830216 (Drug)
Arm 1
BMS-830216 (10 mg)
干预措施: Placebo (Drug)
Arm 2
BMS-830216 (30 mg)
干预措施: BMS-830216 (Drug)
Arm 2
BMS-830216 (30 mg)
干预措施: Placebo (Drug)
Arm 3
BMS-830216 (100 mg)
干预措施: BMS-830216 (Drug)
Arm 3
BMS-830216 (100 mg)
干预措施: Placebo (Drug)
Arm 4
BMS-830216 (300 mg)
干预措施: BMS-830216 (Drug)
Arm 4
BMS-830216 (300 mg)
干预措施: Placebo (Drug)
Arm 5
BMS-830216 (600 mg)
干预措施: Placebo (Drug)
Arm 6
BMS-830216 (1200 mg)
干预措施: BMS-830216 (Drug)
Arm 6
BMS-830216 (1200 mg)
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results
时间窗: Within the 10 days after study drug administration
次要结局
- Pharmacokinetic profile (drug absorption, distribution, metabolism and excretion process) determined by plasma concentration vs. time profile from a series of plasma samples up to 10 days post dose(Within the 10 days after study drug administration)