NCT00707499已完成1 期
A Single-Dose, Phase I, Dosimetry, Biodistribution, and Safety Trial of BMS 747158 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Dosimetry analysis following whole body imaging after resting injection
研究概览
简要总结
The purpose of this clinical research study is to learn the safety and biodistribution of BMS747158 in normal, healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-40
- •BMI 18-30 kg/m2
- •No active or chronic illnesses
- •If female: not pregnant, use of birth control or not of child-bearing potential
排除标准
- •Significant active or chronic illness
- •Any neurological disorder
- •GI disease within 3 months
- •Recent infection
- •Major surgery within 4 weeks
- •Donation of blood within 4 weeks
- •Blood transfusion within 4 weeks
- •Recent history drug/alcohol abuse
- •Head trauma
- •Significant screening ECG, EEG, lab tests, physical exam and vital signs abnormalities
- •Prescription or OTC drugs within 2 weeks
- •Exposure to any other investigational drug/device within 6
研究组 & 干预措施
1
Experimental
干预措施: BMS747158 (Drug)
结局指标
主要结局
Dosimetry analysis following whole body imaging after resting injection
时间窗: Imaging takes place 0 - 310 minutes post injection
次要结局
- Safety analysis following vital signs, ECGs, EEG, neuro and physical exams, telephone and visit follow up, and blood draws for chemistry and hematology post injection of BMS747158 at rest(Screening (14 days prior to dosing) through 14 days post dose administration)
研究者
研究点 (1)
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