NCT00836602已完成1 期
Placebo-Controlled, Ascending, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Safety assessment, including medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of BMS-779788 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
- Basic Science
- 盲法
- Triple (Participant, Care Provider, 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
- •Men and women (not of child bearing potential) ages 18 to 45
- •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
- •Women of child bearing potential
- •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
BMS-779788 or Placebo (Arm 1)
Active Comparator
干预措施: Placebo (Drug)
BMS-779788 or Placebo (Arm 2)
Active Comparator
干预措施: BMS-779788 (Drug)
BMS-779788 or Placebo (Arm 2)
Active Comparator
干预措施: Placebo (Drug)
BMS-779788 or Placebo (Arm 1)
Active Comparator
干预措施: BMS-779788 (Drug)
BMS-779788 or Placebo (Arm 3)
Active Comparator
干预措施: BMS-779788 (Drug)
BMS-779788 or Placebo (Arm 3)
Active Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety assessment, including medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
时间窗: 8 times within 27 days of the first dose
次要结局
- Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers)(After each dose panel)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in HealthyHealthy SubjectsOsteoarthritisNCT00380900Wyeth is now a wholly owned subsidiary of Pfizer
已完成
1 期
A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese DescentHealthy ParticipantsNCT05546151Bristol-Myers Squibb24
已完成
1 期
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus ParticipantsLupus Erythematosus, SystemicNCT05278663Eisai Co., Ltd.26
终止
1 期
Phase I, Double-Blind,Placebo, MAD Study to Evaluate the Safety, Tolerability, PK, and PD of AMG 333 in Healthy Subjects and Migraine SubjectsMigraineNCT02132429Amgen16
已完成
1 期
GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy SubjectsHealthyNCT00989703Galapagos NV24