NCT01525823已完成1 期
Effects of Metformin on Glucose Homeostasis Following Administration of BMS-754807 in Healthy Volunteer Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2012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
- 26
- 试验地点
- 1
- 主要终点
- Mean difference of the peak plasma glucose concentrations following administration of BMS-754807 alone and following 2 weeks of Metformin administration
研究概览
简要总结
The purpose of this study is to assess the effects of Metformin administered over two weeks on the peak plasma glucose concentrations following administration of BMS-754807.
详细描述
Primary Purpose: Other - Protocol designed to evaluate pharmacodynamics following administration of two compounds
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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 subjects ages 18 to 55 determined with no clinically significant deviation from normal medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory
- •Women who are not of childbearing potential
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 consistent with a healthy volunteer target population
- •History of clinically relevant hypoglycemic events
- •History of clinically relevant hyperglycemic events
研究组 & 干预措施
BMS-754807 + Metformin
Experimental
干预措施: BMS-754807 (IGR-IR/IR Inhibitor) (Drug)
BMS-754807 + Metformin
Experimental
干预措施: Metformin (Drug)
结局指标
主要结局
Mean difference of the peak plasma glucose concentrations following administration of BMS-754807 alone and following 2 weeks of Metformin administration
时间窗: On Day 3 and Day 17
次要结局
- Safety endpoints: AEs and marked clinical laboratory abnormalities(Day -21 to Day 47)
- Maximum observed plasma concentration (Cmax) of BMS-754807 and M5(9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose)
- Time of maximum observed plasma concentration (Tmax) of BMS-754807 and M5(9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose)
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-754807 and M5(12 timepoints over 72 hours for the Day 5 dose)
- Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-754807 and M5(9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose)
- Area under the plasma concentration-time curve from time zero to the last quantifiable plasma concentration [AUC(0-T)] of BMS-754807 and M5(9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose)
- Plasma half-life (T-HALF) of BMS-754807 and M5(12 timepoints over 72 hours for the Day 5 dose)
- Accumulation index; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (AI) of BMS-754807 and M5(9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose)
- Mean levels of plasma glucose, serum insulin and c-peptide(Day 3, Day 5 and Day 17)
研究者
研究点 (1)
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