A Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-903452 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and effect on blood glucose control of BMS-903452 compared to placebo in healthy subjects & relative bioavailability of the crystalline and amorphous forms of BMS-903452 [Panels 4,6,11 & 12(Part A)] ; and subjects with type 2 Diabetes Mellitus (Part B). The study will also determine the amount of BMS-903452 in the blood.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically healthy or Clinical diagnosis of Type 2 diabetes on a stable dose of metformin monotherapy
排除标准
- •Type 1 Diabetes
- •History of significant heart disease
- •Prior bariatric surgery
- •Women of childbearing potential
研究组 & 干预措施
BMS-903452 (30 mg) or Placebo - A5
(Healthy Subjects)
干预措施: BMS-903452 (Drug)
BMS-903452 (0.1 mg) or Placebo - A1
(Healthy Subjects)
干预措施: BMS-903452 (Drug)
BMS-903452 (0.1 mg) or Placebo - A1
(Healthy Subjects)
干预措施: Placebo (Drug)
BMS-903452 (0.6 mg) or Placebo - A2
(Healthy Subjects)
干预措施: BMS-903452 (Drug)
BMS-903452 (0.6 mg) or Placebo - A2
(Healthy Subjects)
干预措施: Placebo (Drug)
BMS-903452 (3.0 mg) or Placebo - A3
(Healthy Subjects)
干预措施: BMS-903452 (Drug)
BMS-903452 (3.0 mg) or Placebo - A3
(Healthy Subjects)
干预措施: Placebo (Drug)
BMS-903452 (10 mg) or Placebo - A4
(Healthy Subjects)
干预措施: BMS-903452 (Drug)
BMS-903452 (10 mg) or Placebo - A4
(Healthy Subjects)
干预措施: Placebo (Drug)
BMS-903452 (30 mg) or Placebo - A5
(Healthy Subjects)
干预措施: Placebo (Drug)
BMS-903452 (60 mg) or Placebo - A6
(Healthy Subjects)
干预措施: BMS-903452 (Drug)
BMS-903452 (60 mg) or Placebo - A6
(Healthy Subjects)
干预措施: Placebo (Drug)
BMS-903452 (120 mg) or Placebo - A7
(Healthy Subjects)
干预措施: BMS-903452 (Drug)
BMS-903452 (120 mg) or Placebo - A7
(Healthy Subjects)
干预措施: Placebo (Drug)
BMS-903452 (0.6 mg) or Placebo - B1
(Subjects with type 2 Diabetes Mellitus)
干预措施: Placebo (Drug)
BMS-903452 (0.6 mg) or Placebo - B1
(Subjects with type 2 Diabetes Mellitus)
干预措施: BMS-903452 (Drug)
BMS-903452 (10 mg) or Placebo - B2
(Subjects with type 2 Diabetes Mellitus)
干预措施: Placebo (Drug)
BMS-903452 (10 mg) or Placebo - B2
(Subjects with type 2 Diabetes Mellitus)
干预措施: BMS-903452 (Drug)
BMS-903452 (120 mg) or Placebo - B3
(Subjects with type 2 Diabetes Mellitus)
干预措施: Placebo (Drug)
BMS-903452 (120 mg) or Placebo - B3
(Subjects with type 2 Diabetes Mellitus)
干预措施: BMS-903452 (Drug)
BMS-903452 (10 mg) or Placebo - A11
(Healthy Subjects)
干预措施: BMS-903452 (Drug)
BMS-903452 (10 mg) or Placebo - A11
(Healthy Subjects)
干预措施: Placebo (Drug)
BMS-903452 (60 mg) or Placebo - A12
(Healthy Subjects)
干预措施: BMS-903452 (Drug)
BMS-903452 (60 mg) or Placebo - A12
(Healthy Subjects)
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
时间窗: Within 10 days of study drug administration
次要结局
- Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism(Within 2 days of study drug administration)
- Effect on electrocardiographic (ECG) parameters(Within 10 days of study drug administration)
- Percent urinary recovery (% UR)(Within 10 days of study drug administration)
- Renal clearance (CLR) from plasma(Within 10 days of study drug administration)
- The single-dose pharmacokinetics parameter maximum observed concentration in plasma (Cmax) of BMS-903452 will be derived from the plasma concentration versus time data(Within 10 days after study drug administration)
- The single-dose pharmacokinetics parameter time to reach maximum observed concentration in plasma (Tmax) of BMS-903452 will be derived from the plasma concentration versus time data(Within 10 days after study drug administration)
- The single-dose pharmacokinetics parameter time Area under the plasma concentration-time curve from time zero extrapolated to infinity AUC(INF) of BMS-903452 will be derived from the plasma concentration versus time data(Within 10 days after study drug administration)
- The single-dose pharmacokinetics parameter Area under the plasma concentration-time curve from time zero to last measurable sampling time AUC (0-T) of BMS-903452 will be derived from the plasma concentration versus time data(Within 10 days after study drug administration)
- The single-dose pharmacokinetics parameter Terminal-phase elimination half-life in plasma (T-Half) of BMS-903452 will be derived from the plasma concentration versus time data(Within 10 days after study drug administration)
- The single-dose pharmacokinetics parameter apparent clearance from plasma after extra-vascular administration (CLT/F) of BMS-903452 will be derived from the plasma concentration versus time data(Within 10 days after study drug administration)