NCT01105429已完成1 期
Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-820132 in Subjects With Type 2 Diabetes on Background Therapy of Metformin
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2010年5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
- 56
- 试验地点
- 3
- 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
BMS-820132 is an investigational new drug being developed by BMS for treating Type 2 diabetes. The purpose of this study is to test the safety/tolerability (potential side effects) of single doses of the investigational new drug, as well as the amount of study drug in the blood, in subjects with type 2 diabetes.
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
- 否
入选标准
- •Males and females of childbearing potential (willing to use an acceptable method of contraception), or females of non-childbearing potential (i.e., post-menopausal or surgically sterile)
- •Diagnosis of type 2 diabetes treated with metformin monotherapy on a stable regimen for at least 2 months
- •Body Mass Index (BMI) of 18 to 40 kg/m2
- •Fasting glucose in the range of 100-250 mg/dL
- •Hemoglobin A1c (HbA1c) in the range of 6.5% -9.5%
排除标准
- •Clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- •Any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, or depression
- •Past history of diabetic ketoacidosis and/or C-peptide < 1.0 ng/mL, hyperosmolar nonketotic syndrome, lactic acidosis, or recurrent hypoglycemia
- •Any major surgery within 4 weeks of study drug administration
- •Any gastrointestinal surgery that could impact upon the absorption of study drug
- •Smoking more than 10 cigarettes per day
- •Recent drug or alcohol abuse
- •Women who are pregnant or breastfeeding
- •Positive urine screen for drugs of abuse
- •Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
研究组 & 干预措施
BMS-820132 (30 mg) or Placebo
Active Comparator
干预措施: Placebo (Drug)
BMS-820132 (0.3 mg) or Placebo
Active Comparator
干预措施: BMS-820132 (Drug)
BMS-820132 (0.3 mg) or Placebo
Active Comparator
干预措施: Placebo (Drug)
BMS-820132 (1.0 mg) or Placebo
Active Comparator
干预措施: BMS-820132 (Drug)
BMS-820132 (1.0 mg) or Placebo
Active Comparator
干预措施: Placebo (Drug)
BMS-820132 (3 mg) or Placebo
Active Comparator
干预措施: BMS-820132 (Drug)
BMS-820132 (3 mg) or Placebo
Active Comparator
干预措施: Placebo (Drug)
BMS-820132 (10 mg) or Placebo
Active Comparator
干预措施: BMS-820132 (Drug)
BMS-820132 (10 mg) or Placebo
Active Comparator
干预措施: Placebo (Drug)
BMS-820132 (30 mg) or Placebo
Active Comparator
干预措施: BMS-820132 (Drug)
BMS-820132 (75 mg) or Placebo
Active Comparator
干预措施: BMS-820132 (Drug)
BMS-820132 (75 mg) or Placebo
Active Comparator
干预措施: Placebo (Drug)
BMS-820132 (150 mg) or Placebo
Active Comparator
干预措施: BMS-820132 (Drug)
BMS-820132 (150 mg) or Placebo
Active Comparator
干预措施: Placebo (Drug)
BMS-820132 (300 mg) or Placebo
Active Comparator
干预措施: BMS-820132 (Drug)
BMS-820132 (300 mg) or Placebo
Active Comparator
干预措施: Placebo (Drug)
BMS-820132 (TBD) or Placebo
Active Comparator
干预措施: BMS-820132 (Drug)
BMS-820132 (TBD) or Placebo
Active Comparator
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 5 days of study drug administration
次要结局
- Exposure to the investigational drug and its metabolites(Within 2 days after study drug administration)
- Pharmacodynamic activity of the investigational drug on biomarkers(Within 2 days after study drug administration)
- Excretion of the investigational drug and metabolites from the body(Within 2 days after study drug administration)
研究者
研究点 (3)
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