NCT00909766已完成1 期
Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose and Parallel Arm Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-830216 (Prodrug of BMS-819881) in Obese Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2009年8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
- 113
- 试验地点
- 1
- 主要终点
- Safety: safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations and clinical laboratory tests
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and effect on body weight and other obesity-related factors of different doses of BMS-830216, compared to placebo. The study will also determine the amount of BMS-830216 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obese subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- •Body Mass Index (BMI) of 30 to 40 kg/m², inclusive
- •Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55, inclusive
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 beyond what is consistent with the target population
- •Female of childbearing potential
- •Sexually active fertile male not using effective birth control method (for example, condom) if your partners are females of childbearing potential
- •Abnormal blood work results (for example, triglyceride ≥ 400 mg/dL, glucose ≥126 mg/dL and total cholesterol ≥ 300 mg/dL)
- •High blood pressure (≥160/95 mm Hg)
- •Major surgical procedure within 4 weeks prior to randomization
- •Chronic infections (e.g., HIV [human immunodeficiency virus] or Hepatitis C)
- •Clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease, or a previous surgery for weight loss
- •History of gastrointestinal disease within the past 3 months
- •History of Type I or Type II diabetes in the past 12 months
- •A lifetime history of a suicide attempt or history of any suicidal behavior in the past month
- •Any clinically significant medical condition that could potentially affect your participation in the study and/or personal well-being, as judged by the investigator
- •Used grapefruit or grapefruit juice within 1 week prior to randomization
- •Donated blood or blood products to a blood bank, blood transfusion or participated in a clinical study (except a screening visit) requiring withdrawal of blood within 4 weeks prior to randomization
- •Unable to tolerate oral and/or intravenous (IV) medications
- •Unable to tolerate the puncturing of veins for drawing of blood
- •Prior exposure to BMS-830216
- •History of prior weight loss (for example, gastric bypass or gastric banding) or gastrointestinal surgery that could impact the absorption of study drug
- •History of a Major Depressive Disorder within the past 2 years
- •Known allergy or hypersensitivity to any component of the study medication
- •History of any significant drug allergies (such as anaphylaxis or hepatotoxicity)
- •Used any oral, injectable or implantable hormonal contraceptive agents (for example, birth control pills, Depo-Provera, or NuvaRing) within 3 months prior to randomization
- •Used any prescription drugs or over the counter products to control acid (for example, Prevacid, Mylanta or Rolaids) within 4 weeks prior to randomization
- •Used any prescription drugs, over the counter medications and herbal preparations within 1 week prior to randomization
- •Taken St. John's Wort within 1 week prior to randomization
- •Taken any investigational drug or placebo (inactive drug) within 4 weeks prior to randomization
研究组 & 干预措施
Panel A
Active Comparator
干预措施: BMS-830216 (Drug)
Panel A
Active Comparator
干预措施: Placebo (Drug)
Panel B
Active Comparator
干预措施: BMS-830216 (Drug)
Panel B
Active Comparator
干预措施: Placebo (Drug)
Panel C
Active Comparator
干预措施: BMS-830216 (Drug)
Panel C
Active Comparator
干预措施: Placebo (Drug)
Panel D
Active Comparator
干预措施: BMS-830216 (Drug)
Panel D
Active Comparator
干预措施: Placebo (Drug)
Panel E
Active Comparator
干预措施: BMS-830216 (Drug)
Panel E
Active Comparator
干预措施: Placebo (Drug)
Panel F
Active Comparator
Low Dose
干预措施: BMS-830216 (Drug)
Panel G
Active Comparator
High Dose
干预措施: BMS-830216 (Drug)
Panel H
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations and clinical laboratory tests
时间窗: Within 2 weeks after study drug administration
次要结局
- Pharmacokinetics: to assess the multiple-dose PK of BMS-830216(Within 2 weeks of study drug administration)
- Pharmacodynamics: to assess the pharmacodynamic effect of BMS-830216 on body weight and BMI over 4 weeks of therapy(Within 2 weeks of study drug administration)
研究者
研究点 (1)
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