safety, pharmacokinetics and pharmacodynamics study to evaluate bms-830216 in obese subjects

Conditions: Obesity

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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