Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects
Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects
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.
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