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

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