Obesity
Conditions
Brief 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.
Interventions
DRUGBMS-830216
Capsules, Oral, 30 mg, once daily, 28 days
DRUGPlacebo
Capsules, Oral, 0 mg, once daily, 28 days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations and clinical laboratory tests | Within 2 weeks after study drug administration |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Pharmacokinetics: to assess the multiple-dose PK of BMS-830216 | Within 2 weeks of study drug administration |
Countries
United States
Outcome results
None listed