Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Panel A
|
Drug: BMS-830216
Capsules, Oral, 30 mg, once daily, 28 days
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 28 days
|
| Active Comparator: Panel B
|
Drug: BMS-830216
Capsules, Oral, 100 mg, once daily, 28 days
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 28 days
|
| Active Comparator: Panel C
|
Drug: BMS-830216
Capsules, oral, 300 mg, once daily, 28 days
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 28 days
|
| Active Comparator: Panel D
|
Drug: BMS-830216
Capsules, oral, 600 mg, once daily 28 days
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 28 days
|
| Active Comparator: Panel E
|
Drug: BMS-830216
Capsules, oral, 1200 mg, once daily, 28 days
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 28 days
|
| Active Comparator: Panel F Low Dose |
Drug: BMS-830216
Capsules, Oral, to be determined, once daily, 28 days
|
| Active Comparator: Panel G High Dose |
Drug: BMS-830216
Capsules, Oral, to be determined, once daily, 28 days
|
| Placebo Comparator: Panel H
|
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 28 days
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pennington Biomedical Research Center | Baton Rouge | Louisiana | United States | 70808 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MB123-002