Status:
COMPLETED
Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Obesity
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00909766
Start Date
August 1 2009
End Date
June 1 2011
Last Update
November 4 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808