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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: BMS-830216; Drug: Placebo

• Registration Number: NCT00909766
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-05-27
• Study First Posted: 2009-05-28
• Study Start: 2009-08
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Disposition First Submitted: 2015-09-23
• Status Verified: 2015-10
• Disposition First Submitted QC: 2015-10-12
• Last Update Submitted: 2015-10-12
• Disposition First Posted: 2015-11-04
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Panel B	Placebo	-
Panel C	BMS-830216	-
Panel C	Placebo	-
Panel D	BMS-830216	-
Panel E	Placebo	-
Panel A	Placebo	-
Panel A	BMS-830216	-
Panel D	Placebo	-
Panel G	BMS-830216	High Dose
Panel H	Placebo	-
Panel B	BMS-830216	-
Panel E	BMS-830216	-
Panel F	BMS-830216	Low Dose

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States