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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00909766
First received: May 22, 2009
Last updated: November 29, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Obesity
Drug: BMS-830216
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose and Parallel Arm Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-830216 (Prodrug of BMS-819881) in Obese Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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 [ Time Frame: Within 2 weeks after study drug administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: to assess the multiple-dose PK of BMS-830216 [ Time Frame: Within 2 weeks of study drug administration ] [ Designated as safety issue: No ]
  • Pharmacodynamics: to assess the pharmacodynamic effect of BMS-830216 on body weight and BMI over 4 weeks of therapy [ Time Frame: Within 2 weeks of study drug administration ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909766

Locations
United States, Louisiana
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
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00909766     History of Changes
Other Study ID Numbers: MB123-002
Study First Received: May 22, 2009
Last Updated: November 29, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014