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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014