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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: BMS-830216; Drug: BMS-830216; Drug: BMS-830216; Drug: BMS-830216; Drug: BMS-830216; Drug: BMS-830216

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Panel A	Drug: Placebo; Capsules, Oral, 0 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, 30 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, 100 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 300 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 600 mg, once daily 28 days; Drug: BMS-830216; Capsules, oral, 1200 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, to be determined, once daily, 28 days
Active Comparator: Panel B	Drug: Placebo; Capsules, Oral, 0 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, 30 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, 100 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 300 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 600 mg, once daily 28 days; Drug: BMS-830216; Capsules, oral, 1200 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, to be determined, once daily, 28 days
Active Comparator: Panel C	Drug: Placebo; Capsules, Oral, 0 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, 30 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, 100 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 300 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 600 mg, once daily 28 days; Drug: BMS-830216; Capsules, oral, 1200 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, to be determined, once daily, 28 days
Active Comparator: Panel D	Drug: Placebo; Capsules, Oral, 0 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, 30 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, 100 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 300 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 600 mg, once daily 28 days; Drug: BMS-830216; Capsules, oral, 1200 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, to be determined, once daily, 28 days
Active Comparator: Panel E	Drug: Placebo; Capsules, Oral, 0 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, 30 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, 100 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 300 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 600 mg, once daily 28 days; Drug: BMS-830216; Capsules, oral, 1200 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, to be determined, once daily, 28 days
Active Comparator: Panel F; Low Dose	Drug: BMS-830216; Capsules, Oral, 30 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, 100 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 300 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 600 mg, once daily 28 days; Drug: BMS-830216; Capsules, oral, 1200 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, to be determined, once daily, 28 days
Active Comparator: Panel G; High Dose	Drug: BMS-830216; Capsules, Oral, 30 mg, once daily, 28 days; Drug: BMS-830216; Capsules, Oral, 100 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 300 mg, once daily, 28 days; Drug: BMS-830216; Capsules, oral, 600 mg, once daily 28 days; Drug: BMS-830216; Capsules, oral, 1200 mg, once daily, 28 days; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 22, 2009
• First Submitted That Met QC Criteria: May 27, 2009
• First Posted (Estimate): May 28, 2009

Study Record Updates

• Last Update Posted (Estimate): November 4, 2015
• Last Update Submitted That Met QC Criteria: October 12, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: MB123-002