Clinical trial NCT00909766: Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obesity
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-05-28
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Safety: safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations and clinical laboratory tests
timeFrame: Within 2 weeks after study drug administration
Secondary outcomes:
measure: Pharmacokinetics: to assess the multiple-dose PK of BMS-830216
timeFrame: Within 2 weeks of study drug administration
measure: Pharmacodynamics: to assess the pharmacodynamic effect of BMS-830216 on body weight and BMI over 4 weeks of therapy
timeFrame: Within 2 weeks of study drug administration
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: