Clinical Trials/NCT00909766

NCT00909766

Completed

Phase 1

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

Bristol-Myers Squibb1 site in 1 country113 target enrollmentAugust 2009

ConditionsObesity

InterventionsBMS-830216 Placebo

DrugsBMS-830216 Placebo

Overview

Phase: Phase 1
Intervention: BMS-830216
Conditions: Obesity
Sponsor: Bristol-Myers Squibb
Enrollment: 113
Locations: 1
Primary Endpoint: Safety: safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations and clinical laboratory tests
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

June 2011

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

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

Arms & Interventions

Panel A

Intervention: BMS-830216

Panel A

Intervention: Placebo

Panel B

Intervention: BMS-830216

Panel B

Intervention: Placebo

Panel C

Intervention: BMS-830216

Panel C

Intervention: Placebo

Panel D

Intervention: BMS-830216

Panel D

Intervention: Placebo

Panel E

Intervention: BMS-830216

Panel E

Intervention: Placebo

Panel F

Low Dose

Intervention: BMS-830216

Panel G

High Dose

Intervention: BMS-830216

Panel H

Intervention: Placebo

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)