NCT00909766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P75+ for phase_1 obesity

Timeline
Completed

Started Aug 2009

Typical duration for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 4, 2015

Status Verified

October 1, 2015

Enrollment Period

1.8 years

First QC Date

May 22, 2009

Last Update Submit

October 12, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (8)

Panel A

ACTIVE COMPARATOR
Drug: BMS-830216Drug: Placebo

Panel B

ACTIVE COMPARATOR
Drug: BMS-830216Drug: Placebo

Panel C

ACTIVE COMPARATOR
Drug: BMS-830216Drug: Placebo

Panel D

ACTIVE COMPARATOR
Drug: BMS-830216Drug: Placebo

Panel E

ACTIVE COMPARATOR
Drug: BMS-830216Drug: Placebo

Panel F

ACTIVE COMPARATOR

Low Dose

Drug: BMS-830216

Panel G

ACTIVE COMPARATOR

High Dose

Drug: BMS-830216

Panel H

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BMS-830216DRUG

Capsules, Oral, 30 mg, once daily, 28 days

Panel A
PlaceboDRUG

Capsules, Oral, 0 mg, once daily, 28 days

Panel APanel BPanel CPanel DPanel EPanel H

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2009

First Posted

May 28, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

November 4, 2015

Record last verified: 2015-10

Locations

US(1)