Text Size

Safety Study to Evaluate BMS-830216 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00878020
First received: April 2, 2009
Last updated: February 22, 2011
Last verified: November 2009
History of Changes

April 2, 2009
February 22, 2011
May 2009
September 2009   (final data collection date for primary outcome measure)
Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results [ Time Frame: Within the 10 days after study drug administration ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00878020 on ClinicalTrials.gov Archive Site
Pharmacokinetic profile (drug absorption, distribution, metabolism and excretion process) determined by plasma concentration vs. time profile from a series of plasma samples up to 10 days post dose [ Time Frame: Within the 10 days after study drug administration ] [ Designated as safety issue: No ]
Same as current
 
 
 
Safety Study to Evaluate BMS-830216 in Healthy Subjects
Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-830216 (Pro-Drug of BMS-819881) in Healthy Subjects

The purpose of this study is to evaluate the safety profile, tolerability, and pharmacokinetics of single oral doses from 10 mg up to 1200 mg of BMS-830216 (pro-drug of BMS-819881) in healthy subjects
 
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obesity
  • Drug: BMS-830216
    Capsules, Oral, Single Dose, 1 day
  • Drug: Placebo
    Capsules, Oral, 0mg, Single Dose, 1 day
  • Drug: BMS-830216
    Capsules, Oral, Single Dose on Day 1, Period 1 and Day 1, Period 2, 2 days
  • Drug: Placebo
    Capsules, Oral, 0mg, Single Dose, on Day 1, Period 1 and Day 1, Period 2, 2 days
  • Active Comparator: Arm 1
    BMS-830216 (10 mg)
    Interventions:
    • Drug: BMS-830216
    • Drug: Placebo
  • Active Comparator: Arm 2
    BMS-830216 (30 mg)
    Interventions:
    • Drug: BMS-830216
    • Drug: Placebo
  • Active Comparator: Arm 3
    BMS-830216 (100 mg)
    Interventions:
    • Drug: BMS-830216
    • Drug: Placebo
  • Active Comparator: Arm 4
    BMS-830216 (300 mg)
    Interventions:
    • Drug: BMS-830216
    • Drug: Placebo
  • Active Comparator: Arm 5
    BMS-830216 (600 mg)
    Interventions:
    • Drug: BMS-830216
    • Drug: Placebo
  • Active Comparator: Arm 6
    BMS-830216 (1200 mg)
    Interventions:
    • Drug: BMS-830216
    • Drug: Placebo
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
  • Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men between ages of 18 to 45

Exclusion Criteria:

  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00878020
MB123-001
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
 
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP