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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
  Purpose

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


Condition Intervention Phase
Obesity
 Drug: BMS-830216
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: May 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
BMS-830216 (10 mg)
 Drug: BMS-830216
Capsules, Oral, Single Dose, 1 day
Drug: Placebo
Capsules, Oral, 0mg, Single Dose, 1 day
Active Comparator: Arm 2
BMS-830216 (30 mg)
 Drug: BMS-830216
Capsules, Oral, Single Dose, 1 day
Drug: Placebo
Capsules, Oral, 0mg, Single Dose, 1 day
Active Comparator: Arm 3
BMS-830216 (100 mg)
 Drug: BMS-830216
Capsules, Oral, Single Dose, 1 day
Drug: Placebo
Capsules, Oral, 0mg, Single Dose, 1 day
Active Comparator: Arm 4
BMS-830216 (300 mg)
 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 5
BMS-830216 (600 mg)
 Drug: BMS-830216
Capsules, Oral, Single Dose, 1 day
Drug: Placebo
Capsules, Oral, 0mg, Single Dose, 1 day
Active Comparator: Arm 6
BMS-830216 (1200 mg)
 Drug: BMS-830216
Capsules, Oral, Single Dose, 1 day
Drug: Placebo
Capsules, Oral, 0mg, Single Dose, 1 day

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878020

Locations
United States, Texas
Ppd Development, Lp
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00878020     History of Changes
Other Study ID Numbers: MB123-001
Study First Received: April 2, 2009
Last Updated: February 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013