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Safety Study to Evaluate BMS-830216 in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00878020
First Posted: April 8, 2009
Last Update Posted: February 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00878020     History of Changes
Other Study ID Numbers: MB123-001
First Submitted: April 2, 2009
First Posted: April 8, 2009
Last Update Posted: February 23, 2011
Last Verified: November 2009