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
1 other identifier
interventional
48
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 obesity
Started May 2009
Shorter than P25 for phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2009
CompletedFirst Posted
Study publicly available on registry
April 8, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFebruary 23, 2011
November 1, 2009
4 months
April 2, 2009
February 22, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results
Within the 10 days after study drug administration
Secondary Outcomes (1)
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
Within the 10 days after study drug administration
Study Arms (6)
Arm 1
ACTIVE COMPARATORBMS-830216 (10 mg)
Arm 2
ACTIVE COMPARATORBMS-830216 (30 mg)
Arm 3
ACTIVE COMPARATORBMS-830216 (100 mg)
Arm 4
ACTIVE COMPARATORBMS-830216 (300 mg)
Arm 5
ACTIVE COMPARATORBMS-830216 (600 mg)
Arm 6
ACTIVE COMPARATORBMS-830216 (1200 mg)
Interventions
Eligibility Criteria
You may qualify if:
- 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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ppd Development, Lp
Austin, Texas, 78744, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 2, 2009
First Posted
April 8, 2009
Study Start
May 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
February 23, 2011
Record last verified: 2009-11