Safety Study of BMS-903452 in Healthy Subjects (Panel 1-7) & Relative Bioavailability of the Crystalline and Amorphous Forms of BMS-903452 [Panels 4, 6, 11 & 12(Part A)], and Subjects With Type 2 Diabetes Mellitus (Part B)
NCT ID: NCT01240980
Last Updated: 2012-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
104 participants
INTERVENTIONAL
2010-11-30
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BMS-903452 (0.1 mg) or Placebo - A1
(Healthy Subjects)
BMS-903452
Solution, Oral, 0.1 mg, once daily, 1 day
Placebo
Solution, Oral, 0 mg, once daily, 1 day
BMS-903452 (0.6 mg) or Placebo - A2
(Healthy Subjects)
BMS-903452
Solution, Oral, 0.6 mg, once daily, 1 day
Placebo
Solution, Oral, 0 mg, once daily, 1 day
BMS-903452 (3.0 mg) or Placebo - A3
(Healthy Subjects)
BMS-903452
Suspension, Oral, 3.0 mg, once daily, 1 day
Placebo
Suspension, Oral, 0 mg, once daily, 1 day
BMS-903452 (10 mg) or Placebo - A4
(Healthy Subjects)
BMS-903452
Suspension, Oral, 10 mg, once daily, 1 day
Placebo
Suspension, Oral, 0 mg, once daily, 1 day
BMS-903452 (30 mg) or Placebo - A5
(Healthy Subjects)
BMS-903452
Suspension, Oral, 30 mg, once daily, 1 day
Placebo
Suspension, Oral, 0 mg, once daily, 1 day
BMS-903452 (60 mg) or Placebo - A6
(Healthy Subjects)
BMS-903452
Suspension, Oral, 60 mg, once daily, 1 day
Placebo
Suspension, Oral, 0 mg, once daily, 1 day
BMS-903452 (120 mg) or Placebo - A7
(Healthy Subjects)
BMS-903452
Suspension, Oral, 120 mg, once daily, 1 day
Placebo
Suspension, Oral, 0 mg, once daily, 1 day
BMS-903452 (0.6 mg) or Placebo - B1
(Subjects with type 2 Diabetes Mellitus)
Placebo
Solution, Oral, 0 mg, once daily, 1 day
BMS-903452
Solution, Oral, 0.6 mg, once daily, 1 day
BMS-903452 (10 mg) or Placebo - B2
(Subjects with type 2 Diabetes Mellitus)
Placebo
Suspension, Oral, 0 mg, once daily, 1 day
BMS-903452
Suspension, Oral, 10 mg, once daily, 1 day
BMS-903452 (120 mg) or Placebo - B3
(Subjects with type 2 Diabetes Mellitus)
Placebo
Suspension, Oral, 0 mg, once daily, 1 day
BMS-903452
Suspension, Oral, 120 mg, once daily, 1 day
BMS-903452 (10 mg) or Placebo - A11
(Healthy Subjects)
BMS-903452
Suspension using crystalline form, Oral, 10 mg, once daily, 1 day
Placebo
Suspension using crystalline form, Oral, 0 mg, once daily, 1 day
BMS-903452 (60 mg) or Placebo - A12
(Healthy Subjects)
BMS-903452
Suspension using crystalline form, Oral, 60 mg, once daily, 1 day
Placebo
Suspension using crystalline form, Oral, 0 mg, once daily, 1 day
Interventions
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BMS-903452
Solution, Oral, 0.1 mg, once daily, 1 day
BMS-903452
Solution, Oral, 0.6 mg, once daily, 1 day
BMS-903452
Suspension, Oral, 3.0 mg, once daily, 1 day
BMS-903452
Suspension, Oral, 10 mg, once daily, 1 day
BMS-903452
Suspension, Oral, 30 mg, once daily, 1 day
BMS-903452
Suspension, Oral, 60 mg, once daily, 1 day
BMS-903452
Suspension, Oral, 120 mg, once daily, 1 day
Placebo
Solution, Oral, 0 mg, once daily, 1 day
Placebo
Suspension, Oral, 0 mg, once daily, 1 day
BMS-903452
Suspension using crystalline form, Oral, 10 mg, once daily, 1 day
BMS-903452
Suspension using crystalline form, Oral, 60 mg, once daily, 1 day
Placebo
Suspension using crystalline form, Oral, 0 mg, once daily, 1 day
BMS-903452
Solution, Oral, 0.6 mg, once daily, 1 day
BMS-903452
Suspension, Oral, 10 mg, once daily, 1 day
BMS-903452
Suspension, Oral, 120 mg, once daily, 1 day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of significant heart disease
* Prior bariatric surgery
* Women of childbearing potential
18 Years
65 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Comprehensive Phase One
Miramar, Florida, United States
Ppd Development, Lp
Austin, Texas, United States
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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MB125-001
Identifier Type: -
Identifier Source: org_study_id
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