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)
NCT01240980 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2012-03-15
Summary
The purpose of this study is to evaluate the safety, tolerability and effect on blood glucose control of BMS-903452 compared to placebo in healthy subjects \& 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). The study will also determine the amount of BMS-903452 in the blood.
Conditions
Interventions
- DRUG
-
BMS-903452
Solution, Oral, 0.1 mg, once daily, 1 day
- DRUG
-
BMS-903452
Solution, Oral, 0.6 mg, once daily, 1 day
- DRUG
-
BMS-903452
Suspension, Oral, 3.0 mg, once daily, 1 day
- DRUG
-
BMS-903452
Suspension, Oral, 10 mg, once daily, 1 day
- DRUG
-
BMS-903452
Suspension, Oral, 30 mg, once daily, 1 day
- DRUG
-
BMS-903452
Suspension, Oral, 60 mg, once daily, 1 day
- DRUG
-
BMS-903452
Suspension, Oral, 120 mg, once daily, 1 day
- DRUG
-
Solution, Oral, 0 mg, once daily, 1 day
- DRUG
-
Suspension, Oral, 0 mg, once daily, 1 day
- DRUG
-
BMS-903452
Suspension using crystalline form, Oral, 10 mg, once daily, 1 day
- DRUG
-
BMS-903452
Suspension using crystalline form, Oral, 60 mg, once daily, 1 day
- DRUG
-
Suspension using crystalline form, Oral, 0 mg, once daily, 1 day
- DRUG
-
BMS-903452
Solution, Oral, 0.6 mg, once daily, 1 day
- DRUG
-
BMS-903452
Suspension, Oral, 10 mg, once daily, 1 day
- DRUG
-
BMS-903452
Suspension, Oral, 120 mg, once daily, 1 day
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2012-01-31
- Completion
- 2012-01-31
Countries
- United States
Study Locations
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