BMS-820132 is an investigational new drug being developed by BMS for treating Type 2 diabetes. The purpose of this study is to test the safety/tolerability (potential side effects) of multiple doses of the investigational new drug, as well as the amount of study drug in the blood and its effects on blood sugar,in subjects with type 2 diabetes.
Study Classification: Safety, Pharmacokinetics/dynamics
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
67
capsule, Oral, 0.0mg, twice daily, 14 day
Capsule, Oral, 0.0mg, once daily, 14 day
Capsule, Oral, 15mg, twice daily, 14 day
Dedicated Phase I, Inc.
Phoenix, Arizona, United States
Osborne Research Center
Little Rock, Arkansas, United States
Clinical Pharmacology Of Miami Inc.
Miami, Florida, United States
Mra Clinical Research
Miami, Florida, United States
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
Time frame: Throughout the study drug administration period (14 days)
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
Time frame: within 7 days after the final dose
Maximum observed plasma concentration (Cmax) of BMS-820132
Time frame: Day 1 and Day 14
Time of maximum observed plasma concentration (Tmax) of BMS-820132
Time frame: Day 1 and Day 14
Trough observed plasma concentration (Cmin) of BMS-820132
Time frame: Day 1 through Day 14 (selected days)
Area under the plasma concentration-time curve over one dosing interval [AUC(TAU)] of BMS-820132
Time frame: Day 1 and Day 14
Accumulation index (AI) of BMS-820132
Time frame: Day 14
Half life (T-Half) of BMS-820132
Time frame: Day 14
AUC(0-24 h) and postprandial AUC(0-4h) for biomarkers of glucose homeostasis
Time frame: Day -1, Day 1, Day 7 and Day 14
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Capsule, Oral, 60mg, twice daily, 14 day
Capsule, oral, 150mg, twice daily, 14 day
Capsule, Oral, 300mg, twice daily, 14 day
Capsule, Oral, 450mg, twice daily, 14 day
Capsule, Oral, To be determined (TBD), once daily, 14 day
Capsule, Oral, 5 mg, twice daily, 14 day
Cetero Research
San Antonio, Texas, United States