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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
Solution, Oral, 0.1 mg, once daily, 1 day
Solution, Oral, 0.6 mg, once daily, 1 day
Suspension, Oral, 3.0 mg, once daily, 1 day
Suspension, Oral, 10 mg, once daily, 1 day
Suspension, Oral, 30 mg, once daily, 1 day
Suspension, Oral, 60 mg, once daily, 1 day
Suspension, Oral, 120 mg, once daily, 1 day
Solution, Oral, 0 mg, once daily, 1 day
Suspension, Oral, 0 mg, once daily, 1 day
Suspension using crystalline form, Oral, 10 mg, once daily, 1 day
Suspension using crystalline form, Oral, 60 mg, once daily, 1 day
Suspension using crystalline form, Oral, 0 mg, once daily, 1 day
Solution, Oral, 0.6 mg, once daily, 1 day
Suspension, Oral, 10 mg, once daily, 1 day
Suspension, Oral, 120 mg, once daily, 1 day
Comprehensive Phase One
Miramar, Florida, United States
Ppd Development, Lp
Austin, Texas, United States
Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
Time frame: Within 10 days of study drug administration
Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism
Time frame: Within 2 days of study drug administration
Effect on electrocardiographic (ECG) parameters
Time frame: Within 10 days of study drug administration
Percent urinary recovery (% UR)
derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses
Time frame: Within 10 days of study drug administration
Renal clearance (CLR) from plasma
derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses
Time frame: Within 10 days of study drug administration
The single-dose pharmacokinetics parameter maximum observed concentration in plasma (Cmax) of BMS-903452 will be derived from the plasma concentration versus time data
Time frame: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter time to reach maximum observed concentration in plasma (Tmax) of BMS-903452 will be derived from the plasma concentration versus time data
Time frame: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter time Area under the plasma concentration-time curve from time zero extrapolated to infinity AUC(INF) of BMS-903452 will be derived from the plasma concentration versus time data
Time frame: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter Area under the plasma concentration-time curve from time zero to last measurable sampling time AUC (0-T) of BMS-903452 will be derived from the plasma concentration versus time data
Time frame: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter Terminal-phase elimination half-life in plasma (T-Half) of BMS-903452 will be derived from the plasma concentration versus time data
Time frame: Within 10 days after study drug administration
The single-dose pharmacokinetics parameter apparent clearance from plasma after extra-vascular administration (CLT/F) of BMS-903452 will be derived from the plasma concentration versus time data
Time frame: Within 10 days after study drug administration
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