This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Single dose with varying frequency among groups
Specified dose on specified days
PRA Health Sciences - Lenexa
Lenexa, Kansas, United States
Maximum observed plasma concentration of BMS-963272 (Cmax)
Time frame: Day 1, Day 14
Time of maximum observed concentration of BMS-963272 (Tmax)
Time frame: Day 1, Day 14
Area under the concentration-time curve in one dosing interval (AUC(TAU))
Time frame: Day 1, Day 14
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Time frame: Day 14
Apparent total clearance of the drug from plasma after oral administration (CLss/F)
Time frame: Day 14
Apparent volume of distribution at steady state (Vss/F)
Time frame: Day 14
Average concentration at steady state (Cavg,ss)
Time frame: Day 14
Half-life (T-HALF)
Time frame: Day 14
Accumulation index (AI)
Time frame: Day 14
Rate elimination constant (kel) of BMS-963272
Time frame: Day 14
Area under the concentration-time curve (AUC) of triglycerides (TG) and fatty acids in response to the oral lipid tolerance test (oLTT)
Time frame: Day 7, Day 15
Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT
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Time frame: Day 7, Day 15
Incidence of Adverse Events (AEs)
Time frame: Up to 55 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 55 days
Number of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests
Time frame: Up to 55 days