The purpose of this study is to evaluate the safety, tolerability, and drug levels of orally administered BMS-986368 in healthy participants, healthy elderly participants, and healthy participants of japanese ethnicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Specified dose on specified days
Local Institution - 0001
Anaheim, California, United States
Number of participants with adverse events (AEs)
Time frame: Up to 44 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 44 days
Number of participants with vital sign (VS) abnormalities
Time frame: Up to 21 days
Number of participants with physical examination abnormalities
Time frame: Up to 21 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 21 days
Number of participants with clinical laboratory asssement abnormalities
Time frame: Up to 21 days
Number of participants with treatment-emergent suicidal ideation and behavior through assessment of Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 21 days
Area under the plasma concentration-time curve (AUC)
Time frame: Up to 16 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 16 days
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 16 days
Absolute levels of monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)
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Time frame: Up to 21 days
Percent change from baseline for monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)
Time frame: Up to 21 days
Plasma concentrations of anandamide (AEA)
Time frame: Up to 21 days
Percent change from baseline of anandamide (AEA)
Time frame: Up to 21 days
Whole blood concentrations of 2-arachidonoylglycerol (2-AG)
Time frame: Up to 21 days
Percent change from baseline of 2-arachidonoylglycerol (2-AG)
Time frame: Up to 21 days