The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
267
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
Anaheim, California, United States
Local Institution - 0003
Austin, Texas, United States
Incidence of adverse events (AEs)
Time frame: Up to 28 days
Incidence of serious adverse events (SAEs)
Time frame: Up to 28 days
Number of participants with vital sign abnormalities
Time frame: Up to 28 days
Number of participants with physical examination abnormalities
Time frame: Up to 28 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 28 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 28 days
Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 28 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 27
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 27
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Time frame: Up to Day 27
Cerebrospinal fluid (CSF) concentrations
Time frame: Up to Day 27
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Specified dose on specified days
Ratios of CSF to plasma concentrations
Time frame: Up to 9 days