The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effect of BMS-986278 in healthy adult participants and Japanese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Altasciences Clinical Los Angeles, Inc
Cypress, California, United States
Syneos Health Clinical Research Services, Llc
Miami, Florida, United States
Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1)
Time frame: Up to 16 days
Maximum observed plasma concentration (Cmax) (Part 2)
Time frame: Up to 14 days
Time of maximum observed plasma concentration (Tmax) (Part 2)
Time frame: Up to 14 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) (Part 2)
Time frame: Up to 14 days
Cmax (Part 1 and 2)
Time frame: Up to 16 days
Tmax (Part 1)
Time frame: Up to 16 days
AUC(0-T) (Part 1)
Time frame: Up to 16 days
Number of participants with adverse events (AEs) (Part 1 and 2)
Time frame: 30 days after last dose
Number of participants with serious adverse events (SAEs) (Part 1 and 2)
Time frame: 30 days after last dose
Number of participants with clinical laboratory abnormalities (Part 1 and 2)
Time frame: 30 days after last dose
Number of participants with physical examination abnormalities (Part 1 and 2)
Time frame: 30 days after last dose
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Number of participants with vital sign abnormalities (Part 1 and 2)
Time frame: 30 days after last dose
Number of participants with electrocardiogram (ECG) abnormalities (Part 1 and 2)
Time frame: 30 days after last dose
Mean placebo-corrected change in diastolic blood pressure (DBP) (Part 1)
Time frame: 30 days after last dose
Area under the concentration-time curve in 1 dosing interval (AUC [TAU]) (Part 2)
Time frame: Up to 14 days