The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), in healthy participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
ICON Lenexa
Lenexa, Kansas, United States
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 25
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 25
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 25
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 25
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 25
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 25
Number of participants with Adverse Events (AEs)
Time frame: Up to 28 days after last dose
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 28 days after last dose
Number of participants with AEs leading to discontinuation
Time frame: Up to 28 days after last dose
Number of participants with vital sign abnormalities
Time frame: Up to Day 25
Number of participants with 12-lead ECG assessment abnormalities
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Time frame: Up to Day 25
Number of participants with physical examination abnormalities
Time frame: Up to Day 25
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 25
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 25