The purpose of this study is to investigate the safety and tolerability of BMS-986209 in healthy participants. The first-in-human study is designed in 3 parts that vary based on duration and food effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
Specified Dose on Specified Days
Specified Dose on Specified Days
Specified Dose on Specified Days
PPD Development, LP
Austin, Texas, United States
Incidence of Adverse Events (AEs) including bleeding
Time frame: Up to 18 days
Incidence of serious AEs (SAEs)
Time frame: Up to 44 days
Incidence of AEs leading to discontinuation
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Respiratory Rate
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Seated blood pressure
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Resting pulse rate
Time frame: Up to 18 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Time frame: Up to 18 days
Incidence of clinically significant changes in clinical laboratory tests: Hematology tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests
Time frame: Up to 16 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Specified Dose on Specified Days
Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serology tests
Time frame: Up to 16 days
Maximum observed plasma concentration (Cmax) of BMS-986209
Time frame: Up to 18 days
Time of Maximum observed plasma concentration (Tmax) of BMS-986209
Time frame: Up to 18 days
Terminal plasma half-life (T-Half) of BMS-986209
Time frame: Up to 18 days
Incidence of Adverse Events (AEs) including bleeding
Time frame: Up to 18 days
Incidence of serious AEs (SAEs)
Time frame: Up to 44 days
Incidence of AEs leading to discontinuation
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Respiratory Rate
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Seated blood pressure
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Resting pulse rate
Time frame: Up to 18 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Time frame: Up to 18 days
Incidence of clinically significant changes in clinical laboratory tests: Hematology tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serology tests
Time frame: Up to 16 days
Percent change from baseline in plasma activated partial thromboplastin time (aPTT) levels
Time frame: Up to 16 days
Percent change from baseline in factor XI (FXI) clotting activity
Time frame: Up to 16 days