The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.
Maximum Age: Part A SAD 65 years Part B MAD 75 years Part C MAD Japanese 75 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
148
West Coast Clinical Trials, Llc
Cypress, California, United States
Ppd Development, Lp
Austin, Texas, United States
Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Serious adverse event (SAE) Adverse event (AE) Electrocardiogram (ECG)
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
Safety measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
Tolerability measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
Maximum observed plasma concentration (Cmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
Time of maximum observed plasma concentration (Tmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to Day 14
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
Concentration at 24 hours (C24) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
Half-life (T-HALF) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
AUC accumulation index (AI_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose
Time frame: Up to Day 14
Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
MR_Cmax of BMT-162853, BMT-162856, and BMT-181551
Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR\_Cmax)
Time frame: Up to Day 14
MR_AUC(INF) of BMT-162853, BMT-162856, and BMT-181551
Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight \[MR\_AUC(INF)\]
Time frame: Up to Day 14
MR_AUC(0-T) of BMT-162853, BMT-162856, and BMT-181551
Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight \[MR\_AUC(0-T)\]
Time frame: Up to Day 14
MR_AUC(TAU) of BMT-162853, BMT-162856, and BMT-181551
Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight \[MR\_AUC(TAU)\]
Time frame: Up to Day 14
Safety of multiple doses of BMS-986141 and aspirin in healthy subjects
Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations.
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
Tolerability of multiple doses of BMS-986141 and aspirin in healthy subjects
Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
Safety of BMS-986141 and itraconazole in healthy subjects
Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
Tolerability of BMS-986141 and itraconazole in healthy subjects
Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study