The purpose of this study is to assess the safety, tolerability and effect on Midazolam pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
24
Ppd Development, Lp
Austin, Texas, United States
Safety and tolerability measured by number of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters
Time frame: Up to 168 days
Safety and tolerability measured by percent of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters
Time frame: Up to 168 days
Maximum observed plasma concentration (Cmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Time of maximum observed plasma concentration (Tmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Area under the concentration-time curve from time zero to 24h [AUC(TAU)] of BMS-986120 and BMT-141464
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Concentration at the end of the dosing Interval (Ctau) of BMS-986120 and BMT-141464
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Half-life (T-HALF) of BMS-986120 and BMT-141464
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Apparent total body clearance (CLT/F) of BMS-986120, Midazolam, and 1'hydroxymidazolam
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUC accumulation index (AI_AUC) of BMS-986120 and BMT-141464
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986120
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMT-141464
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMT-141464
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Midazolam and 1'hydroxymidazolam
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Midazolam and 1'hydroxymidazolam
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight [MR_AUC(INF)] of 1'hydroxymidazolam
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Change from baseline in protease-activated receptor-4 - agonist peptide (PAR4-AP) induced platelet aggregation of BMS-986120
Time frame: Part A (Days 1-3) & Part B/C (Days 1-19)