A Study assessing the drug levels and drug effects of variable doses of BMS-986322 in Healthy Participants compared to a placebo. The study also assesses how BMS-986322 affects the body with food and its acidity levels.
Recruitment temporarily on hold due to COVID-19. This is a randomized, double-blind, placebo-controlled study which will investigate the safety, tolerability, and PK of single and multiple oral doses of BMS-986322 in healthy subjects. The trial consists of three parts: Part A - a single ascending dose (SAD) safety and pharmacokinetic (PK) evaluation; Part B -a multiple ascending dose (MAD) safety, PK, and pharmacodynamic (PD) evaluation; and Part C - effect of food and pH on PK and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
171
Specified Dose on Specified Days
Specified Dose on Specified Days
Specified Dose on Specified Days
ICON (LPRA) - Lenexa
Lenexa, Kansas, United States
Incidence of Death
Time frame: up to 12 months
Incidence of Adverse Effects (AEs)
Time frame: up to 12 months
Incidence of Adverse Events leading to discontinuation
Time frame: up to 12 months
Incidence of Serious Adverse Events (SAEs)
Time frame: up to 12 months
Vital signs of body temperature
Time frame: up to 12 months
Vital signs of blood pressure
Time frame: up to 12 months
Vital signs of respiratory rate
Time frame: up to 12 months
Number of Participants with abnormal physical examinations
Time frame: up to 12 months
Number of clinically significant changes in Electrocardiograms (ECGs)
Time frame: up to 12 months
Number of clinically significant changes in lab assessment of blood serum
Time frame: up to 12 months
Number of clinically significant changes in lab assessment of urine
Time frame: up to 12 months
Number of Clinically significant changes in lab assessment of blood
Time frame: up to 12 months
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Maximum concentration (Cmax) of BMS-986322 in Part C
Time frame: up to 12 months
Time of maximum concentration (Tmax) of BMS-986322 in Part C
Time frame: up to 12 months
Terminal elimination rate constant (Lambda_z) of BMS-986322 in Part C
Time frame: up to 12 months
Terminal elimination half-life (T-Half) of BMS-986322 in Part C
Time frame: up to 12 months
Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] of BMS-986322 in Part C
Time frame: up to 12 months
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)] of BMS-986322 in Part C
Time frame: up to 12 months
Apparent oral clearance (CL/F) of BMS-986322 in Part C
Time frame: up to 12 months
Apparent volume of distrubution at terminal phase (Vz/F) of BMS-986322 in Part C
Time frame: up to 12 months