The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of BMS-986419 (Part 1) and the effects of multiple doses of BMS-986419 on cardiac repolarization (Part 2) in healthy participants.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Part 1: Number of Participants with Non-serious Adverse Events (NSAEs)
Timeframe: Up to approximately Day 42
Part 1: Number of Participants with Serious Adverse Events (SAEs)
Timeframe: Up to approximately Day 42
Part 1: Number of Participants with AEs Leading to Discontinuation
Timeframe: Up to approximately Day 42
Part 1: Number of Participants With AEs of Special Interest (AESI)
Timeframe: Up to approximately Day 42
Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities
Timeframe: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Timeframe: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
Timeframe: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Columbia-Suicide Severity Rating Scale (C-SSRS) Abnormalities
Timeframe: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Neurological Examination Abnormalities
Timeframe: Up to approximately Day 21
Part 1: Number of Participants With Physical Examination Abnormalities
Timeframe: Up to approximately Day 21
Part 2: ΔQTc: Change From Baseline in Plasma Concentration of BMS-986419 on Cardiac Repolarization Expressed by QT interval (QTc)
Timeframe: Up to approximately Day 15
Part 2: ΔΔQTc: Placebo-corrected Change From Baseline QTc Plasma Concentration of BMS-986419 on Cardiac Repolarization Expressed by QTc
Timeframe: Up to approximately Day 15