A Phase 1, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986419 (Part 1) and a Phase 1 Randomized, Double-blind, Positive-controlled, Placebo-controlled, Parallel, Nested-crossover (Moxifloxacin-placebo) Thorough QT/QTc Study to Evaluate the Effect of Multiple Doses of BMS-986419 on Cardiac Repolarization (Part 2) in Healthy Participants
Abstract
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.
Conditions: Healthy Volunteers.
Primary outcome: Part 1: Number of Participants with Non-serious Adverse Events (NSAEs); Part 1: Number of Participants with Serious Adverse Events (SAEs); Part 1: Number of Participants with AEs Leading to Discontinuation; Part 1: Number of Participants With AEs of Special Interest (AESI); Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities; Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities; Part 1: Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities; Part 1: Number of Participants With Clinically Significant Columbia-Suicide Severity Rating Scale (C-SSRS) Abnormalities; Part 1: Number of Participants With Clinically Significant Neurological Examination Abnormalities; Part 1: Number of Participants With Physical Examination Abnormalities; Part 2: ΔQTc: Change From Baseline in Plasma Concentration of BMS-986419 on Cardiac Repolarization Expressed by QT interval (QTc); Part 2: ΔΔQTc: Placebo-corrected Change From Baseline QTc Plasma Concentration of BMS-986419 on Cardiac Repolarization Expressed by QTc.
Enrollment: 74 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 74 participants or records.
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