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A Study to Investigate the Safety, Tolerability, and Drug Levels of BMS-986419 (Part 1) and the Effects Multiple Doses of BMS-986419 on Cardiac Repolarization (Part 2) in Healthy Participants

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NCT06846866

Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.

Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
74actual
Sites
1
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2025-02-27actualWhen the study began enrolling
Primary completion2025-10-21actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-10-21actualThe whole study's end, after follow-up
First posted2025-02-26actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-11-17actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Healthy Volunteers

Interventions

  • Drug: BMS-986419
  • Drug: BMS-986419 Matching Placebo
  • Drug: Moxifloxacin
  • Drug: Moxifloxacin Matching Placebo

Primary outcomes

what the primary-completion date above is the date OF
Part 1: Number of Participants with Non-serious Adverse Events (NSAEs)
measured Up to approximately Day 42
Part 1: Number of Participants with Serious Adverse Events (SAEs)
measured Up to approximately Day 42
Part 1: Number of Participants with AEs Leading to Discontinuation
measured Up to approximately Day 42
Part 1: Number of Participants With AEs of Special Interest (AESI)
measured Up to approximately Day 42
Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities
measured Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
measured Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
measured Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Columbia-Suicide Severity Rating Scale (C-SSRS) Abnormalities
measured Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Neurological Examination Abnormalities
measured Up to approximately Day 21
Part 1: Number of Participants With Physical Examination Abnormalities
measured 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)
measured 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
measured Up to approximately Day 15

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