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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Moxifloxacin; Drug: BMS-986419; Drug: BMS-986419 Matching Placebo; Drug: Moxifloxacin Matching Placebo

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
• Participants must have a Body mass index (BMI) between 18.0 and 30.0 kilograms/meter square (kg/m^2), inclusive, at screening.

Exclusion Criteria

• Participants must not have any significant acute or chronic medical illness as determined by the investigator.
• Participants must not have any current or recent (within 3 months of study intervention administration) GI disease, liver and kidney that could possibly affect drug absorption, distribution, metabolism, and excretion, (e.g., bariatric procedure, Cholecystectomy, and any other GI surgery that could impact upon the absorption of study intervention).
• Participants must not have Gilbert Syndrome.
• Participants must not have a history of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for ventricular arrhythmias (e.g., long QT syndrome, catecholamine polymorphic ventricular tachycardia).
• Participants must not have exposure to any investigational drug or placebo (other than BMS-986419 or moxifloxacin) within 4 weeks or 5 half-lives (whichever is longer) prior to Day -1 (Day -2 for Part 2) until follow-up phone call.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Administration of BMS-986419	Drug: BMS-986419; Specified dose on specified days
Placebo Comparator: Part 1: Administration of Placebo	Drug: BMS-986419 Matching Placebo; Specified dose on specified days
Experimental: Part 2: Group 1	Drug: BMS-986419; Specified dose on specified days; Drug: BMS-986419 Matching Placebo; Specified dose on specified days; Drug: Moxifloxacin Matching Placebo; Specified dose on specified days
Experimental: Part 2: Group 2a	Drug: Moxifloxacin; Specified dose on specified days; Drug: BMS-986419 Matching Placebo; Specified dose on specified days; Drug: Moxifloxacin Matching Placebo; Specified dose on specified days
Experimental: Part 2: Group 2b	Drug: Moxifloxacin; Specified dose on specified days; Drug: BMS-986419 Matching Placebo; Specified dose on specified days; Drug: Moxifloxacin Matching Placebo; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of Participants with Non-serious Adverse Events (NSAEs)		Up to approximately Day 42
Part 1: Number of Participants with Serious Adverse Events (SAEs)		Up to approximately Day 42
Part 1: Number of Participants with AEs Leading to Discontinuation		Up to approximately Day 42
Part 1: Number of Participants With AEs of Special Interest (AESI)		Up to approximately Day 42
Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities	Vital sign parameters include temperature, systolic blood pressure (BP), diastolic BP, respiratory rate, and heart rate (HR) assessment.	Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities		Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities		Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Columbia-Suicide Severity Rating Scale (C-SSRS) Abnormalities		Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Neurological Examination Abnormalities		Up to approximately Day 21
Part 1: Number of Participants With Physical Examination Abnormalities		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)	ΔQTc is performed by primary correction.	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		Up to approximately Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986419		Up to approximately Day 21
Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986419		Up to approximately Day 21
Part 1: Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) of BMS-986419		Up to approximately Day 21
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986419		Up to approximately Day 21
Part 1: Terminal Phase Elimination Half-life (T-Half) of BMS-986419		Up to approximately Day 21
Part 1: Accumulation Index; Ratio of Cmax at Steady-state to Cmax After the First Dose (AI_Cmax) of BMS-986419		Up to approximately Day 21
Part 1: Accumulation Index; Ratio of AUC(TAU) at Steady-state to AUC(TAU) After the First Dose [AI_AUC(TAU)] of BMS-986419		Up to approximately Day 21
Part 1: Apparent Total Body Clearance (CLT/F) of BMS-986419		Up to approximately Day 21
Part 1: Apparent Volume of Distribution of Terminal Phase (Vz/F) of BMS-986419		Up to approximately Day 21
Part 1: Trough Concentration of BMS-986419		Up to approximately Day 21
Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Heart Rate (HR)(ΔHR) Correction		Up to approximately Day 15
Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Pulse Rate (PR)(ΔPR) Correction		Up to approximately Day 15
Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Respiratory Rate (RR) Interval Correction		Up to approximately Day 15
Part 2: Change From Baseline of BMS-986419 in Quality Rating System (QRS) Interval (ΔQRS)		Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of Fridericia's Corrected QT interval (QTcF) for BMS-986419	Participants with increase in absolute treatment-emergent QTc values >450 and ≤480 milliseconds (msec), >480 and ≤500 msec, or >500 msec, and changes from pre-dose baseline of >30 and ≤ 60 msec, or >60 msec will be measured.	Up to approximately Day 15
Part 2: Number of Timepoints With Change in Absolute Treatment-emergent QTcF Values for BMS-986419	Number of timepoints with increase in absolute treatment-emergent QTc values >450 and ≤480 milliseconds (msec), >480 and ≤500 msec, or >500 msec, and changes from pre-dose baseline of >30 and ≤ 60 msec, or >60 msec will be measured.	Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of Individualized Heart Rate-corrected Interval/Optimized HR-corrected QT Interval (QTcS/QTcI) for BMS-986419		Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of HR for BMS-986419	Participants with decrease in HR from pre-dose baseline >25% to a HR <50 beats per minute (bpm); and increase in HR from pre-dose baseline >25% to a HR >100 bpm will be determined.	Up to approximately Day 15
Part 2: Number of Timepoints With Change in Absolute Treatment-emergent HR Values for BMS-986419	Number of timepoints with decrease in HR from pre-dose baseline >25% to a HR <50 beats per minute (bpm); and increase in HR from pre-dose baseline >25% to a HR >100 bpm will be determined.	Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of PR for BMS-986419	Participants with increase in PR from pre-dose baseline >25% to a PR>200 msec will be determined.	Up to approximately Day 15
Part 2: Number of Timepoints With Increase in Absolute Treatment-emergent PR Values for BMS-986419	Number of timepoints with increase in PR from pre-dose baseline >25% to a PR>200 msec will be determined.	Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of QRS for BMS-986419	Participants with increase in QRS from pre-dose baseline >25% to a QRS >120 msec will be determined.	Up to approximately Day 15
Part 2: Number of Timepoints With Increase in Absolute Treatment-emergent QRS Values for BMS-986419	Number of timepoints with increase in QRS from pre-dose baseline >25% to a QRS >120 msec will be determined.	Up to approximately Day 15
Part 2: Number of Participants With New Onset ECG Morphology Findings	"New" means an ECG finding that is not present on any baseline ECG [that is, any ECG recorded prior to receipt of the first dose of study BMS-986419] and becomes present on at least 1 on-treatment ECG during that treatment period).	Up to approximately Day 15
Part 2: ΔQTc: Change From Baseline in Plasma Concentration of Moxifloxacin on Cardiac Repolarization Expressed by QT interval (QTc)	ΔQTc is performed by primary correction.	Up to approximately Day 15
Part 2: ΔΔQTc: Placebo-corrected Change From Baseline QTc Plasma Concentration of Moxifloxacin on Cardiac Repolarization Expressed by QTc		Up to approximately Day 15
Part 2: Number of Participants with NSAEs		Up to approximately Day 36
Part 2: Number of Participants with SAEs		Up to approximately Day 36
Part 2: Number of Participants with AEs Leading to Discontinuation		Up to approximately Day 36
Part 2: Number of Participants With AESI		Up to approximately Day 36
Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities	Vital sign parameters include temperature, systolic BP, diastolic BP, respiratory rate, and HR assessment.	Up to approximately Day 15
Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities		Up to approximately Day 14
Part 2: Number of Participants With Clinically Significant 12-Lead ECG Abnormalities		Up to approximately Day 15
Part 2: Number of Participants With Clinically Significant C-SSRS Abnormalities		Up to approximately Day 15
Part 2: Number of Participants With Clinically Significant Neurological Examination Abnormalities		Up to approximately Day 15
Part 2: Number of Participants With Physical Examination Abnormalities		Up to approximately Day 15
Part 2: Cmax of BMS-986419		Up to approximately Day 15
Part 2: Tmax of BMS-986419		Up to approximately Day 15
Part 2: AUC(0-T) of BMS-986419		Up to approximately Day 15
Part 2: AUC(TAU) of BMS-986419		Up to approximately Day 15
Part 2: T-Half of BMS-986419		Up to approximately Day 15
Part 2: AI_Cmax of BMS-986419		Up to approximately Day 15
Part 2: AI_AUC(TAU) of BMS-986419		Up to approximately Day 15
Part 2: Trough Concentration of BMS-986419		Up to approximately Day 15

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Actual): October 21, 2025
• Study Completion (Actual): October 21, 2025

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: BMS-986419, healthy, QTC, pharmacokinetics, moxifloxacin
• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Moxifloxacin
• Other Study ID Numbers: CN007-1005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No