A Study to Evaluate the Effect of BMS-986278 on Cardiac Repolarization in Healthy Participants

A Phase 1, Randomized, Double-blind, Positive-controlled, Placebo-controlled, 4-Period Crossover, Thorough QT/QTc Study to Evaluate the Effect of Multiple Doses of BMS-986278 on Cardiac Repolarization in Healthy Participants

The purpose of this study is to evaluate the effect of BMS-986278 on the cardiac repolarization in healthy participants.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: BMS-986278; Drug: Moxifloxacin

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78217
      • Recruiting
      • Worldwide Clinical Trials
      • Contact: Alan Hand, Site 0001; Phone Number: 210-635-1515

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria

• Female individuals not of childbearing potential and males.
• Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
• 18 to 55 years of age, inclusive, at the time of signing the informed consent with a BMI 18.0 to 32.0 kg/m2, inclusive.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment B	Drug: Placebo; Specified dose on specified days; Drug: BMS-986278; Specified dose on specified days
Experimental: Treatment A	Drug: BMS-986278; Specified dose on specified days
Placebo Comparator: Treatment C	Drug: Placebo; Specified dose on specified days
Experimental: Treatment D	Drug: Placebo; Specified dose on specified days; Drug: Moxifloxacin; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)	Up to Day 13
Placebo-corrected change from baseline QTcF (ΔΔQTcF)	Up to Day 13

Secondary Outcome Measures

Outcome Measure	Time Frame
Placebo-corrected change from baseline QTcF (ΔΔQTcF)	Up to Day 13
Change from baseline heart rate (HR)	Up to Day 13
Placebo-corrected change from baseline HR	Up to Day 13
Change from baseline PR interval	Up to Day 13
Placebo-corrected change from baseline PR interval	Up to Day 13
Change from baseline QRS interval	Up to Day 13
Placebo-corrected change from baseline QRS interval	Up to Day 13
Number of participants with categorical outliers for QTcF	Up to Day 13
Number of participants with categorical outliers for HR	Up to Day 13
Number of participants with categorical outliers for PR interval	Up to Day 13
Number of participants with categorical outliers for QRS interval	Up to Day 13
Number of participants with treatment-emergent changes of electrocardiogram (ECG) morphology	Up to Day 13
Change from baseline QTcF (ΔQTcF)	Up to Day 13
Number of participants with non-serious adverse events (AEs)	Up to approximately 17 weeks
Number of participants with Serious AEs (SAEs)	Up to approximately 17 weeks
Number of participants with AEs leading to study intervention discontinuation	Up to approximately 17 weeks
Number of participants with vital sign abnormalities	Up to approximately 17 weeks
Number of participants with clinical laboratory assessment abnormalities	Up to approximately 17 weeks
Number of participants with 12-lead ECG abnormalities	Up to approximately 17 weeks
Number of participants with physical examination abnormalities	Up to approximately 17 weeks
Maximum observed concentration (Cmax)	Up to Day 13
Time of maximum observed concentration (Tmax)	Up to Day 13
Area under the concentration-time curve in 1 dosing interval (AUC[TAU])	Up to Day 13

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 19, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Moxifloxacin
• Other Study ID Numbers: IM027-1055

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.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