A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac Repolarization in Healthy Participants

A Phase 1, Two-Part, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986278 (Part A) and a 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 (Part B) in Healthy Participants

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) of high dose of BMS-986278 in healthy participants and to assess the effect of BMS-986278 on the ECG intervals in healthy participants.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • ICON San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Female individuals not of childbearing potential (INOCBP) and males.
• Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
• Body mass index (BMI) 18.0 to 32.0 kg/m2 , inclusive, for Parts A and B.

Exclusion Criteria:

• Any significant acute or chronic medical illness as determined by the investigator.
• 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.
• Any significant history of disease of the cardiovascular system that in the opinion of the Investigator makes the participant unsuitable for enrollment into the study.
• 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

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A	Drug: Placebo; Specified dose on specified days; Drug: BMS-986278; Specified dose on specified days
Experimental: Part B1/B2 Treatment A	Drug: BMS-986278; Specified dose on specified days
Experimental: Part B1/B2 Treatment B	Drug: Placebo; Specified dose on specified days; Drug: BMS-986278; Specified dose on specified days
Experimental: Part B1/B2 Treatment C	Drug: Placebo; Specified dose on specified days
Experimental: Part B1/B2 Treatment D	Drug: Placebo; Specified dose on specified days; Drug: Moxifloxacin; Specified dose on specified days
Experimental: Part B3 Treatment A	Drug: BMS-986278; Specified dose on specified days
Experimental: Part B3 Treatment B	Drug: Placebo; Specified dose on specified days; Drug: BMS-986278; Specified dose on specified days
Experimental: Part B3 Treatment C	Drug: Placebo; Specified dose on specified days
Experimental: Part B3 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	Measure Description	Time Frame
Number of participants with non-serious Adverse Events (AEs)	Part A	Until 28 days post last treatment dose
Number of participants with Serious AEs (SAEs)	Part A	Until 28 days post last treatment dose
Number of participants with AEs leading to study intervention discontinuation	Part A	Until 28 days post last treatment dose
Number of participants with vital sign abnormalities	Part A	Up to Day 18
Number of participants with clinical laboratory assessment abnormalities	Part A	Up to Day 18
Number of participants with 12-lead electrocardiogram (ECG) abnormalities	Part A	Up to Day 18
Number of participants with physical examination abnormalities	Part A	Up to Day 18
Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Placebo-corrected change from baseline QTcF (ΔΔQTcF)	Part B	Up to Day 13 of Period 4 (Each period is 17 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax)	Part A and Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Time of maximum observed plasma concentration (Tmax)	Part A and Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Area under the plasma concentration-time curve from time zero to the end of dosing interval AUC(TAU)	Part A and Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Terminal half-life (T-HALF)	Part A	Up to Day 18
Apparent total body clearance (CLT/F)	Part A	Up to Day 18
Change from baseline heart rate (HR) (∆HR)	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Change from baseline PR interval (∆PR)	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Change from baseline QRS interval (∆QRS)	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Placebo-corrected change from baseline HR (ΔΔHR)	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Placebo-corrected Change from baseline PR interval (ΔΔPR)	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Placebo-corrected change from baseline QRS interval (ΔΔQRS)	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with categorical outliers for QTcF	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with categorical outliers for HR	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with categorical outliers for PR interval	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with categorical outliers for QRS interval	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with treatment-emergent changes of ECG morphology	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
ΔQTcF for moxifloxacin	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
ΔΔQTcF for moxifloxacin	Part B	Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with non-serious AEs	Part B	Until 28 days post last treatment dose
Number of participants with SAEs	Part B	Until 28 days post last treatment dose
Number of participants with AEs leading to study intervention discontinuation	Part B	Until 28 days post last treatment dose
Number of participants with vital sign abnormalities	Part B	Up to Day 18 of Period 4 (Each period is 17 days)
Number of participants with clinical laboratory assessment abnormalities	Part B	Up to Day 17 of Period 4 (Each period is 17 days)
Number of participants with 12-lead ECG abnormalitie	Part B	Up to Day 17 of Period 4 (Each period is 17 days)
Number of participants with physical examination abnormalities	Part B	Up to Day 18 of Period 4 (Each period is 17 days)

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 10, 2025
• Primary Completion (Actual): September 11, 2025
• Study Completion (Actual): September 11, 2025

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: September 1, 2025

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: IM027-1012

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/disclosurecommitment.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