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

NCT06746402 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IM027-1012
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (25)

• Maximum observed plasma concentration (Cmax)

  Up to Day 13 of Period 4 (Each period is 17 days)

• Time of maximum observed plasma concentration (Tmax)

  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)

  Up to Day 13 of Period 4 (Each period is 17 days)

• Terminal half-life (T-HALF)

  Up to Day 18

• Apparent total body clearance (CLT/F)

  Up to Day 18

Study Arms (9)

Part A

EXPERIMENTAL

Drug: BMS-986278; Drug: Placebo

Part B1/B2 Treatment A

EXPERIMENTAL

Drug: BMS-986278

Part B1/B2 Treatment B

EXPERIMENTAL

Drug: BMS-986278; Drug: Placebo

Part B1/B2 Treatment C

EXPERIMENTAL

Drug: Placebo

Part B1/B2 Treatment D

EXPERIMENTAL

Drug: Placebo; Drug: Moxifloxacin

Part B3 Treatment A

EXPERIMENTAL

Drug: BMS-986278

Part B3 Treatment B

EXPERIMENTAL

Drug: BMS-986278; Drug: Placebo

Part B3 Treatment C

EXPERIMENTAL

Drug: Placebo

Part B3 Treatment D

EXPERIMENTAL

Drug: Placebo; Drug: Moxifloxacin

Interventions

BMS-986278 DRUG

Specified dose on specified days

Part A; Part B1/B2 Treatment A; Part B1/B2 Treatment B; Part B3 Treatment A; Part B3 Treatment B

Placebo DRUG

Specified dose on specified days

Part A; Part B1/B2 Treatment B; Part B1/B2 Treatment C; Part B1/B2 Treatment D; Part B3 Treatment B; Part B3 Treatment C; Part B3 Treatment D

Moxifloxacin DRUG

Specified dose on specified days

Part B1/B2 Treatment D; Part B3 Treatment D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

ICON San Antonio

San Antonio, Texas, 78209, United States

Location

Local Institution - 0001

Salt Lake City, Utah, 84124, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study, with an open-label positive control in Part B.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A, a parallel model, will be followed by Part B, a 4-way crossover model.

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: February 10, 2025
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (2)