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Completed

NCT Number: NCT06746402

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON San Antonio, San Antonio, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986278

Drug

Specified dose on specified days

Placebo

Drug

Specified dose on specified days

moxifloxacin

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with non-serious Adverse Events (AEs)

    Time frame: Until 28 days post last treatment dose

    Part A

  2. Number of participants with Serious AEs (SAEs)

    Time frame: Until 28 days post last treatment dose

    Part A

  3. Number of participants with AEs leading to study intervention discontinuation

    Time frame: Until 28 days post last treatment dose

    Part A

  4. Number of participants with vital sign abnormalities

    Time frame: Up to Day 18

    Part A

  5. Number of participants with clinical laboratory assessment abnormalities

    Time frame: Up to Day 18

    Part A

  6. Number of participants with 12-lead electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 18

    Part A

  7. Number of participants with physical examination abnormalities

    Time frame: Up to Day 18

    Part A

  8. Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)

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

    Part B

  9. Placebo-corrected change from baseline QTcF (ΔΔQTcF)

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

    Part B

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

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

    Part A and Part B

  2. Time of maximum observed plasma concentration (Tmax)

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

    Part A and Part B

  3. Area under the plasma concentration-time curve from time zero to the end of dosing interval AUC(TAU)

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

    Part A and Part B

  4. Terminal half-life (T-HALF)

    Time frame: Up to Day 18

    Part A

  5. Apparent total body clearance (CLT/F)

    Time frame: Up to Day 18

    Part A

  6. Change from baseline heart rate (HR) (∆HR)

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

    Part B

  7. Change from baseline PR interval (∆PR)

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

    Part B

  8. Change from baseline QRS interval (∆QRS)

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

    Part B

  9. Placebo-corrected change from baseline HR (ΔΔHR)

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

    Part B

  10. Placebo-corrected Change from baseline PR interval (ΔΔPR)

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

    Part B

  11. Placebo-corrected change from baseline QRS interval (ΔΔQRS)

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

    Part B

  12. Number of participants with categorical outliers for QTcF

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

    Part B

  13. Number of participants with categorical outliers for HR

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

    Part B

  14. Number of participants with categorical outliers for PR interval

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

    Part B

  15. Number of participants with categorical outliers for QRS interval

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

    Part B

  16. Number of participants with treatment-emergent changes of ECG morphology

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

    Part B

  17. ΔQTcF for moxifloxacin

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

    Part B

  18. ΔΔQTcF for moxifloxacin

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

    Part B

  19. Number of participants with non-serious AEs

    Time frame: Until 28 days post last treatment dose

    Part B

  20. Number of participants with SAEs

    Time frame: Until 28 days post last treatment dose

    Part B

  21. Number of participants with AEs leading to study intervention discontinuation

    Time frame: Until 28 days post last treatment dose

    Part B

  22. Number of participants with vital sign abnormalities

    Time frame: Up to Day 18 of Period 4 (Each period is 17 days)

    Part B

  23. Number of participants with clinical laboratory assessment abnormalities

    Time frame: Up to Day 17 of Period 4 (Each period is 17 days)

    Part B

  24. Number of participants with 12-lead ECG abnormalitie

    Time frame: Up to Day 17 of Period 4 (Each period is 17 days)

    Part B

  25. Number of participants with physical examination abnormalities

    Time frame: Up to Day 18 of Period 4 (Each period is 17 days)

    Part B

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2024
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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