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NCT Number: NCT07422298

A Study to Evaluate the Effect 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.

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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

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location status: Recruiting

Location contact

Alan Hand, Site 0001

CONTACT

210-635-1515

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 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.

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

    Time frame: Up to Day 13

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

    Time frame: Up to Day 13

Secondary outcomes

  1. Change from baseline heart rate (HR)

    Time frame: Up to Day 13

  2. Placebo-corrected change from baseline HR

    Time frame: Up to Day 13

  3. Change from baseline PR interval

    Time frame: Up to Day 13

  4. Placebo-corrected change from baseline PR interval

    Time frame: Up to Day 13

  5. Change from baseline QRS interval

    Time frame: Up to Day 13

  6. Placebo-corrected change from baseline QRS interval

    Time frame: Up to Day 13

  7. Number of participants with categorical outliers for QTcF

    Time frame: Up to Day 13

  8. Number of participants with categorical outliers for HR

    Time frame: Up to Day 13

  9. Number of participants with categorical outliers for PR interval

    Time frame: Up to Day 13

  10. Number of participants with categorical outliers for QRS interval

    Time frame: Up to Day 13

  11. Number of participants with treatment-emergent changes of electrocardiogram (ECG) morphology

    Time frame: Up to Day 13

  12. Change from baseline QTcF (ΔQTcF)

    Time frame: Up to Day 13

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

    Time frame: Up to Day 13

  14. Number of participants with non-serious adverse events (AEs)

    Time frame: Up to approximately 17 weeks

  15. Number of participants with Serious AEs (SAEs)

    Time frame: Up to approximately 17 weeks

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

    Time frame: Up to approximately 17 weeks

  17. Number of participants with vital sign abnormalities

    Time frame: Up to approximately 17 weeks

  18. Number of participants with clinical laboratory assessment abnormalities

    Time frame: Up to approximately 17 weeks

  19. Number of participants with 12-lead ECG abnormalities

    Time frame: Up to approximately 17 weeks

  20. Number of participants with physical examination abnormalities

    Time frame: Up to approximately 17 weeks

  21. Maximum observed concentration (Cmax)

    Time frame: Up to Day 13

  22. Time of maximum observed concentration (Tmax)

    Time frame: Up to Day 13

  23. Area under the concentration-time curve in 1 dosing interval (AUC[TAU])

    Time frame: Up to Day 13

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Mar 17, 2026

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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