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Trial ID IM027-1012  |   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

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-55
    Age Range
  • 2
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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 Eligibility Criteria

Inclusion Criteria

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

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Any significant acute or chronic medical illness as determined by the investigator.
          1. 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.
            1. 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.
              1. Other protocol-defined inclusion/exclusion criteria apply.
                Additional Information *

                Treatment Options

                Study Arms

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: Part A

                ASSIGNED INTERVENTION
                • Drug: BMS-986278, Placebo

                Study Arms

                Experimental: Part B1/B2 Treatment A

                ASSIGNED INTERVENTION
                • Drug: BMS-986278

                Study Arms

                Experimental: Part B1/B2 Treatment B

                ASSIGNED INTERVENTION
                • Drug: BMS-986278, Placebo

                Study Arms

                Experimental: Part B1/B2 Treatment C

                ASSIGNED INTERVENTION
                • Drug: Placebo

                Study Arms

                Experimental: Part B1/B2 Treatment D

                ASSIGNED INTERVENTION
                • Drug: Placebo, Moxifloxacin

                Study Arms

                Experimental: Part B3 Treatment A

                ASSIGNED INTERVENTION
                • Drug: BMS-986278

                Study Arms

                Experimental: Part B3 Treatment B

                ASSIGNED INTERVENTION
                • Drug: BMS-986278, Placebo

                Study Arms

                Experimental: Part B3 Treatment C

                ASSIGNED INTERVENTION
                • Drug: Placebo

                Study Arms

                Experimental: Part B3 Treatment D

                ASSIGNED INTERVENTION
                • Drug: Placebo, Moxifloxacin
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