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Trial ID CA125-1018  |   NCT06877702

A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants

Summary

  • Phase 1
  • Male Gender icon
  • 18-60
    Age Range
  • 1
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to assess the safety, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, echocardiogram or clinical laboratory assessments, as determined by the investigator.
    1. Participants must have a Body mass index (BMI) between 18.0 and 35.0 kilograms/meter square (kg/m2), inclusive.
      1. Male participants who are sexually active with individuals of childbearing potential (IOCBP) must agree to follow instructions for methods of contraception.

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Participants with prior exposure to BMS-986460 or with a prior history of heart failure, ischemic heart diseases, clinically significant cardiac arrythmias, or long QT syndrome are excluded.
          1. Participants with left ventricular ejection fraction (≤ 50%) at screening are excluded.
            1. Participants with history of anaphylactic reactions are excluded.
              1. Participants with current or recent (within 3 months of intervention administration) gastrointestinal disease that, in the opinion of the investigator, could affect the absorption of study intervention are excluded.
                1. Participants with history of Gilbert's syndrome are excluded.
                  Additional Information *
                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Part 1: Sequence 1

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986460

                    Study Arms

                    Experimental: Part 1: Sequence 2

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986460

                    Study Arms

                    Experimental: Part 1: Sequence 3

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986460

                    Study Arms

                    Experimental: Part 2: Optional Treatment C

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986460

                    Study Arms

                    Experimental: Part 2: Optional Treatment D

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986460

                    Study Arms

                    Experimental: Part 2: Optional Treatment E

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986460

                    Study Arms

                    Experimental: Part 2: Treatment A

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986460

                    Study Arms

                    Experimental: Part 2: Treatment B

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986460
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