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Trial ID CN014-0001  |   NCT07283263

A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.

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Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-80
    Age Range
  • 1
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.

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Key Eligibility Criteria

Inclusion Criteria

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:
  • Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests.
    1. Participants must have a body mass index (BMI) between 18 and 32 kg/m² (inclusive) and body weight of at least 50 kg.
      1. For Part B/Cohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator.

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Participants must not have any significant medical condition or history (renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic) that may affect drug absorption, distribution, metabolism, or excretion (ADME), or pose a risk to the participant.
          1. Participants must not have a history of rhabdomyolysis, cancer (except certain cured skin or cervical cancers), hematologic malignancy, or myelodysplastic syndrome.
            1. Participants must not have recent or current significant GI disease, major surgery, or medical interventions affecting ADME (except appendectomy or cholecystectomy).
              1. Participants must not have had a blood transfusion within 4 weeks or have an inability to tolerate oral medication or venous access.
                1. Other protocol defined inclusion/exclusion criteria apply.
                  Additional Information *

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part A Cohort 1

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part A Cohort 2

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part A Cohort 3

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part A Cohort 4

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part A Cohort 5

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part A Cohort 6

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part B Cohort 10

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part B Cohort 11

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part B Cohort 7

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part B Cohort 8

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part B Cohort 9

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part C

                  ASSIGNED INTERVENTION
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