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Trial ID CA073-1033  |   NCT07763418

A Study to Evaluate the Pharmacokinetics and Safety of Golcadomide in Participants With Severe Renal Impairment and End-Stage Renal Disease Compared With Participants With Normal Renal Function

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-84
    Age Range
  • 3
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to assess the pharmacokinetics and safety of golcadomide (BMS-986369) in matched healthy participants with normal renal function, adult participants with severe renal impairment, and participants with end-stage renal disease.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Participant must have severe renal impairment (RI).
    1. Participant must have end-stage renal disease (ESRD).
      1. Participant must be healthy male and female participants not of childbearing potential between 18 and 84 years of age (inclusive) with a BMI between 18 and 40 kg/m2, (inclusive) at screening.

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME).
          1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
            1. Known or suspected active autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
              1. Other protocol-defined inclusion/exclusion criteria apply.
                Additional Information *

                Treatment Options

                Study Arms

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: Group A

                ASSIGNED INTERVENTION
                • Drug: Golcadomide

                Study Arms

                Experimental: Group B

                ASSIGNED INTERVENTION
                • Drug: Golcadomide

                Study Arms

                Experimental: Group C

                ASSIGNED INTERVENTION
                • Drug: Golcadomide
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