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Trial ID IM027-1014  |   NCT06723535

A Study to Evaluate BMS-986278 in Participants With Normal Renal Function, Severe Renal Impairment, or End-Stage Renal Disease on Intermittent Hemodialysis

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-84
    Age Range
  • 4
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to assess the effect of severe renal impairment (RI) and end-stage renal disease (ESRD) with intermittent hemodialysis (IHD) on the pharmacokinetics and safety of BMS-986278. This study plans to use a staged design based on RI severity.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Body mass index (BMI) between 18 and 45 kg/m2 inclusive, and body weight ≥ 50 kg at screening. Note: for ESRD participants, this body weight should be the prescription dry weight.
    1. Severe Renal Impaired Participants: 1. Participant has a supine SBP ≥ 90 and ≤ 180 mmHg, supine DBP ≥ 60 and ≤ 100 mmHg, and heart rate ≥ 40 and ≤ 110 beats per minute. 2. Participant has severe RI as defined by an eGFR ˂ 30 mL/min and not requiring dialysis at screening. 3. Participant must be medically stable for at least 1 month before study intervention administration.
      1. Participants with ESRD: 1. Participant has ESRD as defined by an eGFR < 15 mL/min at screening. 2. Participant required to be on intermittent hemodialysis, an average of 3 hemodialysis treatments per week prior to screening. 3. Participant has demonstrated adequate hemodialysis measurements (at least 2 Kt/V measurements ≥ 1.2 or 2 urea reduction ratio measurements ≥ 65%) within the 3 months prior to screening.
        1. Healthy participant should have a supine SBP ≥ 90 and ≤ 160 mm Hg, supine DBP ≥ 50 and ≤ 100 mm Hg, and heart rate ≥ 40 and ≤ 100 beats per minute.
          1. Healthy participants should have normal renal function, as defined by having an eGFR ≥ 90 mL/min eGFR at screening (calculated using the CKD-EPI equation).

            Exclusion Criteria

            Exclusion Criteria Icon
            :
            • Participant with any significant medical condition, laboratory abnormality, or psychiatric illness.
              1. Any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, or excretion (eg, bariatric procedure or cholecystectomy).
                1. Individuals who are of childbearing potential, breastfeeding, or currently pregnant.
                  1. Other protocol defined inclusion/exclusion criteria apply.
                    Additional Information *

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Group A and C

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986278

                    Study Arms

                    Experimental: Group B: Period 1

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986278

                    Study Arms

                    Experimental: Group B: Period 2

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986278
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