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Completed

NCT Number: NCT06723535

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

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 information

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0002, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Severe Renal Impaired Participants:
  • Participant has a supine SBP ≥ 90 and ≤ 180 mmHg, supine DBP ≥ 60 and ≤ 100 mmHg, and heart rate ≥ 40 and ≤ 110 beats per minute.
  • Participant has severe RI as defined by an eGFR ˂ 30 mL/min and not requiring dialysis at screening.
  • Participant must be medically stable for at least 1 month before study intervention administration.
  • Participants with ESRD:
  • Participant has ESRD as defined by an eGFR < 15 mL/min at screening.
  • Participant required to be on intermittent hemodialysis, an average of 3 hemodialysis treatments per week prior to screening.
  • 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.
  • 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.
  • 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

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

Treatment and study plan

BMS-986278

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to Day 8

  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

    Time frame: Up to Day 8

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

    Time frame: Up to Day 8

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 28 days following discontinuation of dosing

  2. Number of participants with physical examination abnormalities

    Time frame: Up to Day 8

  3. Number of participants with vital sign abnormalities

    Time frame: Up to Day 8

  4. Number of participants with 12-lead electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 8

  5. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 8

  6. Time of maximum observed concentration (Tmax)

    Time frame: Up to Day 8

  7. Terminal elimination half-life (T-HALF)

    Time frame: Up to Day 8

  8. Apparent body clearance (CLT/F)

    Time frame: Up to Day 8

  9. Apparent volume of distribution of terminal phase (Vz/F)

    Time frame: Up to Day 8

  10. Concentration of BMS-986278 in dialysate

    Time frame: Up to Day 8

  11. Total amount recovered in dialysate (DR)

    Time frame: Up to Day 8

  12. Total percent of administered dose recovered in dialysate (%DR)

    Time frame: Up to Day 8

  13. Free fraction of unbound drug (Fu)

    Time frame: Up to Day 8

  14. Unbound Cmax (Cmax_u)

    Time frame: Up to Day 8

  15. Unbound AUC(0-T) (AUC(0-T) _u)

    Time frame: Up to Day 8

  16. Unbound AUC(INF) (AUC(INF)_u)

    Time frame: Up to Day 8

  17. Unbound CLT/F (CLT/F_u)

    Time frame: Up to Day 8

  18. Unbound Vz/F (Vz/F_u)

    Time frame: Up to Day 8

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-Label, Single-Dose, Phase 1 Study to Evaluate the Pharmacokinetics and Safety of BMS-986278 in Participants With Normal Renal Function, Participants With Severe Renal Impairment, and Participants With End-Stage Renal Disease on Intermittent Hemodialysis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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