RECRUITING

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

Description

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.

Study Overview

Study Details

Study 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.

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

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

Condition
Kidney Failure, Chronic
Intervention / Treatment

-

Contacts and Locations

Miami

Local Institution - 0003, Miami, Florida, United States, 33014-3616

Miami

Advanced Pharma CR, LLC, Miami, Florida, United States, 33147-4040

Orlando

Omega Research Group, LLC - Orlando, Orlando, Florida, United States, 32808-7820

Orlando

Orlando Clinical Research Center, Orlando, Florida, United States, 32809-3017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 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.
  • * 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.
  • * 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).
  • * 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.

Ages Eligible for Study

18 Years to 84 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2025-10-17