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

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

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

• Status: Completed
• Conditions: Kidney Failure, Chronic; Renal Impairment; Healthy Volunteers
• Intervention / Treatment: Drug: BMS-986278

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33147-4040
      • Local Institution - 0002
    • Miami, Florida, United States, 33172
      • Local Institution - 0003
    • Orlando, Florida, United States, 32809-3017
      • Orlando Clinical Research Center
    • Orlando, Florida, United States, 32808-7820
      • Local Institution - 0004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

  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).

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A and C	Drug: BMS-986278; Specified dose on specified days
Experimental: Group B: Period 1	Drug: BMS-986278; Specified dose on specified days
Experimental: Group B: Period 2	Drug: BMS-986278; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration (Cmax)	Up to Day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]	Up to Day 8
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]	Up to Day 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events (AEs)	Up to 28 days following discontinuation of dosing
Number of participants with physical examination abnormalities	Up to Day 8
Number of participants with vital sign abnormalities	Up to Day 8
Number of participants with 12-lead electrocardiogram (ECG) abnormalities	Up to Day 8
Number of participants with clinical laboratory abnormalities	Up to Day 8
Time of maximum observed concentration (Tmax)	Up to Day 8
Terminal elimination half-life (T-HALF)	Up to Day 8
Apparent body clearance (CLT/F)	Up to Day 8
Apparent volume of distribution of terminal phase (Vz/F)	Up to Day 8
Concentration of BMS-986278 in dialysate	Up to Day 8
Total amount recovered in dialysate (DR)	Up to Day 8
Total percent of administered dose recovered in dialysate (%DR)	Up to Day 8
Free fraction of unbound drug (Fu)	Up to Day 8
Unbound Cmax (Cmax_u)	Up to Day 8
Unbound AUC(0-T) (AUC(0-T) _u)	Up to Day 8
Unbound AUC(INF) (AUC(INF)_u)	Up to Day 8
Unbound CLT/F (CLT/F_u)	Up to Day 8
Unbound Vz/F (Vz/F_u)	Up to Day 8

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2024
• Primary Completion (Actual): September 16, 2025
• Study Completion (Actual): September 19, 2025

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Failure, Chronic
• Other Study ID Numbers: IM027-1014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No