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

Phase 1

Recruiting

• Conditions: Kidney Failure, Chronic; Healthy Volunteers; Renal Impairment
• Interventions: Drug: BMS-986278

• Registration Number: NCT06723535
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Study Start: 2024-12-07
• Study First Posted: 2024-12-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-10-17
• Study Completion: 2025-10-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A and C	BMS-986278	-
Group B: Period 1	BMS-986278	-
Group B: Period 2	BMS-986278	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Clinical Pharmacology Of Miami, LLC; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Advanced Pharma CR, LLC; 🇺🇸 Miami, Florida, United States

Omega Research Group, LLC - Orlando; 🇺🇸 Orlando, Florida, United States