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

NCT06723535 | Completed Phase 1 FDA Drug

• 1 other identifier: IM027-1014
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

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.

Conditions

Kidney Failure, Chronic; Healthy Volunteers; Renal Impairment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (18)

• 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

Study Arms (3)

Group A and C

EXPERIMENTAL

Drug: BMS-986278

Group B: Period 1

EXPERIMENTAL

Drug: BMS-986278

Group B: Period 2

EXPERIMENTAL

Drug: BMS-986278

Interventions

BMS-986278 DRUG

Specified dose on specified days

Group A and C; Group B: Period 1; Group B: Period 2

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (4)

Local Institution - 0002

Miami, Florida, 33147-4040, United States

Location

Local Institution - 0003

Miami, Florida, 33172, United States

Location

Local Institution - 0004

Orlando, Florida, 32808-7820, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809-3017, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: December 7, 2024
• Primary Completion: September 16, 2025
• Study Completion: September 19, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (4)