NCT06723535

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	BMS-986278	Specified dose on specified days

Timeline

• Start date: 2024-12-07
• Primary completion: 2025-09-16
• Completion: 2025-09-19
• First posted: 2024-12-09
• Last updated: 2025-10-14

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study