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: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 84
Healthy Volunteers: t
View:

• 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).

Locations
United States
Florida
Advanced Pharma CR, LLC
RECRUITING
Miami
Local Institution - 0003
NOT_YET_RECRUITING
Miami
Omega Research Group, LLC - Orlando
RECRUITING
Orlando
Orlando Clinical Research Center
RECRUITING
Orlando
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
8559073286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2024-12-07
Estimated Completion Date: 2025-10-17
Participants
Target number of participants: 32
Treatments
Experimental: Group A and C
Experimental: Group B: Period 1
Experimental: Group B: Period 2
Sponsors
Leads: Bristol-Myers Squibb

This content was sourced from clinicaltrials.gov

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