Evaluating BMS-986278 in patients with kidney issues
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
This study tests how a new drug called BMS-986278 works and its safety in people with different levels of kidney problems, including those on dialysis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 4 sites (Miami, Florida and 3 other locations) |
| Trial ID | NCT06723535 on ClinicalTrials.gov |
What this trial studies
This study assesses the pharmacokinetics and safety of BMS-986278 in participants with varying degrees of renal impairment, including severe renal impairment and end-stage renal disease on intermittent hemodialysis. The study employs a staged design based on the severity of renal impairment to evaluate how these conditions affect the drug's behavior in the body. Participants will be monitored for safety and efficacy throughout the study.
Who should consider this trial
Good fit: Ideal candidates include adults with severe renal impairment or end-stage renal disease who are stable and meet specific health criteria.
Not a fit: Patients with renal function that does not fall into the severe impairment or end-stage categories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with severe renal impairment and end-stage renal disease.
How similar studies have performed: Other studies have explored pharmacokinetics in renal impairment, but the specific approach of this study may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Miami, Florida and 3 other locations
- Clinical Pharmacology Of Miami, LLC — Miami, Florida, United States (Recruiting)
- Advanced Pharma CR, LLC — Miami, Florida, United States (Recruiting)
- Omega Research Group, LLC - Orlando — Orlando, Florida, United States (Recruiting)
- Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 8559073286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.