| Trial ID: | L1227 |
| Source ID: | NCT06723535
|
| Associated Drug: |
Bms-986278
|
| Title: |
A Study to Evaluate BMS-986278 in Participants With Normal Renal Function, Severe Renal Impairment, or End-Stage Renal Disease on Intermittent Hemodialysis
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Failure, Chronic|Healthy Volunteers|Renal Impairment
|
| Interventions: |
DRUG: BMS-986278
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-12-07
|
| Completion Date: |
2025-10-17
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-13
|
| Locations: |
Clinical Pharmacology Of Miami, LLC, Miami, Florida, 33014-3616, United States|Advanced Pharma CR, LLC, Miami, Florida, 33147-4040, United States|Omega Research Group, LLC - Orlando, Orlando, Florida, 32808-7820, United States|Orlando Clinical Research Center, Orlando, Florida, 32809-3017, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06723535
|
