NCT07763418Not yet recruitingPhase 1
A Phase 1, Multi-center, Single-dose, Open-label Study to Evaluate the Pharmacokinetics and Safety of Golcadomide (BMS-986369) in Participants With Severe Renal Impairment and End-Stage Renal Disease Compared With Participants With Normal Renal Function
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Study Overview
Brief Summary
The purpose of this study is to assess the pharmacokinetics and safety of golcadomide (BMS-986369) in matched healthy participants with normal renal function, adult participants with severe renal impairment, and participants with end-stage renal disease.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 84 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participant must have severe renal impairment (RI).
- •Participant must have end-stage renal disease (ESRD).
- •Participant must be healthy male and female participants not of childbearing potential between 18 and 84 years of age (inclusive) with a BMI between 18 and 40 kg/m2, (inclusive) at screening.
Exclusion Criteria
- •Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME).
- •Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
- •Known or suspected active autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- •Other protocol-defined inclusion/exclusion criteria apply.
Arms & Interventions
Group A
Experimental
Intervention: Golcadomide (Drug)
Group B
Experimental
Intervention: Golcadomide (Drug)
Group C
Experimental
Intervention: Golcadomide (Drug)
Outcomes
Primary Outcomes
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time Frame: Up to Day 44
Maximum observed concentration (Cmax)
Time Frame: Up to Day 44
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to Day 44
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time Frame: Up to Day 44
Secondary Outcomes
- Number of participants with adverse events (AEs)(Up to Day 60)
- Number of participants with serious adverse events (SAEs)(Up to Day 60)
- Number of participants with physical examination (PE) abnormalities(Up to Day 44)
- Number of participants with vital sign abnormalities(Up to Day 44)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 44)
- Number of participants with clinical safety laboratory abnormalities(Up to Day 44)
- Dialysate clearance of golcadomide from plasma (CLD)(Day 1)
Investigators
Study Sites (3)
Loading locations...
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