A Study to Evaluate the Pharmacokinetics and Safety of Golcadomide in Participants With Severe Renal Impairment and End-Stage Renal Disease Compared With Participants With Normal Renal Function

August 10, 2026 updated by: Bristol-Myers Squibb

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Local Institution - 0003
        • Contact:
          • Site 0003
    • Florida
      • Miami Lakes, Florida, United States, 33014
        • Local Institution - 0002
        • Contact:
          • Site 0002
      • Orlando, Florida, United States, 32809-3017
        • Local Institution - 0001
        • Contact:
          • Site 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Drug: Golcadomide
Specified dose on specified days
Other Names:
  • BMS-986369
  • CC-99282
Experimental: Group B
Drug: Golcadomide
Specified dose on specified days
Other Names:
  • BMS-986369
  • CC-99282
Experimental: Group C
Drug: Golcadomide
Specified dose on specified days
Other Names:
  • BMS-986369
  • CC-99282

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration (Cmax)
Time Frame: Up to Day 44
Up to Day 44
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to Day 44
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
Up to Day 44
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time Frame: Up to Day 44
Up to Day 44

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to Day 60
Up to Day 60
Number of participants with serious adverse events (SAEs)
Time Frame: Up to Day 60
Up to Day 60
Number of participants with physical examination (PE) abnormalities
Time Frame: Up to Day 44
Up to Day 44
Number of participants with vital sign abnormalities
Time Frame: Up to Day 44
Up to Day 44
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to Day 44
Up to Day 44
Number of participants with clinical safety laboratory abnormalities
Time Frame: Up to Day 44
Up to Day 44
Dialysate clearance of golcadomide from plasma (CLD)
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 24, 2026

Primary Completion (Estimated)

December 14, 2026

Study Completion (Estimated)

December 28, 2026

Study Registration Dates

First Submitted

August 10, 2026

First Submitted That Met QC Criteria

August 10, 2026

First Posted (Actual)

August 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA073-1033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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