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NCT Number: NCT07763418

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

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.

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0003, Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

golcadomide

Drug

Specified dose on specified days

Other names: BMS-986369, CC-99282

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to Day 44

  2. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to Day 44

  3. 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

  4. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to Day 44

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to Day 60

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to Day 60

  3. Number of participants with physical examination (PE) abnormalities

    Time frame: Up to Day 44

  4. Number of participants with vital sign abnormalities

    Time frame: Up to Day 44

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 44

  6. Number of participants with clinical safety laboratory abnormalities

    Time frame: Up to Day 44

  7. Dialysate clearance of golcadomide from plasma (CLD)

    Time frame: Day 1

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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