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

NCT07763418 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CA073-1033
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Kidney Failure, Chronic

Keywords

Golcadomide

Outcome Measures

Primary Outcomes (4)

• Maximum observed concentration (Cmax)

  Up to Day 44

• Time of maximum observed plasma concentration (Tmax)

  Up to Day 44

• Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

  Up to Day 44

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

  Up to Day 44

Secondary Outcomes (7)

• 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

Study Arms (3)

Group A

EXPERIMENTAL

Drug: Golcadomide

Group B

EXPERIMENTAL

Drug: Golcadomide

Group C

EXPERIMENTAL

Drug: Golcadomide

Interventions

Golcadomide DRUG

Specified dose on specified days

Also known as: BMS-986369, CC-99282

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Local Institution - 0003

Chandler, Arizona, 85225, United States

Location

Local Institution - 0002

Miami Lakes, Florida, 33014, United States

Location

Local Institution - 0001

Orlando, Florida, 32809-3017, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): August 24, 2026
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (3)