Recruiting
Phase 1

Golcadomide

Sponsor:

Bristol-Myers Squibb

Code:

NCT07763418

Conditions

Kidney Failure, Chronic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Golcadomide

Study Details

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

Study ID

NCT07763418

Start date

Sep 8, 2026

Status verified date

Sep, 2026

Completion date

Dec 28, 2026

Anticipated

Primary completion date

Dec 14, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A

experimental: Group B

experimental: Group C

Interventions

Golcadomide

Specified dose on specified days

Primary outcome measure

  • 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 ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [ Time Frame: Up to Day 44 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Arizona Clinical Trials - Chandler

Recruiting

Chandler, Arizona, United States, 85225

Contacts

Anita Kohli, Site 0003

434-825-0921

Panax Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Robert Perry, Site 0002

305-698-4500

Orlando Clinical Research Center OCRC

Recruiting

Orlando, Florida, United States, 32809-3017

Contacts

Thomas Marbury, Site 0001

407-257-3462

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • Golcadomide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.