CClinicalTrials.gg
Sign In
Not yet recruitingNCT07763418Updated Aug 13, 2026

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

A Phase 1 interventional study of Golcadomide in Kidney Failure, Chronic, sponsored by Bristol-Myers Squibb. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years to 84 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 84 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Kidney Failure, Chronic

Keywords

  • Golcadomide
03

Who can participate

Ages eligible
18 Years to 84 Years
Sexes eligible
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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Group A

    Drug: Golcadomide

  • Experimental
    Group B

    Drug: Golcadomide

  • Experimental
    Group C

    Drug: Golcadomide

Interventions

  • DrugGolcadomide

    Specified dose on specified days

    Also known as: BMS-986369, CC-99282

05

What researchers measure

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

06

Study locations

3 sites
  • Local Institution - 0003
    Chandler, Arizona 85225, United States
    • Site 0003 · Contact
  • Local Institution - 0002
    Miami Lakes, Florida 33014, United States
    • Site 0002 · Contact
  • Local Institution - 0001
    Orlando, Florida 32809-3017, United States
    • Site 0001 · Contact
07

References and documents

Individual participant data

Plan to share: Yes — 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

Supporting information: Study protocol, Sap, Csr

08

Registry details

Key details

Study ID
NCT07763418
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Aug 13, 2026
Start date
Aug 24, 2026 (estimated)
Primary completion
Dec 14, 2026 (estimated)
Completion
Dec 28, 2026 (estimated)
Last update
Aug 13, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Kidney Failure, Chronic→

Other studies from this sponsor

Bristol-Myers Squibb

Start the discussion