Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment

NCT06535399 — Phase 1, Completed, 29 participants, Celgene

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A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

RegistryNCT06535399
StatusCompleted
PhasePhase 1
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment29 (Actual)
SponsorCelgene (Industry)
ConditionsHepatic Impairment, Healthy Volunteers
InterventionsBMS-986369 (Drug)
Datesstart 2024-08-15, primary completion 2025-11-12, completion 2025-11-12, first posted 2024-08-02, last updated 2026-01-23
Locations3 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Hepatic Impairment All trials for Healthy Volunteers All trials of BMS-986369

-Summary

The purpose of this study is to assess the drug levels and safety of golcadomide (BMS-986369) in adult participants with moderate and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.

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+Arms and interventions

ArmTypeInterventionsDescription
Group A: BMS-986369 Moderate Hepatic ImpairmentExperimentalDrug: BMS-986369
Group B: BMS-986369 Severe Hepatic ImpairmentExperimentalDrug: BMS-986369
Group C: BMS-986369 Normal Hepatic FunctionExperimentalDrug: BMS-986369
  • BMS-986369 (Drug), also known as Golcadomide: Specified dose on specified days

+Outcome measures

Primary outcomes

  • Maximum observed plasma concentration (Cmax) [Up to approximately 44 days]
  • Time of maximum observed plasma concentration (Tmax) [Up to approximately 44 days]
  • Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [Up to approximately 44 days]

Secondary outcomes

  • Incidence of adverse events (AEs) [Up to approximately 44 days]
  • Incidence of serious adverse events (SAEs) [Up to approximately 44 days]
  • Number of participants with physical examination abnormalities [Up to approximately 44 days]
  • Number of participants with vital sign abnormalities [Up to approximately 44 days]
  • Number of participants with electrocardiogram (ECG) abnormalities [Up to approximately 44 days]
  • Number of participants with clinical safety laboratory test abnormalities [Up to approximately 44 days]

+Eligibility

Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers

Inclusion Criteria for all Participants (Group A, Group B, Group C):

* Body mass index (BMI) between 18 and 40 kg/m\^2 (inclusive), and body weight ≥ 50 kg.

Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group A and Group B):

* Participants have moderate HI (Group A), severe HI (Group B) or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
* Participants have moderate (Group A) or severe (Group B) HI as defined by National Cancer Institute-Organ Dysfunction Working Group (NCI-ODWG) criteria.

Inclusion Criteria for a Matched Healthy Participant (Group C):

* Participants must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions as agreed by the investigator and the Sponsor Medical Monitor.
* Participants must be free of any clinically significant disease that would interfere with the study evaluations.

Exclusion Criteria for all Participants (Group A, Group B, and Group C):

* Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME).
* History of major surgery within 8 weeks before the study intervention administration.
* Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, as determined by the investigator.
* Other protocol-defined Inclusion/Exclusion criteria apply.

+Locations (3)

FacilityCityCountryStatus
Local Institution - 0001Chandler, ArizonaUnited States
Local Institution - 0002Orlando, FloridaUnited States
Texas Liver InstituteSan Antonio, TexasUnited States

+Investigators

  • Bristol-Myers Squibb, Study director, Bristol-Myers Squibb