Clinical trial NCT06535399: Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatic Impairment
Healthy Volunteers
Keywords: Healthy Volunteers
Pharmacokinetics
Liver Diseases
Moderate and Severe Hepatic Impairment
BMS-986369
CC-99282
Hepatic Impairment
Golcadomide
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2024-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to approximately 44 days
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to approximately 44 days
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
timeFrame: Up to approximately 44 days
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to approximately 44 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to approximately 44 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to approximately 44 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to approximately 44 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to approximately 44 days
measure: Number of participants with clinical safety laboratory test abnormalities
timeFrame: Up to approximately 44 days
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Liver Health
state: Arizona
city: Chandler
country: United States
facility: Local Institution - 0004
state: Arizona
city: Orlando
country: United States
facility: Local Institution - 0005
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: San Antonio
country: United States
facility: Local Institution - 0006
state: Texas
city: San Antonio
country: United States
facility: Texas Liver Institute
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: