Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Pa… (NCT06535399) | Clinical Trial Compass
CompletedPhase 1
Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
United States29 participantsStarted 2024-08-15
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
Maximum observed plasma concentration (Cmax)
Timeframe: Up to approximately 44 days
2
Time of maximum observed plasma concentration (Tmax)
Timeframe: Up to approximately 44 days
3
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]