Healthy Volunteers, Hepatic Impairment
Conditions
Keywords
Healthy Volunteers, Pharmacokinetics, Liver Diseases, Moderate and Severe Hepatic Impairment, BMS-986369, CC-99282, Hepatic Impairment, Golcadomide
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.
Interventions
DRUGBMS-986369
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed