A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
- Registration Number
- NCT05707390
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Hepatic Impaired Participants:
- Participants have mild, moderate, or severe hepatic impairment or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
- Participants have mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment as defined by Child-Pugh Score.
Matched Healthy Participants:
- Participant must be free of any clinically significant disease that would interfere with the study evaluations.
- Participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator.
Exclusion Criteria
All Participants:
- History of chronic pruritus or dermatologic syndromes that may be confounded with reactions to mezigdomide.
- Contraindication or intolerance to first-generation antihistamine medications.
Hepatic Impaired Participants:
-Clinical laboratory test results:
- Platelet count lower than 30,000/microliter (μL) at screening or Day -1.
- Absolute neutrophil counts lower than 1,500/μL at screening or Day -1.
Matched Healthy Participants:
-History of or suspected benign ethnic neutropenia.
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy participants Mezigdomide - Mild hepatic impairment Mezigdomide - Moderate hepatic impairment Mezigdomide - Severe hepatic impairment Mezigdomide -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T]) Up to 6 days Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) Up to 6 days Maximum observed concentration (Cmax) Up to 6 days
- Secondary Outcome Measures
Name Time Method Number of participants with vital sign abnormalities Up to 6 days Number of participants with serious adverse events (SAEs) Up to 6 days Metabolic ratio of AUC(0-T) Up to 6 days Number of participants with adverse events (AEs) Up to 6 days Number of participants with electrocardiogram (ECG) abnormalities Up to 6 days Number of participants with physical examination abnormalities Up to 6 days Number of participants with clinical laboratory abnormalities Up to 6 days Metabolic ratio of AUC(0-INF) Up to 6 days
Trial Locations
- Locations (3)
Orlando Clinical Research Center OCRC
🇺🇸Orlando, Florida, United States
The Texas Liver Institute
🇺🇸San Antonio, Texas, United States
PANAX
🇺🇸Miami Lakes, Florida, United States