A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
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.
Key facts
- Study ID
- NCT05707390
- Run by
- Bristol-Myers Squibb
- People needed
- 32
- Starts
- 2023-02-20
- Expected to finish
- 2023-09-13
- Last updated by the study team
- 2024-02-07
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- PANAX — Miami Lakes, Florida, United States
- Orlando Clinical Research Center OCRC — Orlando, Florida, United States
- The Texas Liver Institute — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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