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NCT05707390
A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
Conditions: Hepatic Impairment
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 48
Sponsor: Bristol-Myers Squibb
Location: United States
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05707390). StuddyBuddy aggregates publicly available trial information.