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A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment - CA057-1010
Actualizada: 20 marzo, 2023 | ClinicalTrials.gov
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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
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