A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Mezigdomide in Healthy Participants and Those With Mild, Moderate, and Severe Hepatic Impairment
Sponsor: Bristol-Myers Squibb
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Maximum observed concentration (Cmax)
Time frame: Up to 6 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])
Time frame: Up to 6 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to 6 days
Secondary Endpoints
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Number of participants with physical examination abnormalities
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) a…
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