A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: Mezigdomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild hepatic impairment<br> | Drug: Mezigdomide<br>* Specified dose on specified days<br>* Other names: CC-92480;|
| Experimental: Moderate hepatic impairment<br> | Drug: Mezigdomide<br>* Specified dose on specified days<br>* Other names: CC-92480;|
| Experimental: Severe hepatic impairment<br> | Drug: Mezigdomide<br>* Specified dose on specified days<br>* Other names: CC-92480;|
| Experimental: Healthy participants<br> | Drug: Mezigdomide<br>* Specified dose on specified days<br>* Other names: CC-92480;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) |  | Up to 6 days | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 6 days | 
| Number of participants with serious adverse events (SAEs) |  | Up to 6 days | 
| Number of participants with physical examination abnormalities |  | Up to 6 days | 
| Number of participants with vital sign abnormalities |  | Up to 6 days | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 6 days | 
| Number of participants with clinical laboratory abnormalities |  | Up to 6 days | 
| Metabolic ratio of AUC(0-T) |  | Up to 6 days | 
| Metabolic ratio of AUC(0-INF) |  | Up to 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986348, CC-92480, Mezigdomide