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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05707390
Other study ID # CA057-1010
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 20, 2023
Est. completion date September 13, 2023

Study information

Verified date February 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date September 13, 2023
Est. primary completion date September 13, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mezigdomide
Specified dose on specified days

Locations

Country Name City State
United States PANAX Miami Lakes Florida
United States Orlando Clinical Research Center OCRC Orlando Florida
United States The Texas Liver Institute San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum observed concentration (Cmax) Up to 6 days
Primary Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T]) Up to 6 days
Primary Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) Up to 6 days
Secondary Number of participants with adverse events (AEs) Up to 6 days
Secondary Number of participants with serious adverse events (SAEs) Up to 6 days
Secondary Number of participants with physical examination abnormalities Up to 6 days
Secondary Number of participants with vital sign abnormalities Up to 6 days
Secondary Number of participants with electrocardiogram (ECG) abnormalities Up to 6 days
Secondary Number of participants with clinical laboratory abnormalities Up to 6 days
Secondary Metabolic ratio of AUC(0-T) Up to 6 days
Secondary Metabolic ratio of AUC(0-INF) Up to 6 days
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