A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
NCT ID: NCT05707390
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2023-02-20
2023-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mild hepatic impairment
Mezigdomide
Specified dose on specified days
Moderate hepatic impairment
Mezigdomide
Specified dose on specified days
Severe hepatic impairment
Mezigdomide
Specified dose on specified days
Healthy participants
Mezigdomide
Specified dose on specified days
Interventions
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Mezigdomide
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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PANAX
Miami Lakes, Florida, United States
Orlando Clinical Research Center OCRC
Orlando, Florida, United States
The Texas Liver Institute
San Antonio, Texas, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA057-1010
Identifier Type: -
Identifier Source: org_study_id
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