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NCT05707390 | Completed | Hepatic Impairment

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

Bristol-Myers Squibb

Brief 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.

Condition or disease

Hepatic Impairment

Intervention/treatment

Mezigdomide

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 32 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : 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
Actual Study Start Date : February 20, 2023
Estimated Primary Completion Date : September 13, 2023
Estimated Study Completion Date : September 13, 2023
Arm Intervention/treatment

Experimental: Mild hepatic impairment

Drug: Mezigdomide

Experimental: Moderate hepatic impairment

Drug: Mezigdomide

Experimental: Severe hepatic impairment

Drug: Mezigdomide

Experimental: Healthy participants

Drug: Mezigdomide
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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) 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
A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment

Location Details

Please Choose a site

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Florida

PANAX

Miami Lakes, florida, United States, 33014

Not yet recruiting

United States, Florida

Orlando Clinical Research Center OCRC

Orlando, florida, United States, 32809

Not yet recruiting

United States, Texas

The Texas Liver Institute

Saint Anthony, Texas, United States, 78215