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Completed

NCT Number: NCT05707390

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PANAX, Miami Lakes, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mezigdomide

Drug

Specified dose on specified days

Other names: BMS-986348, CC-92480

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to 6 days

  2. 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

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])

    Time frame: Up to 6 days

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 6 days

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 6 days

  3. Number of participants with physical examination abnormalities

    Time frame: Up to 6 days

  4. Number of participants with vital sign abnormalities

    Time frame: Up to 6 days

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 6 days

  6. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 6 days

  7. Metabolic ratio of AUC(0-T)

    Time frame: Up to 6 days

  8. Metabolic ratio of AUC(0-INF)

    Time frame: Up to 6 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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