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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: Mezigdomide

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • PANAX
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center OCRC
  • Texas
    • San Antonio, Texas, United States, 78215
      • The Texas Liver Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild hepatic impairment	Drug: Mezigdomide; Specified dose on specified days; Other Names: BMS-986348; CC-92480
Experimental: Moderate hepatic impairment	Drug: Mezigdomide; Specified dose on specified days; Other Names: BMS-986348; CC-92480
Experimental: Severe hepatic impairment	Drug: Mezigdomide; Specified dose on specified days; Other Names: BMS-986348; CC-92480
Experimental: Healthy participants	Drug: Mezigdomide; Specified dose on specified days; Other Names: BMS-986348; CC-92480

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: CC-92480; BMS-986348; Mezigdomide
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: CA057-1010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No