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

Hepatic Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05707390
• Other study ID #: CA057-1010
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting