Clinical trial NCT05707390: A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Mezigdomide
BMS-986348
CC-92480
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-01-31
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to 6 days
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])
timeFrame: Up to 6 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
timeFrame: Up to 6 days
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 6 days
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 6 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 6 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 6 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 6 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 6 days
measure: Metabolic ratio of AUC(0-T)
timeFrame: Up to 6 days
measure: Metabolic ratio of AUC(0-INF)
timeFrame: Up to 6 days
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: PANAX
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center OCRC
state: Florida
city: San Antonio
country: United States
facility: The Texas Liver Institute
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: