Back to resultsA Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
Primary Purpose
Hepatic Impairment
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mezigdomide
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment focused on measuring Mezigdomide, BMS-986348, CC-92480
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
Sites / Locations
- PANAXRecruiting
- Orlando Clinical Research Center OCRCRecruiting
- The Texas Liver InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Mild hepatic impairment
Moderate hepatic impairment
Severe hepatic impairment
Healthy participants
Arm Description
Outcomes
Primary Outcome Measures
Maximum observed concentration (Cmax)
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Secondary Outcome Measures
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Number of participants with physical examination abnormalities
Number of participants with vital sign abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with clinical laboratory abnormalities
Metabolic ratio of AUC(0-T)
Metabolic ratio of AUC(0-INF)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05707390
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
November 27, 2023 (Anticipated)
Study Completion Date
November 27, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
Keywords
Mezigdomide, BMS-986348, CC-92480
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mild hepatic impairment
Arm Type
Experimental
Arm Title
Moderate hepatic impairment
Arm Type
Experimental
Arm Title
Severe hepatic impairment
Arm Type
Experimental
Arm Title
Healthy participants
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mezigdomide
Other Intervention Name(s)
BMS-986348, CC-92480
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Maximum observed concentration (Cmax)
Time Frame
Up to 6 days
Title
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
Title
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time Frame
Up to 6 days
Secondary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Time Frame
Up to 6 days
Title
Number of participants with serious adverse events (SAEs)
Time Frame
Up to 6 days
Title
Number of participants with physical examination abnormalities
Time Frame
Up to 6 days
Title
Number of participants with vital sign abnormalities
Time Frame
Up to 6 days
Title
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame
Up to 6 days
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to 6 days
Title
Metabolic ratio of AUC(0-T)
Time Frame
Up to 6 days
Title
Metabolic ratio of AUC(0-INF)
Time Frame
Up to 6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
PANAX
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Perry, Site 0002
Phone
3056984500107
Facility Name
Orlando Clinical Research Center OCRC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Marbury, Site 0001
Phone
407-257-3462
Facility Name
The Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Lawitz, Site 0003
Phone
210-253-3426
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
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