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

NCT05707390 | Completed Phase 1 FDA Drug

• 1 other identifier: CA057-1010
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatic Impairment

Keywords

Mezigdomide; BMS-986348; CC-92480

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (4)

Mild hepatic impairment

EXPERIMENTAL

Drug: Mezigdomide

Moderate hepatic impairment

EXPERIMENTAL

Drug: Mezigdomide

Severe hepatic impairment

EXPERIMENTAL

Drug: Mezigdomide

Healthy participants

EXPERIMENTAL

Drug: Mezigdomide

Interventions

Mezigdomide DRUG

Specified dose on specified days

Also known as: BMS-986348, CC-92480

Healthy participants; Mild hepatic impairment; Moderate hepatic impairment; Severe hepatic impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

PANAX

Miami Lakes, Florida, 33014, United States

Location

Orlando Clinical Research Center OCRC

Orlando, Florida, 32809, United States

Location

The Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: January 31, 2023
• Study Start: February 20, 2023
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)