A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment

March 12, 2024 updated by: Celgene

A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics of Mezigdomide (BMS-986348, CC-92480) in Adult Participants With Normal Renal Function, Severe Renal Impairment, and End-stage Renal Disease

The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT# and Site#

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami Lakes, Florida, United States, 33014
        • PANAX
        • Contact:
          • Robert Perry, Site 0002
          • Phone Number: 3056984500107
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center OCRC
        • Contact:
          • Thomas Marbury, Site 0001
          • Phone Number: 407-257-3462
      • Orlando, Florida, United States, 32808
        • Local Institution - 0003
        • Contact:
          • Site 0003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • Participants must have a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 40.0 kg/m2 inclusive at screening.
  • Participants must have a body weight ≥ 50 kg at screening.
  • Participants must be afebrile (febrile is defined as ≥ 38°C or 100.4°F) at screening, check in, and predose.

Exclusion Criteria

  • Participants must not have any history of chronic pruritus or dermatologic syndromes that may be confounded with reactions to mezigdomide.
  • Participants must not have any history of malignancy of any type other than in situ cervical cancer or surgically excised non-melanomatous skin cancers.
  • Participants with an inability to tolerate oral medication.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Participants with severe renal impairment
Drug: Mezigdomide
Specified dose on specified days
Other Names:
  • BMS-986348
  • CC-92480
Experimental: Group B: Participants with End Stage Renal Disease
Drug: Mezigdomide
Specified dose on specified days
Other Names:
  • BMS-986348
  • CC-92480
Experimental: Group C: Participants with normal renal function
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)
Time Frame: Up to 24 days
Up to 24 days
Area under the plasma concentration-time curve (AUC)
Time Frame: Up to 24 days
Up to 24 days
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T))
Time Frame: Up to 24 days
Up to 24 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration (Cmax)
Time Frame: Up to 24 days
Up to 24 days
Area under the plasma concentration-time curve (AUC)
Time Frame: Up to 24 days
Up to 24 days
Number of participants with adverse events (AEs)
Time Frame: Up to 54 days
Up to 54 days
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 54 days
Up to 54 days
Number of participants with physical examination findings
Time Frame: Up to 24 days
Up to 24 days
Number of participants with vital sign abnormalities
Time Frame: Up to 24 days
Up to 24 days
Number of participants with 12-lead electrocardiogram (ECG) findings
Time Frame: Up to 24 days
Up to 24 days
Time of maximum observed concentration (Tmax)
Time Frame: Up to 24 days
Up to 24 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

March 5, 2025

Study Completion (Estimated)

March 5, 2025

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA057-1009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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 Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

IPD Sharing Time Frame

See plan description

IPD Sharing Access Criteria

See plan description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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