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

NCT ID: NCT06318676

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-21

Study Completion Date

2024-11-15

Brief Summary

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

Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: Participants with severe renal impairment

Group Type EXPERIMENTAL

Mezigdomide

Intervention Type DRUG

Specified dose on specified days

Group B: Participants with End Stage Renal Disease

Group Type EXPERIMENTAL

Mezigdomide

Intervention Type DRUG

Specified dose on specified days

Group C: Participants with normal renal function

Group Type EXPERIMENTAL

Mezigdomide

Intervention Type DRUG

Specified dose on specified days

Interventions

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Mezigdomide

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986348 CC-92480

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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PANAX

Miami Lakes, Florida, United States

Site Status

Omega Research Group - Orlando

Orlando, Florida, United States

Site Status

Orlando Clinical Research Center OCRC

Orlando, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA057-1009

Identifier Type: -

Identifier Source: org_study_id

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