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
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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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2024-03-21
2024-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group A: Participants with severe renal impairment
Mezigdomide
Specified dose on specified days
Group B: Participants with End Stage Renal Disease
Mezigdomide
Specified dose on specified days
Group C: Participants with normal renal function
Mezigdomide
Specified dose on specified days
Interventions
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Mezigdomide
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
82 Years
ALL
Yes
Sponsors
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Celgene
INDUSTRY
Responsible Party
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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
Omega Research Group - Orlando
Orlando, Florida, United States
Orlando Clinical Research Center OCRC
Orlando, Florida, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA057-1009
Identifier Type: -
Identifier Source: org_study_id
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