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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


Description

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

Trial Eligibility

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 Info

Organization

Celgene


Primary Outcome

Maximum observed concentration (Cmax)


Outcome Timeframe Up to 24 days

NCTID NCT06318676

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2024-03-21

Completion Date 2025-03-05

Enrollment Target 32

Interventions

DRUG Mezigdomide

Locations Recruiting

PANAX

United States, Florida, Miami Lakes


Omega Research Group - Orlando

United States, Florida, Orlando


Orlando Clinical Research Center OCRC

United States, Florida, Orlando


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