Go back to trials list
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)
Interventions
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
Interested in joining this trial?
Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.
Get the latest thought leadership on your Kidney Disease delivered straight to your inbox
Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.