A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment
Completed · Phase 1
Conditions studied: Renal Impairment
In brief
The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.
Key facts
- Study ID
- NCT06318676
- Run by
- Celgene
- People needed
- 26
- Starts
- 2024-03-21
- Expected to finish
- 2024-11-15
- Last updated by the study team
- 2025-06-04
Who can join
Age: 18 and older, up to 82. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- PANAX — Miami Lakes, Florida, United States
- Omega Research Group - Orlando — Orlando, Florida, United States
- Orlando Clinical Research Center OCRC — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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