A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment
Part of paid clinical trials in Miami Lakes, Florida.
- Sponsor
- Celgene
- Study ID
- NCT06318676
- Phase
- PHASE1
- Status
- Completed
Conditions
- Renal Impairment
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 82 Years
- Healthy Volunteers
- Accepted
Interventions
- Mezigdomide — DRUGSpecified dose on specified days
Study Details
The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.
Key Dates
- Start date
- Mar 21, 2024
- Status verified
- May 2025
- Primary completion
- Nov 15, 2024
- Completion
- Nov 15, 2024
Study Design
- Enrollment
- 26 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Group A: Participants with severe renal impairment
- Experimental: Group B: Participants with End Stage Renal Disease
- Experimental: Group C: Participants with normal renal function
Primary Outcome Measure
Maximum observed concentration (Cmax) [ Time Frame: Up to 24 days ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| PANAX | Miami Lakes | Florida | 33014 | - |
| Omega Research Group - Orlando | Orlando | Florida | 32806 | - |
| Orlando Clinical Research Center OCRC | Orlando | Florida | 32809 | - |
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