A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment
- Registration Number
- NCT06318676
- Lead Sponsor
- Celgene
- Brief Summary
The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group C: Participants with normal renal function Mezigdomide - Group B: Participants with End Stage Renal Disease Mezigdomide - Group A: Participants with severe renal impairment Mezigdomide -
- Primary Outcome Measures
Name Time Method Maximum observed concentration (Cmax) Up to 24 days Area under the plasma concentration-time curve (AUC) Up to 24 days Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) Up to 24 days
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration-time curve (AUC) Up to 24 days Number of participants with adverse events (AEs) Up to 54 days Number of participants with serious adverse events (SAEs) Up to 54 days Number of participants with physical examination findings Up to 24 days Number of participants with vital sign abnormalities Up to 24 days Number of participants with 12-lead electrocardiogram (ECG) findings Up to 24 days Maximum observed concentration (Cmax) Up to 24 days Time of maximum observed concentration (Tmax) Up to 24 days
Trial Locations
- Locations (3)
PANAX
🇺🇸Miami Lakes, Florida, United States
Omega Research Group - Orlando
🇺🇸Orlando, Florida, United States
Orlando Clinical Research Center OCRC
🇺🇸Orlando, Florida, United States
PANAX🇺🇸Miami Lakes, Florida, United States