| Trial ID: | L1444 |
| Source ID: | NCT06318676
|
| Associated Drug: |
Mezigdomide
|
| Title: |
A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Impairment
|
| Interventions: |
DRUG: Mezigdomide
|
| Outcome Measures: |
Primary: 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: 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|Area under the plasma concentration-time curve (AUC), Up to 24 days
|
| Sponsor/Collaborators: |
Sponsor: Celgene
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-03-21
|
| Completion Date: |
2025-03-05
|
| Results First Posted: |
|
| Last Update Posted: |
2024-07-15
|
| Locations: |
PANAX, Miami Lakes, Florida, 33014, United States|Omega Research Group - Orlando, Orlando, Florida, 32808, United States|Orlando Clinical Research Center OCRC, Orlando, Florida, 32809, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06318676
|
