Renal Impairment Clinical Trial
Official title:
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
The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.
| Status | Not yet recruiting |
| Enrollment | 32 |
| Est. completion date | March 5, 2025 |
| Est. primary completion date | March 5, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 82 Years |
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | PANAX | Miami Lakes | Florida |
| United States | Local Institution - 0003 | Orlando | Florida |
| United States | Orlando Clinical Research Center OCRC | Orlando | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed concentration (Cmax) | Up to 24 days | ||
| Primary | Area under the plasma concentration-time curve (AUC) | Up to 24 days | ||
| Primary | 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 | ||
| Secondary | Number of participants with serious adverse events (SAEs) | Up to 54 days | ||
| Secondary | Number of participants with physical examination findings | Up to 24 days | ||
| Secondary | Number of participants with vital sign abnormalities | Up to 24 days | ||
| Secondary | Number of participants with 12-lead electrocardiogram (ECG) findings | Up to 24 days | ||
| Secondary | Maximum observed concentration (Cmax) | Up to 24 days | ||
| Secondary | Time of maximum observed concentration (Tmax) | Up to 24 days | ||
| Secondary | Area under the plasma concentration-time curve (AUC) | Up to 24 days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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