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The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Participants with severe renal impairment | Experimental |
| |
| Group B: Participants with End Stage Renal Disease | Experimental |
| |
| Group C: Participants with normal renal function | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mezigdomide | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PANAX | Miami Lakes | Florida | 33014 | United States | ||
| Omega Research Group - Orlando |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
See plan description
See plan description
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| 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 |
| Orlando |
| Florida |
| 32806 |
| United States |
| Orlando Clinical Research Center OCRC | Orlando | Florida | 32809 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |