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The aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild hepatic impairment | Experimental |
| |
| Moderate hepatic impairment | Experimental |
| |
| Severe hepatic impairment | Experimental |
| |
| Healthy participants | 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 6 days | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T]) | Up to 6 days | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 6 days | |
| Number of participants with serious adverse events (SAEs) | Up to 6 days | |
| Number of participants with physical examination abnormalities |
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Inclusion Criteria:
Hepatic Impaired Participants:
Matched Healthy Participants:
Exclusion Criteria:
All Participants:
Hepatic Impaired Participants:
-Clinical laboratory test results:
Matched Healthy Participants:
-History of or suspected benign ethnic neutropenia.
Other protocol-defined inclusion/exclusion criteria apply
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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 | ||
| Orlando Clinical Research Center OCRC |
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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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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|
| Up to 6 days |
| Number of participants with vital sign abnormalities | Up to 6 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 6 days |
| Number of participants with clinical laboratory abnormalities | Up to 6 days |
| Metabolic ratio of AUC(0-T) | Up to 6 days |
| Metabolic ratio of AUC(0-INF) | Up to 6 days |
| Orlando |
| Florida |
| 32809 |
| United States |
| The Texas Liver Institute | San Antonio | Texas | 78215 | United States |