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The purpose of this study is to assess the drug levels and safety of golcadomide (BMS-986369) in adult participants with moderate and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: BMS-986369 Moderate Hepatic Impairment | Experimental |
| |
| Group B: BMS-986369 Severe Hepatic Impairment | Experimental |
| |
| Group C: BMS-986369 Normal Hepatic Function | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986369 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to approximately 44 days | |
| Time of maximum observed plasma concentration (Tmax) | Up to approximately 44 days | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] | Up to approximately 44 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to approximately 44 days | |
| Incidence of serious adverse events (SAEs) | Up to approximately 44 days | |
| Number of participants with physical examination abnormalities |
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Inclusion Criteria for all Participants (Group A, Group B, Group C):
Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group A and Group B):
Inclusion Criteria for a Matched Healthy Participant (Group C):
Exclusion Criteria for all Participants (Group A, Group B, and Group C):
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Chandler | Arizona | 85225 | United States | ||
| Local Institution - 0002 |
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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/disclosurecommitment.html
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|
| Up to approximately 44 days |
| Number of participants with vital sign abnormalities | Up to approximately 44 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to approximately 44 days |
| Number of participants with clinical safety laboratory test abnormalities | Up to approximately 44 days |
| Orlando |
| Florida |
| 32809 |
| United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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