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The purpose of this study is to assess the drug levels and safety of BMS-986278 in participants with mild, 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: Mild Hepatic Impairment BMS-986278 | Experimental |
| |
| Group B: Moderate Hepatic Impairment BMS-986278 | Experimental |
| |
| Group C: Severe Hepatic Impairment BMS-986278 | Experimental |
| |
| Group D: Normal Hepatic Function BMS-986278 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986278 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to day 9 | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] | Up to day 9 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | Up to day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 62 days | |
| Incidence of serious adverse events (SAEs) | Up to 62 days | |
| Number of participants with physical examination abnormalities |
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Inclusion Criteria:
All Participants:
Mild, Moderate, or Severe Hepatic Impairment Participants:
Matched Healthy Participants:
Exclusion Criteria:
All Participants:
Mild, Moderate, or Severe Hepatic Impairment Participants:
Matched Healthy Participants:
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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 | Miami Lakes | Florida | 33027 | United States | ||
| Local Institution - 0003 |
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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 62 days |
| Number of participants with vital sign abnormalities | Up to 62 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 62 days |
| Number of participants with clinical laboratory abnormalities | Up to 62 days |
| Time of maximum observed concentration (Tmax) | Up to day 9 |
| Terminal elimination half-life (T-HALF) | Up to day 9 |
| Apparent body clearance (CLT/F) | Up to day 9 |
| Maximum observed plasma concentration of unbound drug (Cmax_u) | Up to day 9 |
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration of unbound drug [AUC(0-T)_u] | Up to day 9 |
| Area under the plasma concentration-time curve from time 0 extrapolated to infinite time of unbound drug [AUC(INF)_u] | Up to day 9 |
| Orlando |
| Florida |
| 32809 |
| United States |
| Local Institution - 0002 | Tampa | Florida | 33618 | United States |
| Local Institution - 0004 | 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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