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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002533-38 | EudraCT Number |
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The purpose of this study is to investigate BMS-986165 in participants with different levels of kidney function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal renal function | Experimental | Single dose |
|
| Mild renal disease | Experimental | Single dose |
|
| Moderate renal failure | Experimental | Single dose |
|
| Severe renal failure | Experimental | Single dose |
|
| End-stage renal disease requiring dialysis | Experimental | Two single doses administered with washout |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Approximately 9 days | |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] | Approximately 9 days | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | Approximately 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation | Approximately 45 days | |
| Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations | Approximately 45 days |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States | ||
| Pharmaceutical Research Associates CZ, s.r.o |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| Prague |
| 170 00 |
| Czechia |
| Szent Imre Egyetemi Oktatokorhaz | Budapest | 1115 | Hungary |
| Kenezy Gyula Korhaz es Rendelointezet | Debrecen | 4043 | Hungary |
| Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II | Grodzisk Mazowiecki | 05-825 | Poland |
| Specjalistyczne Centrum Medyczne Chirurgii Maloinwazyjnej SCM | Krakow | 31-559 | Poland |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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