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The purpose of this study is to characterize the pharmacokinetics (the way the body absorbs, distributes and eliminates the drug) of BMS 986165 given in the form of various prototypes of solid tablets to healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A : BMS-986165 | Experimental |
| |
| Treatment B: BMS-986165 prototype 1 | Experimental |
| |
| Treatment C: BMS-986165 prototype 2 | Experimental |
| |
| Treatment D: BMS-986165 prototype 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) for BMS-986165 in plasma | Up to 18 days | |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) for BMS-986165 in plasma | Up to 18 days | |
| Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) for BMS-986165 in plasma | Up to 18 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 23 days | |
| Incidence of Serious Adverse Events (SAEs) | Up to 55 days | |
| Number of clinically significant abnormalities in electrocardiogram (ECG) parameters |
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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 apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Miami | Miami | Florida | 33126 | United States |
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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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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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| BMS-986165 prototype 1 |
| Drug |
Specified dose on specified days |
|
| BMS-986165 prototype 2 | Drug | Specified dose on specified days |
|
| Up to 50 days |
| Number of participants with vital sign abnormalities in body temperature | Up to 50 days |
| Number of participants with vital sign abnormalities in respiratory rate | Up to 50 days |
| Number of participants with vital sign abnormalities in heart rate | Up to 50 days |
| Number of participants with vital sign abnormalities in blood pressure | Up to 50 days |
| Number of participants with clinical laboratory test abnormalities: Hematology tests | Up to 50 days |
| Number of participants with clinical laboratory test abnormalities: Clinical chemistry tests | Up to 50 days |
| Number of participants with clinical laboratory test abnormalities: Urinalysis tests | Up to 50 days |
| FDA Safety Alerts and Recalls | View source |