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The primary purpose of this study is to evaluate the effects of food and pH on the relative bioavailability (BA) of the tablet formulation of BMS-986165 in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: BMS-986165 alone, fasted | Experimental |
| |
| Treatment B: BMS-986165 alone, fed | Experimental |
| |
| Treatment C: BMS-986165 with famotidine pretreatment, fasted | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 | Drug | Single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition | Day 1 to Day 13 | |
| Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone | Day 1 to Day 13 | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for a tablet dosed with high-fat high-calorie meal versus fasted condition | Day 1 to Day 13 | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone | Day 1 to Day 13 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition | Day 1 to Day 13 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone | Day 1 to Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 39 days | |
| Number of clinically significant changes in vital sign measurements | Up to 18 days | |
| Number of clinically significant changes in clinical laboratory test results |
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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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences - Salt Lake | Salt Lake City | Utah | 84124 | 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 |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Famotidine | Drug | Single dose |
|
| Up to 18 days |
| Number of clinically significant changes in electrocardiogram (ECG) parameters | Up to 18 days |
| FDA Safety Alerts and Recalls | View source |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |