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A Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-985165-01 prototype formulation 1 | Experimental |
| |
| BMS-986165 Tablet | Experimental |
| |
| BMS-985165-01 prototype formulation 2 | Experimental |
| |
| BMS-985165-01 prototype formulation 3 | Experimental |
| |
| BMS-985165-01 prototype formulation 3 or 4 | Experimental |
| |
| BMS-985165-01 prototype formulation 3, 4 or 5 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165-01 | Drug | Participants will receive BMS- 986165 -01 in prototype formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) for BMS-986165 | Day 1 of treatment | |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration- AUC(0-T) for BMS- 986165 | Day 1 of treatment | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time- AUC(INF) for BMS-986165 | Day 1 of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum observed plasma concentration-(Tmax) for BMS -986165 | Day 1 of treatment | |
| Apparent plasma elimination half-life- (T-HALF) for BMS-986165 | Day 1 of treatment | |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Nottingham | NG11 6JS | United Kingdom |
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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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| BMS-986165 Tablet | Drug | Participants will receive BMS-986165 in tablet form. |
|
| Famotidine | Drug | Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine |
|
| Area under the concentration-time curve from time zero to 24 hours post- (AUC 0-24) for BMS-986165 |
| Day 1 of treatment |
| Apparent clearance -(CL/F) for BMS-986165 | Day 1 of treatment |
| Concentration observed at 24 hours-(C24) for BMS-986165 | Day 1 of treatment |
| Concentration observed at 12 hours-(C12) for BMS-986165 | Day 1 of treatment |
| Incidence of non-serious adverse events(AE's) leading to discontinuation of study therapy. | Approximately 16 weeks |
| Incidence of serious adverse events (SAE) leading to discontinuation of study therapy. | Approximately 16 weeks. |
| Incidence of adverse events (AEs) leading to discontinuation of study therapy. | Approximately 16 weeks. |
| FDA Safety Alerts and Recalls | View source |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |