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The purpose of this study is to evaluate the bioequivalence between immediate release tablets and minitablets of Deucravacitinib (BMS-986165), and the effect of food and pH on the drug levels of the minitablets in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986165 Formulation 1 | Experimental |
| |
| BMS-986165 Formulation 2 | Experimental |
| |
| BMS-986165 Formulation 2 + Fed | Experimental |
| |
| BMS-986165 Formulation 2 + Famotidine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to day 20 | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to day 20 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to day 44 | |
| Incidence of serious adverse events (SAEs) | Up to day 44 | |
| Incidence of AEs leading to discontinuation |
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Inclusion Criteria
Exclusion Criteria
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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 | Austin | Texas | 78744 | United States |
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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/disclosure-commitment.html
See plan description
See plan description
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| Famotidine | Drug | Specified dose on specified days |
|
| Up to day 44 |
| Number of participants with a clinically significant change from baseline in vital signs | Up to day 21 |
| Number of participants with a change from baseline in 12-lead ECG results | Up to day 21 |
| Number of participants with physical examination abnormalities | A physical examination includes the assessment of the following: head, eyes, ears, nose, and throat (HEENT), cardiovascular (including peripheral vascular), lungs, abdomen, dermatological, and a general neurological examination | Up to day 21 |
| Time of maximum observed plasma concentration (Tmax) | Up to day 20 |
| Apparent terminal plasma half-life (T-HALF) | Up to day 20 |
| Apparent total body clearance (CLT/F) | Up to day 20 |
| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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