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The purpose of this study is to identify drug levels of gastro-retentive (GR) formulations which prolong retaining time in the stomach of deucravacitinib (BMS-986165) in Healthy Participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Deucravacitinib | Experimental |
| |
| Part B: Deucravacitinib | 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 approximately 5 days | |
| Concentration at 24 hours post dose (C24) | Up to approximately 5 days | |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] | Up to approximately 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to approximately 1 month | |
| Incidence of serious adverse events (SAEs) | Up to approximately 1 month | |
| 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 | Nottingham | Nottinghamshire | NG11 6JS | United Kingdom |
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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/disclosurecommitment.html
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 10, 2026 | |
| Reset | Jul 7, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 10, 2026 | Jul 7, 2026 |
| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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| Up to approximately 1 month |
| Incidence of participants with vital sign abnormalities | Up to approximately 1 month |
| Incidence of participants with electrocardiogram (ECG) abnormalities | Up to approximately 1 month |
| Incidence of participants with physical examinations abnormalities | Up to approximately 1 month |
| Incidence of participants with clinical laboratory abnormalities | Up to approximately 1 month |
| Time of maximum observed concentration (Tmax) | Up to approximately 5 days |
| Apparent terminal plasma half-life (T-HALF) | Up to approximately 5 days |
| Apparent total body clearance (CLT/F) | Up to approximately 5 days |