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The purpose of this study is to assess the drug levels of deucravacitinib after oral administration in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental |
| |
| Part B | Experimental |
| |
| Part C | Experimental |
| |
| Part D | 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) of deucravacitinib | Up to 7 days | |
| Area Under the Concentration-time Curve from time 0 to 24 hours postdose (AUC(0-24)) of deucravacitinib | Up to 7 days | |
| Concentration at 24 hours of post-morning dose on Day 1 and Day 7 (C24) of deucravacitinib | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of non-serious Adverse Events (AEs) | Up to 18 days | |
| Incidence of Serious Adverse Events (SAEs) | Up to 30 days post discontinuation of dosing or participant's participation in the study |
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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 | ||
| PPD Development, LP |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls |
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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 | Specified dose on specified days |
|
|
| Incidence of clinically significant changes in clinical laboratory values: Hematology tests | Up to 11 days |
| Incidence of clinically significant changes in clinical laboratory values: Chemistry tests | Up to 11 days |
| Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests | Up to 11 days |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 11 days |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 11 days |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 11 days |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 11 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | PR interval is the time from the onset of the P wave to the start of the QRS complex | Up to 11 days |
| Incidence of clinically significant changes in ECG parameters: QRS | QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization | Up to 11 days |
| Incidence of clinically significant changes in ECG parameters: QT interval | The QT interval is the time from the start of the Q wave to the end of the T wave | Up to 11 days |
| Incidence of clinically significant changes in ECG parameters: QTcF | QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave | Up to 11 days |
| Austin |
| Texas |
| 78744 |
| United States |
| Investigator Inquiry Form | View source |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |