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The purpose of this study is to evaluate the drug levels of BMS-986165 in when taken by mouth as various solid tablet prototypes, by healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Reference Treatment | Experimental |
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| Part A Prototype | Experimental |
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| Part C Reference Treatment | Experimental |
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| Part C: Prototype | Experimental |
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| Part B: Treatment 1 | Experimental |
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| Part B: Treatment 2 | Experimental |
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| Part B: Treatment 3 | Experimental |
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| Part B: Treatment 4 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference Treatment- BMS-986165-01 | Drug | Specified dose on specified days |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986165 | Day 1 and Day 7 | |
| Time of maximum observed plasma concentration (Tmax) of BMS-986165 | Day 1 and Day 7 | |
| Area under the plasma concentration-time curve from time zero to t (AUC (0-t)) of BMS-986165 | Part A, B, C | Day 1 and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Nonserious Adverse Events (AEs) | Up to approximately 60 days (for Parts A & C), approximately 69 days (for Part B) | |
| Incidence of Serious Adverse Events (AEs) | Up to approximately 83 days (for Parts A & C), approximately 92 days (for Part B) |
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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 | 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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| Experimental |
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| Part B: Treatment 5 | Experimental |
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| Prototype BMS-986165 | Drug | Specified dose on specified days |
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| Famotidine | Drug | Specified dose on specified days |
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| Alcohol | Other | Specified quantity on specified days |
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| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) |
| Incidence of clinically significant changes in electrocardiogram (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 approximately 53 days (for Parts A & C), approximately 62 days (for Part B) |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS | QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) |
| Incidence of clinically significant changes in electrocardiogram (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 approximately 53 days (for Parts A & C), approximately 62 days (for Part B) |
| 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 approximately 53 days (for Parts A & C), approximately 62 days (for Part B) |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
| D015738 | Famotidine |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000438 | Alcohols |
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