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The purpose of this study is to investigate the effects of BMS-986165 on the drug levels of metformin in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BMS-986165 Dose 1 + Metformin | Experimental |
| |
| Arm 2: BMS-986165 Dose 2 + Metformin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) in plasma for metformin with and without BMS-986165 | Up to 9 days | |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T)) in plasma for metformin with and without BMS-986165 | Up to 9 days | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for metformin with and without BMS-986165 | Up to 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 13 days | |
| Incidence of serious adverse events (SAEs) | Up to 71 days | |
| Incidence of clinically significant changes in vital signs: Body temperature |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences - Lenexa | Lenexa | Kansas | 66219 | United States |
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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 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin | Drug | Specified dose on specified days |
|
| Up to 41 days |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 41 days |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 41 days |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 41 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 41 days |
| 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 41 days |
| 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 41 days |
| 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 41 days |
| Incidence of clinically significant changes in clinical laboratory values: Hematology tests | Up to 41 days |
| Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests | Up to 41 days |
| Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests | Up to 41 days |
| FDA Safety Alerts and Recalls | View source |