Effect of BMS-986165 on the Blood Levels of Metformin

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Two-arm Crossover Study to Investigate the Effect of BMS-986165 on the Pharmacokinetics of Metformin in Healthy Volunteers

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986165
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy, as determined by having no clinically significant deviation from normal in medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory determinations Body mass index of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening Must agree to follow specific methods of contraception, if applicable 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: BMS-986165 Dose 1 + Metformin<br> | Drug: BMS-986165<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;Drug: Metformin<br>* Specified dose on specified days<br>|
| Experimental: Arm 2: BMS-986165 Dose 2 + Metformin<br> | Drug: BMS-986165<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;Drug: Metformin<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug interaction, Metformin, Pharmacodynamics, Pharmacokinetics