An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects

Study Overview
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Brief Summary
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This is a study to investigate the experimental medication BMS-986165 in healthy participants in order to study the effects it has on electrocardiogram results.

Official Title
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A Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy Subjects

Conditions
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Systemic Lupus Erythematosus, Healthy Participants

Intervention / Treatment
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* Drug: BMS-986165
* Drug: Moxifloxacin
* Other: Placebo


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 no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator Body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 mL/min/1.732 m2 Exclusion Criteria: Any medical condition that presents a potential risk and/or may compromise the objectives of the study, including a history or presence of active liver disease A personal history of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure) History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age Other protocol defined inclusion/exclusion criteria could 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986165 Dose 1 oral administration<br>BMS-986165 therapeutic single dose | Drug: BMS-986165<br>* Specified dose on specified days<br>|
| Experimental: BMS-986165 Dose 2 oral administration<br>BMS-986165 supratherapeutic single dose | Drug: BMS-986165<br>* Specified dose on specified days<br>|
| Active Comparator: Moxifloxacin Dose 3 oral administration<br>Moxifloxacin positive control single dose | Drug: Moxifloxacin<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo Dose 4 oral administration<br>Placebo single dose | Other: Placebo<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 |
| --- | --- | --- |
| Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG) |  | From baseline to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placebo-corrected change from baseline in corrected (Fridericia) QT Interval (QTcF) for moxifloxacin as determined by 12-lead ECG |  | From baseline to 5 days | 
| Heart rate (HR) as determined by 12-lead ECG |  | 5 days | 
| QRS as determined by 12-lead ECG |  | 5 days | 
| PR as determined by 12-lead ECG |  | 5 days | 
| Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG |  | From baseline to 5 days | 
| Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations |  | Up to 28 days | 
| Incidence of adverse events (AE) |  | Up to 28 days | 
| Incidence of serious adverse events (SAE) |  | Up to 28 days | 
| Maximum observed concentration (Cmax) as determined by plasma concentration |  | 5 days | 
| Time of maximum observed concentration (Tmax) as determined by plasma concentration |  | 5 days | 
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] as determined by plasma concentration |  | 5 days | 
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration |  | 5 days |