Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of BMS-708163 on the QTc interval (QT interval corrected for heart rate).

Official Title
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Randomized, Double-Blinded, Placebo-Controlled, Open Label Positive- Controlled, Four-Way Crossover Study of the Electrocardiographic Effects of BMS-708163 in Healthy Subjects

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: BMS-708163
* Drug: BMS-708163
* Drug: Placebo
* Drug: Moxifloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55 Healthy subjects Exclusion Criteria: History of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope Sexually active fertile men not using effective birth control (double barrier) if their partners are WOCBP Women who are pregnant or breastfeeding History of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents History of hypokalemia, history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age Any clinically significant ECG abnormality History of seizure disorders History of drowning survival

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-708163 (800 mg)<br> | Drug: BMS-708163<br>* Oral Solution, Oral, 800 mg, Once on Day 1, approximately 14 days<br>|
| Experimental: BMS-708163 (200 mg)<br> | Drug: BMS-708163<br>* Oral Solution, Oral, 200 mg, Once on Day 1, approximately 14 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Once on Day 1, approximately 14 days<br>|
| Active Comparator: Moxifloxacin<br> | Drug: Moxifloxacin<br>* Tablets, Oral, 400 mg, Once on Day 1, approximately 14 days<br>* Other names: Avelox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on the electrocardiographic QT interval corrected for heart rate (QTc) in healthy subjects |  | Serial triplicate ECGs at -60, -40 and -20 minutes prior to dosing: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effects of BMS-708163 on other ECG endpoints (heart rate [HR], QRS and PR intervals), and changes in waveform morphology |  | At -60, -40 and -20 minutes prior to dosing; at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period |