A Study Study to Investigate the Effect on QT/QTc Interval of Moxifloxacin After a Single Dose in Healthy Male Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate effect of moxifloxacin on QT/QTc interval in healthy male subjects. Moxifloxacin is a positive control drug used in QT study. In this study, moxifloxacin 400mg and 800mg will be used, to get information on effect of moxifloxacin on QT/QTc interval.

Detailed Description
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The purpose of this study is to evaluate effect of moxifloxacin on QT/QTc interval in healthy male subjects. Moxifloxacin is a positive control drug used in QT study. In this study, moxifloxacin 400mg and 800mg will be used, (therapeutic and supratherapeutic doses) to get information on effect of moxifloxacin on QT/QTc interval in healthy Korean male subjects.

Official Title
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A Multi-center, Randomized, Open-label, Placebo-controlled, 3-way Crossover Study to Investigate the Effect on QT/QTc Interval of Moxifloxacin After a Single Dose in Healthy Male Subjects

Conditions
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the Effect of Moxifloxacin on QT/QTc Interval

Intervention / Treatment
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* Drug: Moxifloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male subject aged 20 to 40 at screening subjects who have weight over 50 kg with ideal body weight range of +- 20% subjects who decide to participate voluntarily and write a informed consent form Exclusion Criteria: subjects who have acute illness within 28 days of investigational drug administration subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor subjects who have determined not eligible by screening test (medical history, physical examination, 12-lead ECG, laboratory test, etc) within 28 days of study start clinically significant allergic disease (except for mild allergic rhinitis) systolic blood pressure>= 140 mmHg, diastolic blood pressure >= 90 mmHg, heart rate > 100 bpm or < 50 bpm result of 12-lead electrocardiogram includes : QTcF > 450 msec PR interval > 200 msec or <110msec Evidence of second- or third-degree atrioventricular (AV) block Pathologic Q waves (defined as Q-wave > 40 msec or depth > 0.5 millivolt Evidence of ventricular pre-excitation, left bundle branch block (LBBB), right bundle branch block (RBBB) Intraventricular conduction delay with QRS > 120 msec risk of Torsade de pointes such as long QT syndrome, family history of sudden death, heart failure, hypokalemia Subjects considered unsuitable for inclusion by the investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxifloxacin 400mg<br>moxifloxacin 400mg | Drug: Moxifloxacin<br> <br> |
| Experimental: Moxifloxacin 800mg<br>moxifloxacin 800mg | Drug: Moxifloxacin<br> <br> |
| Placebo Comparator: Placebo(No treatment)<br>Only drink water | Drug: Moxifloxacin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc (QTcF, QTcB, QTcI) | QTc (QTcF, QTcB, QTcI) QTcF (Fridericia-corrected QTc) QTcB (Bazett-corrected QTc) QTcI (Individual-corrected QTc) QTc change: the largest time-matched, baseline-adjusted least squares mean difference time-matched, baseline-adjusted least squares mean difference | Day1 and Day2 of each periods(3 periods) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QT,, QTc,, electrocardiogram,, moxifloxacin