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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Korea National Enterprise for Clinical Trials; Seoul National University Bundang Hospital; The Catholic University of Korea
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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