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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: the Effect of Moxifloxacin on QT/QTc Interval

Intervention: Moxifloxacin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Seoul National University Hospital


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: QTc (QTcF, QTcB, QTcI)


Minimum age: 20 Years. Maximum age: 40 Years. Gender(s): Male.


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

Locations and Contacts

Seoul National University Hospital, Seoul, Korea, Republic of
Additional Information

webpage of clinical trial center of Seoul National University Hospital

Starting date: January 2013
Last updated: December 4, 2013

Page last updated: August 23, 2015

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