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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01756521

Enrollment

Registered

2012-12-27

Start date

2013-01-31

Completion date

2013-10-31

Last updated

2016-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the Effect of Moxifloxacin on QT/QTc Interval

Keywords

QT,, QTc,, electrocardiogram,, moxifloxacin

Brief 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.

Detailed description

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.

Interventions

DRUGMoxifloxacin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
QTc (QTcF, QTcB, QTcI)	Day1 and Day2 of each periods(3 periods)	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026