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

Phase 1

Completed

• Conditions: the Effect of Moxifloxacin on QT/QTc Interval
• Interventions: Drug: Moxifloxacin

• Registration Number: NCT01756521
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-27
• Study Start: 2013-01
• Primary Completion: 2013-08
• Study Completion: 2013-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Moxifloxacin 400mg	Moxifloxacin	moxifloxacin 400mg
Moxifloxacin 800mg	Moxifloxacin	moxifloxacin 800mg
Placebo(No treatment)	Moxifloxacin	Only drink water

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of