Clinical trial NCT01756521: A Study Study to Investigate the Effect on QT/QTc Interval of Moxifloxacin After a Single Dose in Healthy Male Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: the Effect of Moxifloxacin on QT/QTc Interval
Keywords: QT,
QTc,
electrocardiogram,
moxifloxacin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korea National Enterprise for Clinical Trials
name: The Catholic University of Korea
name: Seoul National University Bundang Hospital
First posted: 2012-12-27
Enrollment: 39
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: QTc (QTcF, QTcB, QTcI)
timeFrame: Day1 and Day2 of each periods(3 periods)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital and College of Medicine
name: Kyung-Sang Yu, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: