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

Seoul National University

Status and phase: Completed; Phase 1

Conditions: the Effect of Moxifloxacin on QT/QTc Interval

Treatments: Drug: Moxifloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT01756521

MOXI036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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39 participants in 3 patient groups, including a placebo group

Moxifloxacin 400mg

Experimental group

Description:

moxifloxacin 400mg

Treatment:

Drug: Moxifloxacin

Moxifloxacin 800mg

Experimental group

Description:

moxifloxacin 800mg

Treatment:

Drug: Moxifloxacin

Placebo(No treatment)

Placebo Comparator group

Description:

Only drink water

Treatment:

Drug: Moxifloxacin