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

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.

Study Overview

• Status: Completed
• Conditions: the Effect of Moxifloxacin on QT/QTc Interval
• Intervention / Treatment: Drug: Moxifloxacin

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moxifloxacin 400mg; moxifloxacin 400mg	Drug: Moxifloxacin
Experimental: Moxifloxacin 800mg; moxifloxacin 800mg	Drug: Moxifloxacin
Placebo Comparator: Placebo(No treatment); Only drink water	Drug: Moxifloxacin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital; The Catholic University of Korea; Korea National Enterprise for Clinical Trials
• Investigators: Principal Investigator: Kyung-Sang Yu, MD, Ph.D., Seoul National University Hospital and College of Medicine

Publications and helpful links

Helpful Links

• Webpage of clinical trial center of Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: December 20, 2012
• First Posted (Estimate): December 27, 2012

Study Record Updates

• Last Update Posted (Estimate): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: moxifloxacin; QTc,; QT,; electrocardiogram,
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: MOXI036