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

NCT01756521 | Completed Phase 1

• 1 other identifier: MOXI036
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

the Effect of Moxifloxacin on QT/QTc Interval

Keywords

QT,; QTc,; electrocardiogram,; moxifloxacin

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Moxifloxacin 400mg

EXPERIMENTAL

moxifloxacin 400mg

Drug: Moxifloxacin

Moxifloxacin 800mg

EXPERIMENTAL

moxifloxacin 800mg

Drug: Moxifloxacin

Placebo(No treatment)

PLACEBO COMPARATOR

Only drink water

Drug: Moxifloxacin

Interventions

Moxifloxacin DRUG

Moxifloxacin 400mg; Moxifloxacin 800mg; Placebo(No treatment)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Korea National Enterprise for Clinical Trials: collaborator
• The Catholic University of Korea: collaborator
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Links

• webpage of clinical trial center of Seoul National University Hospital

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kyung-Sang Yu, MD, Ph.D.

  Seoul National University Hospital and College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 27, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 26, 2016

Record last verified: 2016-04

Locations

KR (1)