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

This study has been completed.
Sponsor:
Collaborators:
Korea National Enterprise for Clinical Trials
The Catholic University of Korea
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Kyung-Sang Yu, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01756521
First received: December 20, 2012
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
the Effect of Moxifloxacin on QT/QTc Interval
Drug: Moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • QTc (QTcF, QTcB, QTcI) [ Time Frame: Day1 and Day2 of each periods(3 periods) ] [ Designated as safety issue: Yes ]

    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



Enrollment: 39
Study Start Date: January 2013
Study Completion Date: October 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moxifloxacin 400mg
moxifloxacin 400mg
Drug: Moxifloxacin
Experimental: Moxifloxacin 800mg
moxifloxacin 800mg
Drug: Moxifloxacin
Placebo Comparator: Placebo(No treatment)

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756521

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Korea National Enterprise for Clinical Trials
The Catholic University of Korea
Seoul National University Bundang Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Kyung-Sang Yu, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01756521     History of Changes
Other Study ID Numbers: MOXI036
Study First Received: December 20, 2012
Last Updated: December 4, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
QT,
QTc,
electrocardiogram,
moxifloxacin

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014