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

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ClinicalTrials.gov Identifier: NCT01756521
Recruitment Status : Completed
First Posted : December 27, 2012
Last Update Posted : April 26, 2016
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

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.

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

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  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. QTc (QTcF, QTcB, QTcI) [ Time Frame: Day1 and Day2 of each periods(3 periods) ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Principal Investigator: Kyung-Sang Yu, MD, Ph.D. Seoul National University Hospital and College of Medicine

Additional Information:
Responsible Party: Kyung-Sang Yu, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01756521     History of Changes
Other Study ID Numbers: MOXI036
First Posted: December 27, 2012    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016

Keywords provided by Kyung-Sang Yu, Seoul National University Hospital:
QT,
QTc,
electrocardiogram,
moxifloxacin

Additional relevant MeSH terms:
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors