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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- QTc (QTcF, QTcB, QTcI)
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Moxifloxacin 400mg
moxifloxacin 400mg
Intervention: Moxifloxacin (Drug)
Moxifloxacin 800mg
moxifloxacin 800mg
Intervention: Moxifloxacin (Drug)
Placebo(No treatment)
Only drink water
Intervention: Moxifloxacin (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Kyung-Sang Yu
Professor
Seoul National University Hospital