A Study Study to Investigate the Effect on QT/QTc Interva... | NCT01756521

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

NCT01756521

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 26, 2016Estimated

Enrollment

39Actual

Phase

Phase 1

Conditions

the Effect of Moxifloxacin on QT/QTc Interval

Interventions

Moxifloxacin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Aug 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Dec 20, 2012

First Submission Date that Met QC Criteria

Dec 20, 2012

First Posted Date

Dec 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2016

Last Update Posted Date

Apr 26, 2016Estimated

Name	Class
Korea National Enterprise for Clinical Trials	OTHER
The Catholic University of Korea	OTHER
Seoul National University Bundang Hospital	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Moxifloxacin	Drug		Moxifloxacin 400mg Moxifloxacin 800mg Placebo(No treatment)

Outcomes Module

Primary Outcomes

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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines