the Effect of Moxifloxacin on QT/QTc IntervalPhase 1NCT01756521
A Study Study to Investigate the Effect on QT/QTc Interval of Moxifloxacin After a Single Dose in Healthy Male Subjects
A Phase 1 study testing Moxifloxacin in people with the Effect of Moxifloxacin on QT/QTc Interval, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- the Effect of Moxifloxacin on QT/QTc Interval
- What is being tested?
- Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 :
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Moxifloxacin
- Keywords
- QT,, QTc,, electrocardiogram,, moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin 400mg | Experimental | moxifloxacin 400mg Receives: Drug: Moxifloxacin |
| Moxifloxacin 800mg | Experimental | moxifloxacin 800mg Receives: Drug: Moxifloxacin |
| Placebo(No treatment) | Placebo comparator | Only drink water Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day1 and Day2 of each periods(3 periods)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Effect of Moxifloxacin on QT/QTc IntervalStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea National Enterprise for Clinical Trials, The Catholic University of Korea, Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Kyung-Sang Yu, Seoul National University Hospital
- Investigators
- Kyung-Sang Yu, MD, Ph.D., Principal investigator, Seoul National University Hospital and College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756521
- Sponsor's protocol ID
- MOXI036
- Status last verified
- Apr 2016
- First submitted
- 20 Dec 2012
- Last updated
- 26 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01756521
- Acronym / sponsor ID
- MOXI036
- Keywords
- QT,, QTc,, electrocardiogram,, moxifloxacin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korea National Enterprise for Clinical Trials, The Catholic University of Korea, Seoul National University Bundang Hospital
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin 400mg | Experimental | Drug: Moxifloxacinmoxifloxacin 400mg |
| Moxifloxacin 800mg | Experimental | Drug: Moxifloxacinmoxifloxacin 800mg |
| Placebo(No treatment) | Placebo comparator | Drug: MoxifloxacinOnly drink water |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxifloxacin | Drug | Moxifloxacin 400mg, Moxifloxacin 800mg, Placebo(No treatment) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- webpage of clinical trial center of Seoul National University HospitalLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-Sang Yu, MD, Ph.D. principal investigator
Seoul National University Hospital and College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Moxifloxacin in people with the Effect of Moxifloxacin on QT/QTc Interval, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QTc (QTcF, QTcB, QTcI) (time frame: Day1 and Day2 of each periods(3 periods)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.