HealthyNCT01876316
The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects
A study testing Moxifloxacin in people with Healthy, run by Inje University.
Trial summary
The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jan 2013
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Subjects in Japan and Korea deemed healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, or clinical laboratory determinations.
- 2) Body Mass Index (BMI) of 17.6 to 26.4 kg/m2, BMI = weight (kg)/ [height (m)]2.
Who cannot join
- 1) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
- 2) Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat.
- Heart rate ≤ 45 bpmmsec or Heart rate ≥ 100 bpmmsec
- PR ≥ 210 msec
- QRS ≥ 120 msec
- QT ≥ 500 msec
Show all 11Show fewer
- QTcF: male ≥ 450 msec, female ≥470msec
- Iincomplete right bundle branch block
- Marked Sinus Arrhythmia
- Wondering pacemaker
- Atrial rhythm
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Two-way Crossover Trial to Compare Moxifloxacin Induced QT Interval Prolongation in Japanese and Korean Healthy Subjects
The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects
Read the detailed description
The purpose of this study is to explore the ethnic and gender difference in the Moxifloxacin induced QT interval prolongation between Japanese and Korean subjects.
- Conditions
- Healthy
- Being tested
- Moxifloxacin, Placebo
- Keywords
- Moxifloxacin, QT interval prolongation, Korean, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
Also called Avelox
single oral administration of 400mg of moxifloxacin
PlaceboDrug
Also called Lactose
single oral administration of 400mg of placebo
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin | Active comparator | single oral administration of 400mg of moxifloxacin Receives: Drug: Moxifloxacin |
| Placebo | Placebo comparator | single oral administration of 400mg of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
double delta QTcF
12 point of ECG measurements according to the interventions
Measured: up to 24 hours
Secondary outcomes (1)
double delta QTcI, double delta QTcSS
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Gook Shin, Inje University
- Investigators
- Jae-Gook Shin, MD, PhD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876316
- Sponsor's protocol ID
- 12-166
- Status last verified
- Jun 2013
- First submitted
- 9 Jun 2013
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Choi HK, Jung JA, Fujita T, Amano H, Ghim JL, Lee DH, Tabata K, Song ID, Maeda M, Kumagai Y, Mendzelevski B, Shin JG. Population Pharmacokinetic-Pharmacodynamic Analysis to Compare the Effect of Moxifloxacin on QT Interval Prolongation Between Healthy Korean and Japanese Subjects. Clin Ther. 2016 Dec;38(12):2610-2621. doi: 10.1016/j.clinthera.2016.10.011.
PubMed 28003052
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Two-way Crossover Trial to Compare Moxifloxacin Induced QT Interval Prolongation in Japanese and Korean Healthy Subjects
- ClinicalTrials.gov ID
- NCT01876316
- Acronym / sponsor ID
- 12-166
- Conditions
- Healthy
- Keywords
- Moxifloxacin, QT interval prolongation, Korean, Japanese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Jun 2013 (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 Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects
Detailed description
The purpose of this study is to explore the ethnic and gender difference in the Moxifloxacin induced QT interval prolongation between Japanese and Korean subjects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin | Active comparator | Drug: Moxifloxacinsingle oral administration of 400mg of moxifloxacin |
| Placebo | Placebo comparator | Drug: Placebosingle oral administration of 400mg of placebo |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1) Subjects in Japan and Korea deemed healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, or clinical laboratory determinations.
- 2) Body Mass Index (BMI) of 17.6 to 26.4 kg/m2, BMI = weight (kg)/ [height (m)]2.
Key exclusion criteria (11 listed)
- 1) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
- 2) Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat.
- Heart rate ≤ 45 bpmmsec or Heart rate ≥ 100 bpmmsec
- PR ≥ 210 msec
- QRS ≥ 120 msec
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 |
|---|---|---|
| MoxifloxacinAlso: Aveloxsingle oral administration of 400mg of moxifloxacin | Drug | Moxifloxacin |
| PlaceboAlso: Lactosesingle oral administration of 400mg of placebo | Drug | Placebo |
Primary outcome
double delta QTcF
Time frame: up to 24 hours
12 point of ECG measurements according to the interventions
1 secondary outcome
double delta QTcI, double delta QTcSS
Time frame: up to 24 hours
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 12 Jun 2013.
- Derived from this study: PubMed 28003052Choi HK, Jung JA, Fujita T, Amano H, Ghim JL, Lee DH, Tabata K, Song ID, Maeda M, Kumagai Y, Mendzelevski B, Shin JG. Population Pharmacokinetic-Pharmacodynamic Analysis to Compare the Effect of Moxifloxacin on QT Interval Prolongation Between Healthy Korean and Japanese Subjects. Clin Ther. 2016 Dec;38(12):2610-2621. doi: 10.1016/j.clinthera.2016.10.011.
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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.
Jae-Gook Shin, MD, PhD principal investigator
Inje University
Questions about this trial
What is this clinical trial studying?
A study testing Moxifloxacin in people with Healthy, run by Inje University.
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 2 inclusion and 11 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 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
double delta QTcF (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01876316, which also lists 1 linked publication.
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 12 Jun 2013.