The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects
A Randomized, Double-blind, Placebo-controlled, Two-way Crossover Trial to Compare Moxifloxacin Induced QT Interval Prolongation in Japanese and Korean Healthy Subjects
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Nov 2011
Typical duration for not_applicable healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 9, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedJune 12, 2013
June 1, 2013
10 months
June 9, 2013
June 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
double delta QTcF
12 point of ECG measurements according to the interventions
up to 24 hours
Secondary Outcomes (1)
double delta QTcI, double delta QTcSS
up to 24 hours
Study Arms (2)
Moxifloxacin
ACTIVE COMPARATORsingle oral administration of 400mg of moxifloxacin
Placebo
PLACEBO COMPARATORsingle oral administration of 400mg of placebo
Interventions
single oral administration of 400mg of moxifloxacin
Eligibility Criteria
You may qualify if:
- \- 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.
- \) Body Mass Index (BMI) of 17.6 to 26.4 kg/m2, BMI = weight (kg)/ \[height (m)\]2.
You may not qualify if:
- \) 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.
- \) 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
- QTcF: male ≥ 450 msec, female ≥470msec
- Iincomplete right bundle branch block
- Marked Sinus Arrhythmia
- Wondering pacemaker
- Atrial rhythm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inje Universitylead
Related Publications (1)
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.
PMID: 28003052DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae-Gook Shin, MD, PhD
Inje University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Pharmacology and Pharmacogenomics Research Center
Study Record Dates
First Submitted
June 9, 2013
First Posted
June 12, 2013
Study Start
November 1, 2011
Primary Completion
September 1, 2012
Study Completion
January 1, 2013
Last Updated
June 12, 2013
Record last verified: 2013-06