Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT01876316
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
2013-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}, {'id': 'D007785', 'term': 'Lactose'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-11', 'studyFirstSubmitDate': '2013-06-09', 'studyFirstSubmitQcDate': '2013-06-11', 'lastUpdatePostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'double delta QTcF', 'timeFrame': 'up to 24 hours', 'description': '12 point of ECG measurements according to the interventions'}], 'secondaryOutcomes': [{'measure': 'double delta QTcI, double delta QTcSS', 'timeFrame': 'up to 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Moxifloxacin', 'QT interval prolongation', 'Korean', 'Japanese'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '28003052', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 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.\n\n2\\) Body Mass Index (BMI) of 17.6 to 26.4 kg/m2, BMI = weight (kg)/ \\[height (m)\\]2.\n\nExclusion Criteria:\n\n* 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.\n\n 2\\) Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat.\n* Heart rate ≤ 45 bpmmsec or Heart rate ≥ 100 bpmmsec\n* PR ≥ 210 msec\n* QRS ≥ 120 msec\n* QT ≥ 500 msec\n* QTcF: male ≥ 450 msec, female ≥470msec\n* Iincomplete right bundle branch block\n* Marked Sinus Arrhythmia\n* Wondering pacemaker\n* Atrial rhythm'}, 'identificationModule': {'nctId': 'NCT01876316', 'briefTitle': 'The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Two-way Crossover Trial to Compare Moxifloxacin Induced QT Interval Prolongation in Japanese and Korean Healthy Subjects', 'orgStudyIdInfo': {'id': '12-166'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin', 'description': 'single oral administration of 400mg of moxifloxacin', 'interventionNames': ['Drug: Moxifloxacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'single oral administration of 400mg of placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Moxifloxacin', 'type': 'DRUG', 'otherNames': ['Avelox'], 'description': 'single oral administration of 400mg of moxifloxacin', 'armGroupLabels': ['Moxifloxacin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Lactose'], 'description': 'single oral administration of 400mg of placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jae-Gook Shin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Pharmacology and Pharmacogenomics Research Center', 'investigatorFullName': 'Jae-Gook Shin', 'investigatorAffiliation': 'Inje University'}}}}