Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-24 @ 4:13 PM
Study NCT ID:
NCT03822520
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2018-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2018-11-08', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in QTc interval, read manually', 'timeFrame': '-1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day', 'description': 'which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.'}], 'secondaryOutcomes': [{'measure': 'Change in QTc , measured automatically', 'timeFrame': '-1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day', 'description': 'which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.'}, {'measure': 'ventricular rate, measured automatically', 'timeFrame': '-1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day', 'description': 'which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.'}, {'measure': 'PR duration, measured automatically', 'timeFrame': '-1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day', 'description': 'which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.'}, {'measure': 'RR duration, measured automatically', 'timeFrame': '-1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day', 'description': 'which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.'}, {'measure': 'QRS duration, measured automatically', 'timeFrame': '-1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day', 'description': 'which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.'}, {'measure': 'Area under the curve within a dosing interval at steady state', 'timeFrame': '0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)', 'description': 'which is analyzed at the date of final administration of celecoxib'}, {'measure': 'Maximum concentration at steady state', 'timeFrame': '0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)', 'description': 'which is analyzed at the date of final administration of celecoxib'}, {'measure': 'Time to maximum concentration at steady state', 'timeFrame': '0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)', 'description': 'which is analyzed at the date of final administration of celecoxib'}, {'measure': 'Minimum concentration at steady state', 'timeFrame': '0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)', 'description': 'which is analyzed at the date of final administration of celecoxib'}, {'measure': 'Area under the concentration-time curve time zero to the time of the last quantifiable concentration', 'timeFrame': '0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)', 'description': 'which is analyzed at the date of final administration of moxifloxacin'}, {'measure': 'Maximum concentration', 'timeFrame': '0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)', 'description': 'which is analyzed at the date of final administration of moxifloxacin'}, {'measure': 'Time to maximum concentration', 'timeFrame': '0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)', 'description': 'which is analyzed at the date of final administration of moxifloxacin'}, {'measure': 'Half-life', 'timeFrame': '0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)', 'description': 'which is analyzed at the date of final administration of moxifloxacin'}, {'measure': 'The apparent clearance', 'timeFrame': '0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)', 'description': 'which is analyzed at the date of final administration of moxifloxacin'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Qt Interval, Variation in']}, 'referencesModule': {'references': [{'pmid': '31564512', 'type': 'DERIVED', 'citation': 'Kim S, Lee H, Ko JW, Kim JR. Effects of Celecoxib on the QTc Interval: A Thorough QT/QTc Study. Clin Ther. 2019 Nov;41(11):2204-2218. doi: 10.1016/j.clinthera.2019.09.004. Epub 2019 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted to evaluate effect on QT/QTc Interval after multiple dose of celecoxib among healthy adult volunteers. It is randomized, open-label, negative and postive control, and crossover study. Volunteers will be mainly checked up through ECG to find out changes of QT/QTc interval during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adults between 19-year-old and 40-year-old during the screening day\n* BMI between 19 kg/m² and 30 kg/m² during the screening day\n* Be able to give an informed consent form after understanding for reasonable explanation of clinical trial's purpose, contents and characteristics of clinical drugs\n* Wiling to participate whole clinical trial periods\n\nExclusion Criteria:\n\n* Person who is able to clinically affect to the study through ECG result during the screening day\n* Has critical issue for Torsade de points from heart failure, hypopotassemia, arrhythmia etc., or family history for long QT syndrome, sudden cardiac death.\n* Was suffered, or is suffering from like liver, kidney, digestive system, circulatory system, respiratory system, endocrine system(except diabetes), musculoskeletal, neuropsychiatry, or hemato-oncology etc., which is able to effect on clinical study\n* Has allergy which is required the treatment or hypersensitive from drugs such as aspirin, anti-biotics, anti-depressants, etc.\n* Was administered any drug of other clinical study within 90 days from the randomization day.\n* Donated whole blood within 60days or apheresis within 30 days from the randomization day.\n* Took any medicine or oriental medicine within 2 weeks, or general pharmaceuticals within 7 days from the randomization day. (For general pharmaceuticals circumstances, PI could decide whether he/she is suitable for the study)\n* No intention to take contraceptive which is approved as clinical way, or is planning on giving their sperm or egg during the whole clinical trial.\n* Average alcohol consumption per week: \\>140g\n* Average smoking per day: \\>20\n* Average grapefruit juice consumption per day: \\>4 glasses\n* systolic blood pressure \\<100 mmHg or \\>150 mmHg, or diastolic pressure \\<70 mmHg or \\>100mmHg\n* Over 2 times from the maximum reference interval of AST and ALT levels in the blood.\n* eGFR by MDRD from creatinine in the blood is less than 30 mL/min.\n* doesn't show negative reaction from HIV Test, B hepatitis test, or C hepatitis test\n* For woman, doesn't show negative reaction from pregnancy test\n* PI decides the person is not suitable to participate the clinical study with other reasons."}, 'identificationModule': {'nctId': 'NCT03822520', 'briefTitle': 'Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A Randomized, Open-label, Negative and Positive Control, Crossover Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': '2016-11-053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Celecoxib, Moxifloxacin, Water in order', 'description': '1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days\n\n Wash-out period (3\\~6 days)\n2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day\n\n Wash-out period (3\\~6 days)\n3. Intervention Pure water: Water 150ml by mouth without any drug, once for one day', 'interventionNames': ['Drug: Celecoxib', 'Drug: Moxifloxacin', 'Other: Water']}, {'type': 'EXPERIMENTAL', 'label': 'Celecoxib, Water, Moxifloxacin in order', 'description': '1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days\n\n Wash-out period (3\\~6 days)\n2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day\n\n Wash-out period (3\\~6 days)\n3. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day', 'interventionNames': ['Drug: Celecoxib', 'Drug: Moxifloxacin', 'Other: Water']}, {'type': 'EXPERIMENTAL', 'label': 'Moxifloxacin, Water, Celecoxib in order', 'description': '1. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day\n\n Wash-out period (3\\~6 days)\n2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day\n\n Wash-out period (3\\~6 days)\n3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days', 'interventionNames': ['Drug: Celecoxib', 'Drug: Moxifloxacin', 'Other: Water']}, {'type': 'EXPERIMENTAL', 'label': 'Water, Moxifloxacin, Celecoxib in order', 'description': '1. Intervention Pure water: Water 150ml by mouth without any drug, once for one day\n\n Wash-out period (3\\~6 days)\n2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day\n\n Wash-out period (3\\~6 days)\n3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days', 'interventionNames': ['Drug: Celecoxib', 'Drug: Moxifloxacin', 'Other: Water']}], 'interventions': [{'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex'], 'description': 'Celecoxib 400mg capsule', 'armGroupLabels': ['Celecoxib, Moxifloxacin, Water in order', 'Celecoxib, Water, Moxifloxacin in order', 'Moxifloxacin, Water, Celecoxib in order', 'Water, Moxifloxacin, Celecoxib in order']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'otherNames': ['Avelox'], 'description': 'Moxifloxacin 400mg tablet', 'armGroupLabels': ['Celecoxib, Moxifloxacin, Water in order', 'Celecoxib, Water, Moxifloxacin in order', 'Moxifloxacin, Water, Celecoxib in order', 'Water, Moxifloxacin, Celecoxib in order']}, {'name': 'Water', 'type': 'OTHER', 'description': 'Pure water 150ml', 'armGroupLabels': ['Celecoxib, Moxifloxacin, Water in order', 'Celecoxib, Water, Moxifloxacin in order', 'Moxifloxacin, Water, Celecoxib in order', 'Water, Moxifloxacin, Celecoxib in order']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'JUNGRYUL KIM, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jung-Ryul Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}