Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-26 @ 2:19 AM
Study NCT ID:
NCT03475459
Status:
COMPLETED
Last Update Posted:
2018-06-28
First Post:
2018-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Arrhythmogenic Effect of NPC-15 (NPC-15-7)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This study is a single-arm, open label, dose escalation study. QT interval will be evaluated by blinding outcome assessor in this study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-03-16', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time matched, baseline-adjusted change in Fridericia-corrected QTc (QTcF) intervals', 'timeFrame': 'Day1 and Day2 of each periods (3 periods)', 'description': 'QTcF interval is a common endpoints to evaluate arrhythmogenic effect of test drug'}], 'secondaryOutcomes': [{'measure': 'Serum melatonin concentration', 'timeFrame': 'Up to 12 hours post dose in each period (3 periods)', 'description': 'NPC-15 is a preparation containing melatonin , therefore the change in blood concentration of melatonin is useful to evaluate the QTc prolongation effect of NPC-15.'}, {'measure': 'Maximum drug concentration (Cmax) of melatonin', 'timeFrame': 'Up to 12 hours post dose in each period (3 periods)', 'description': 'NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.'}, {'measure': 'Maximum drug concentration time (Tmax) of melatonin', 'timeFrame': 'Up to 12 hours post dose in each period (3 periods)', 'description': 'NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.'}, {'measure': 'Area under the blood concentration time curve (AUC) of melatonin', 'timeFrame': 'Up to 12 hours postdose in each period (3 periods)', 'description': 'NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.'}, {'measure': 'Terminal elimination rate constant (λz) of melatonin', 'timeFrame': 'Up to 12 hours post dose in each period (3 periods)', 'description': 'NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.'}, {'measure': 'Mean residence time (MRT) of melatonin', 'timeFrame': 'Up to 12 hours postdose in each period (3 periods)', 'description': 'NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.'}, {'measure': 'Elimination half-life (t1/2) of melatonin', 'timeFrame': 'Up to 12 hours post dose in each period', 'description': 'NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.'}, {'measure': 'Clearance (CL) of melatonin', 'timeFrame': 'Up to 12 hours post dose in each period (3 periods)', 'description': 'NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.'}, {'measure': 'Volume of distribution (Vd) of melatonin', 'timeFrame': 'Up to 12 hours postdose in each period (3 periods)', 'description': 'NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.'}, {'measure': 'Adverse Events', 'timeFrame': 'Up to 36 hours post dose of Period III', 'description': 'All events that emerge during treatment, having been absent pretreatment, or worsens relative to the pretreatment state'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['QTc prolongation effect'], 'conditions': ['Qt Interval, Variation in']}, 'descriptionModule': {'briefSummary': 'A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)', 'detailedDescription': 'This study is a single center, open label, dose escalation trial to evaluate prolongation effect on QT interval of NPC-15 (melatonin 8mg or 16mg).\n\nThe trial compose of 3 periods; During the each period, eligible volunteers wll be administered placebo, NPC-15 4g (melatonin 8mg) and NPC-15 8g(melatonin 16mg) as a sequential manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject with BMI ≥ 17.6 kg/m2 and \\< 30.0 kg/m2.\n* Subject who falls asleep at between 21:00 and 25:00 and wakes up at between 5:00 and 9:00 during 1 week prior to the first study drug administration.\n* Subject who is able to comply with the study requirements during the study period.\n\nExclusion Criteria:\n\n* Subject with QTcF interval greater than 450 ms in male or greater than 470 ms in female on the 12-lead electrocardiogram (ECG), or with clinically significant ECG abnormalities in other findings.\n* Subject who has a family history of Torsades de Pointes (TdP) or long QT syndrome.\n* Subject who has a history of hypersensitivity or allergies to melatonin or ramelteon.\n* Subject who has a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments.\n* Subject who received any non-prescription or prescription drug within 2 weeks prior to the first study drug administration.\n* Subject who received any product containing St Jones Wart or any supplement containing melatonin within 4 weeks prior to the first study drug administration.\n* Subject who has a history of smoking habit or was possibly exposed to passive smoking on a daily basis within 24 weeks prior to the first study drug administration.\n* Subject who, in the opinion of the investigator or sub-investigator, is unsuitable to be involved in the study.'}, 'identificationModule': {'nctId': 'NCT03475459', 'briefTitle': 'Investigation of Arrhythmogenic Effect of NPC-15 (NPC-15-7)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nobelpharma'}, 'officialTitle': 'A Clinical Pharmacology Study of NPC-15 to Evaluate Arrhythmogenic Effect in Healthy Adults', 'orgStudyIdInfo': {'id': 'NPC-15-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study drug', 'description': 'Study drug (NPC-15 and/or Placebo ) will be orally administered once with 200 ml of water at 20:00 on the first days of Period I, Period II and Period III.', 'interventionNames': ['Drug: NPC-15 and/or Placebo']}], 'interventions': [{'name': 'NPC-15 and/or Placebo', 'type': 'DRUG', 'otherNames': ['Melatonin and/or Placebo'], 'description': 'The dosage and regimen of the study drug in each period is the following. Period I : NPC-15 placebo granules 8 g Period II : NPC-15 placebo granules 4 g + NPC-15 granules 0.2% 4 g (melatonin 8 mg) Period III : NPC-15 granules 0.2% 8 g (melatonin 16 mg)', 'armGroupLabels': ['study drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8120025', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'SOUSEIKAI Hakata Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], 'overallOfficials': [{'name': 'Masaharu Hayashi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shukutoku University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nobelpharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}