Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-24 @ 9:32 PM
Study NCT ID:
NCT02289404
Status:
COMPLETED
Last Update Posted:
2019-03-08
First Post:
2014-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-06', 'studyFirstSubmitDate': '2014-11-09', 'studyFirstSubmitQcDate': '2014-11-09', 'lastUpdatePostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics : Cmax', 'timeFrame': '0-24 hours', 'description': 'Maximum plasma concentration'}, {'measure': 'Pharmacokinetics : AUCt', 'timeFrame': '0-24 hours', 'description': 'Area under the concentration-time curve'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics : AUCinf', 'timeFrame': '0-24 hours', 'description': 'AUC extrapolated to infinity'}, {'measure': 'Pharmacokinetics : Tmax', 'timeFrame': '0-24 hours', 'description': 'Time to reach the Cmax'}, {'measure': 'Pharmacokinetics : t1/2', 'timeFrame': '0-24 hours', 'description': 'Terminal elimination half-life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate food effect on the pharmacokinetics of NVP-1203', 'detailedDescription': 'This study is designed as randomized, open-label, crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1203 in healthy adult subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthy adult subjects who signed informed consent\n\nExclusion Criteria:\n\n* Subjects has a history of allergy reaction of study drug ingredient\n* Subjects participated in another clinical trial within 3 months prior to administration of the study drug\n* Inadequate subject for the clinical trial by the investigator's decision"}, 'identificationModule': {'nctId': 'NCT02289404', 'acronym': 'NVP-1203', 'briefTitle': 'A Study to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203', 'organization': {'class': 'INDUSTRY', 'fullName': 'NVP Healthcare'}, 'officialTitle': 'Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'NVP-1203_FE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NVP-1203(fed then fasting)', 'description': 'Subjects will receive a oral dose of NVP-1203 under fed conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fasting conditions in period 2', 'interventionNames': ['Drug: NVP-1203']}, {'type': 'EXPERIMENTAL', 'label': 'NVP-1203(fasting then fed)', 'description': 'Subjects will receive a oral dose of NVP-1203 under fasting conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fed conditions in period 2', 'interventionNames': ['Drug: NVP-1203']}], 'interventions': [{'name': 'NVP-1203', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['NVP-1203(fed then fasting)']}, {'name': 'NVP-1203', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['NVP-1203(fasting then fed)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700-721', 'city': 'Daegu', 'state': 'Dongdeok-ro', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Yoon Y Ran, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NVP Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}