Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-02-18 @ 10:16 AM
Study NCT ID:
NCT03864432
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2019-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C534891', 'term': 'LC15-0444'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-01', 'studyFirstSubmitDate': '2019-03-04', 'studyFirstSubmitQcDate': '2019-03-04', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast of Gemigliptin', 'timeFrame': '0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h'}, {'measure': 'Cmax of Gemigliptin', 'timeFrame': '0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of Gemigliptin and Food effect in healthy Chinese subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male and female subjects (aged 19\\~45 years at the time of screening)\n* Subjects weighing between 50kg (inclusive) and 90kg (exclusive), and having a body mass index (BMI) of 17.1～25.8 (inclusive of limits).\n* Subjects with a fasting plasma glucose (FPG) of 70～110mg/dL (inclusive of limits) at the time of screening\n* Subjects who are willing to participate in the entire study cycle and comply with the study protocol (including contraception). Subjects who can sign the written Informed Consent Form after being informed of the study procedures.\n\nExclusion Criteria:\n\n* Those with a history of allergies including drug allergies (aspirin, antibiotics, etc.), or other clinically significant allergies.\n* Those with diseases of the liver (including carriers of hepatitis virus), kidney, respiratory system, endocrine system, nervous system or immune system. Those with a medical history of hematology/oncology, psychiatry or cardiovascular diseases.\n* Those with a medical history of gastrointestinal diseases (ulcers, Crohn's disease, etc.) or surgery (excluding simple appendectomy or hernia repair), and these situations can affect the absorption of the study drug."}, 'identificationModule': {'nctId': 'NCT03864432', 'briefTitle': 'An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Chem'}, 'officialTitle': 'An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)', 'orgStudyIdInfo': {'id': 'LG-DPCL020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '25mg SAD', 'interventionNames': ['Drug: Gemigliptin 25mg']}, {'type': 'EXPERIMENTAL', 'label': '50mg SAD', 'interventionNames': ['Drug: Gemigliptin 50mg']}, {'type': 'EXPERIMENTAL', 'label': '100mg SAD', 'interventionNames': ['Drug: Gemigliptin 100mg']}, {'type': 'EXPERIMENTAL', 'label': '50mg Multiple dosing', 'interventionNames': ['Drug: Gemiglptin 50mg multiple dose']}], 'interventions': [{'name': 'Gemigliptin 25mg', 'type': 'DRUG', 'description': 'Gemigliptin 50mg 1/2T', 'armGroupLabels': ['25mg SAD']}, {'name': 'Gemigliptin 50mg', 'type': 'DRUG', 'description': 'Gemigliptin 50mg 1T', 'armGroupLabels': ['50mg SAD']}, {'name': 'Gemigliptin 100mg', 'type': 'DRUG', 'description': 'Gemigliptin 50mg 2T', 'armGroupLabels': ['100mg SAD']}, {'name': 'Gemiglptin 50mg multiple dose', 'type': 'DRUG', 'description': 'Gemigliptin 50mg 1T \\* 10days', 'armGroupLabels': ['50mg Multiple dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200002', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Xuhui Central hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Yan-Mei Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Xuhui District Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Chem', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}