Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-27 @ 3:09 AM
Study NCT ID:
NCT05677035
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2022-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LINO-1713 in Healthy Korean Female Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2023-01-05', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics parameters: Cmax', 'timeFrame': 'Before and after administration 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, and 168 hours'}, {'measure': 'Pharmacokinetics parameters: Tmax', 'timeFrame': 'Before and after administration 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, and 168 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'A single-center, open-label, parallel-group, phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of LINO-1713 in healthy Korean female subjects'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with a Body Mass Index (BMI) between 18kg/m2 \\~ 28kg/m2\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular disease, respiratory disease'}, 'identificationModule': {'nctId': 'NCT05677035', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LINO-1713 in Healthy Korean Female Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hyundai Pharm'}, 'officialTitle': 'A Single-center, Open-label, Parallel-group, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LINO-1713 in Healthy Korean Female Subjects', 'orgStudyIdInfo': {'id': 'HT-014-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pharmacokinetic evaluation', 'description': 'LINO-1713 (Estetrol 15mg/Drospirenone 3mg)', 'interventionNames': ['Drug: LINO-1713 1 tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Pharmacodynamic evaluation', 'description': 'LINO-1713 (Estetrol 15mg/Drospirenone 3mg)', 'interventionNames': ['Drug: LINO-1713 once a day for 24 days']}], 'interventions': [{'name': 'LINO-1713 1 tablet', 'type': 'DRUG', 'description': 'LINO-1713 1 tablet is administered once. Oral administration with 200mL of water', 'armGroupLabels': ['Pharmacokinetic evaluation']}, {'name': 'LINO-1713 once a day for 24 days', 'type': 'DRUG', 'description': 'Oral administration is performed with 200 mL of water. Instruct subjects to take the drug at the same time as possible.', 'armGroupLabels': ['Pharmacodynamic evaluation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hyundai Pharm', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}