Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-30 @ 6:55 PM
Study NCT ID:
NCT05490095
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2022-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Crossover of SVG101(Dispersible Tab. of Everolimus) and Afinitor 5mg in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-03', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCinf of everolimus', 'timeFrame': 'up to 144 hours'}, {'measure': 'Cmax of Everolimus', 'timeFrame': 'up to 144 hours'}, {'measure': 'Cmin,ss,pred of Everolimus', 'timeFrame': 'up to 144 hours'}, {'measure': 'AUClast of Everolimus', 'timeFrame': 'up to 144 hours'}, {'measure': 'Tmax of Everolimus', 'timeFrame': 'up to 144 hours'}, {'measure': 't1/2 of Everolimus', 'timeFrame': 'up to 144 hours'}, {'measure': 'Vd/F of Everolimus', 'timeFrame': 'up to 144 hours'}, {'measure': 'Clearance of Everolimus', 'timeFrame': 'up to 144 hours'}], 'secondaryOutcomes': [{'measure': 'Adverse Events (AEs)', 'timeFrame': 'up to approximately 45 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Everolimus', 'Healthy adults', 'Disperse formulation'], 'conditions': ['Pharmacokinetics']}, 'referencesModule': {'references': [{'pmid': '25799227', 'type': 'BACKGROUND', 'citation': 'Lim JS, Kim WI, Kang HC, Kim SH, Park AH, Park EK, Cho YW, Kim S, Kim HM, Kim JA, Kim J, Rhee H, Kang SG, Kim HD, Kim D, Kim DS, Lee JH. Brain somatic mutations in MTOR cause focal cortical dysplasia type II leading to intractable epilepsy. Nat Med. 2015 Apr;21(4):395-400. doi: 10.1038/nm.3824. Epub 2015 Mar 23.'}], 'seeAlsoLinks': [{'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203985Orig1s000ClinPharmR.pdf', 'label': 'Everolimus\\_Clinical Pharmacology Review'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the pharmacokinetics and safety of SVG101 (dispersible tab. of everolimus) in healthy volunteers compared to Afinitor tab. after oral administration.', 'detailedDescription': 'This is a randomized, open-label, single-dose, two-way cross-over study to investigate the Pharmacokinetic characteristics and safety after oral administration of SVG101 (dispersible tablet of everolimus) 5mg and Afinitor 5mg in 26 healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adults: 19y - 55y (Male or Female)\n2. Male: more than 55kg, Female: more than 50kg body weight\n3. Body mass index: more than 18.5kg/m\\^2 and less than 27.0kg/m\\^2\n4. Menopause or surgical infertility female\n\nExclusion Criteria:\n\n1. Participants have or had a history of the clinically relevant disease or abnormalities in the hepatobiliary system, kidney, nervous system, immune system, respiratory system, urinary system, digestive system, endocrine system, blood/tumor, cardiovascular system, and mental illness.\n2. Participants with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n3. Any history of gastrointestinal disease or surgery\n4. Participants have hypersensitive to the everolimus or other rapamycin derivatives or other components of the investigational product.\n5. Taking any drugs that induce or inhibit metabolizing enzymes such as barbiturate drugs within 30 days prior to first administration\n6. Receiving any investigational therapy of others within 180 days prior to first administration. In case of biological products, the restricted period can be extended depend on the half-life receipt product\n7. Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT05490095', 'briefTitle': 'Randomized Crossover of SVG101(Dispersible Tab. of Everolimus) and Afinitor 5mg in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'SoVarGen Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetic and Safety After Oral Administration of SVG101(Dispersible Tablet of Everolimus) 5mg and Afinitor 5mg in Healthy Adults', 'orgStudyIdInfo': {'id': 'SVG101-P1-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': '13 subjects will receive\n\n1. First Dose: Afinitor 5mg, single dose\n2. Wash out period : more than 10 days\n3. Second Dose: SVG101 5mg, single dose', 'interventionNames': ['Drug: SVG101 (T)', 'Drug: Afinitor (R)']}, {'type': 'EXPERIMENTAL', 'label': 'Group II', 'description': '13 subjects will receive\n\n1. First Dose: SVG101 5mg, single dose\n2. Wash out period : more than 10 days\n3. Second Dose: Afinitor 5mg, single dose', 'interventionNames': ['Drug: SVG101 (T)', 'Drug: Afinitor (R)']}], 'interventions': [{'name': 'SVG101 (T)', 'type': 'DRUG', 'description': '5mg of SVG101', 'armGroupLabels': ['Group I', 'Group II']}, {'name': 'Afinitor (R)', 'type': 'DRUG', 'description': '5mg of Afinitor', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Healthcare System, Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Eric J Maeng', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SoVarGen Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SoVarGen Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}