Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04782505
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2021-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics Evaluation Study According to the Dose of Camostat Mesylate in Healthy Volunteers
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', 'interventionModelDescription': 'Part1. Parallel, Part2. Crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-02', 'studyFirstSubmitDate': '2021-03-01', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of GBPA', 'timeFrame': '0-6 hr', 'description': 'Maximum blood concentration of GBPA (GUANIDINO BENZOYLOXY PHENYLACETIC ACID METHANESULFONATE) among observed blood concentrations at time points\n\n* Immediately before administration of IP\n* After administration'}, {'measure': 'AUClast of GBPA', 'timeFrame': '0-6 hr', 'description': 'Area under the blood concentration-time of GBPA (GUANIDINO BENZOYLOXY PHENYLACETIC ACID METHANESULFONATE) among observed blood concentrations at time points\n\n* Immediately before administration of IP\n* After administration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Safety and pharmacokinetics evaluation study according to the dose of camostat mesylate in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adults aged ≥ 19 and ≤ 55 years at screening\n* Subjects with body weight of ≥ 55.0 kg and ≤ 90.0 kg, and a body mass index (BMI) of ≥ 18.0 and ≤ 29.9\n* Subjects who have no congenital or chronic disease and have no pathological symptoms or findings as a result of an internal examination\n\nExclusion Criteria:\n\n* Subjects with current or prior history of a clinically significant hepatic, renal, nervous, respiratory, gastrointestinal, endocrine, hematologic and oncologic, urogenital, cardiovascular, musculoskeletal or psychiatric disorder\n* Subjects with symptoms of acute disease within 28 days prior to the scheduled first administration date of IP\n* Subjects with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcers, etc.) or gastrointestinal resection (except simple appendectomy or hernia surgery) that may affect the absorption of drugs."}, 'identificationModule': {'nctId': 'NCT04782505', 'briefTitle': 'Safety and Pharmacokinetics Evaluation Study According to the Dose of Camostat Mesylate in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Open-label, Single-dose, Phase 1 Study to Compare and Evaluate the Safety and Pharmacokinetics According to the Dose of Camostat Mesylate in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'DW_DWJ1248101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 (Part 1)', 'description': 'DWJ1248 100mg (100mg 1tab) PO', 'interventionNames': ['Drug: DWJ1248']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 (Part 1)', 'description': 'DWJ1248 200mg (100mg 2tab) PO', 'interventionNames': ['Drug: DWJ1248']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 (Part 1)', 'description': 'DWJ1248 300mg (100mg 3tab) PO', 'interventionNames': ['Drug: DWJ1248']}, {'type': 'EXPERIMENTAL', 'label': 'Group A (Part 2)', 'description': 'DWJ1248 100mg 2tab PO - Wash out - DWJ1248 200mg 1tab PO', 'interventionNames': ['Drug: DWJ1248']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (Part 2)', 'description': 'DWJ1248 200mg 1tab PO - Wash out - DWJ1248 100mg 2tab PO', 'interventionNames': ['Drug: DWJ1248']}], 'interventions': [{'name': 'DWJ1248', 'type': 'DRUG', 'description': 'Camostat mesylate Tablet from Daewoong', 'armGroupLabels': ['Cohort 1 (Part 1)', 'Cohort 2 (Part 1)', 'Cohort 3 (Part 1)', 'Group A (Part 2)', 'Group B (Part 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35015', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}