Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT04477369
Status:
UNKNOWN
Last Update Posted:
2020-07-29
First Post:
2020-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of DWJ1439, DWJ1464, DWC202003 or DWC202004 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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Area under the plasma concentration-time curve from time 0 to time t'}, {'measure': 'PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Maximum plasma drug concentration'}, {'measure': 'PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUC0-t', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Area under the plasma concentration-time curve from time 0 to time t'}, {'measure': 'PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cmax', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Maximum plasma drug concentration'}], 'secondaryOutcomes': [{'measure': 'PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUCinf', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Area under the plasma concentration-time curve from drug administration to drug elimination'}, {'measure': 'PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Time to reach maximum plasma concentration following drug administration'}, {'measure': 'PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: t1/2', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Elimination half-life'}, {'measure': 'PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: , Cl/F', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Apparent total clearance of drug from plasma after oral administration'}, {'measure': 'PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Apparent volume of distribution after oral administration'}, {'measure': 'PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUCinf', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Area under the plasma concentration-time curve from drug administration to drug elimination'}, {'measure': 'PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Tmax', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Time to reach maximum plasma concentration following drug administration'}, {'measure': 'PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: t1/2', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Elimination half-life'}, {'measure': 'PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cl/F', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Apparent total clearance of drug from plasma after oral administration'}, {'measure': 'PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Vd/F', 'timeFrame': '0 - 72 hours after dosing', 'description': 'Apparent volume of distribution after oral administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults.', 'detailedDescription': 'The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult volunteers aged 19 years old to under 55.\n* BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg\n* Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination.\n* Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG).\n* Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.\n\nExclusion Criteria:\n\n* Known history or presence of any clinically significant medical condition.\n* Participation in a clinical drug study or bioequivalence study 6 months prior to the present study.\n* Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period.\n* Refusal to abstain from alcohol, caffeine, or other xanthines, or grapefruit containing food or drinks for 72 hours before drug administration and during each study period.\n* Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.'}, 'identificationModule': {'nctId': 'NCT04477369', 'briefTitle': 'Safety and Pharmacokinetics of DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'An Exploratory Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'DW_DWJ1464101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sequence A', 'description': '7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3.', 'interventionNames': ['Drug: DWJ1439', 'Drug: DWJ1464', 'Drug: DWC202003']}, {'type': 'OTHER', 'label': 'Sequence B', 'description': '7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3.', 'interventionNames': ['Drug: DWJ1464', 'Drug: DWC202003', 'Drug: DWC202004']}, {'type': 'OTHER', 'label': 'Sequence C', 'description': '7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3.', 'interventionNames': ['Drug: DWJ1439', 'Drug: DWC202003', 'Drug: DWC202004']}, {'type': 'OTHER', 'label': 'Sequence D', 'description': '7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3.', 'interventionNames': ['Drug: DWJ1439', 'Drug: DWJ1464', 'Drug: DWC202004']}], 'interventions': [{'name': 'DWJ1439', 'type': 'DRUG', 'description': '300mg single dose', 'armGroupLabels': ['Sequence A', 'Sequence C', 'Sequence D']}, {'name': 'DWJ1464', 'type': 'DRUG', 'description': '300mg single dose', 'armGroupLabels': ['Sequence A', 'Sequence B', 'Sequence D']}, {'name': 'DWC202003', 'type': 'DRUG', 'description': '300mg single dose', 'armGroupLabels': ['Sequence A', 'Sequence B', 'Sequence C']}, {'name': 'DWC202004', 'type': 'DRUG', 'description': '300mg single dose', 'armGroupLabels': ['Sequence B', 'Sequence C', 'Sequence D']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bo-Hyung Kim', 'role': 'CONTACT'}], 'facility': 'Kyung Hee University Medical Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Bo-Hyung Kim', 'role': 'CONTACT', 'email': 'bhkim98@gmail.com', 'phone': '+82-2-958-9326'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}