Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT05407220
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2022-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male 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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2022-06-02', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of Losartan', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'AUC last of Losartan', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'AUC inf of Losartan', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Tmax of Losartan', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 't1/2 of Losartan', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'CL/F of Losartan', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Vd/F of Losartan', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Cmax of EXP3174', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'AUC last of EXP3174', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'AUC inf of EXP3174', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Tmax of EXP3174', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 't1/2 of EXP3174', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'CL/F of EXP3174', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Vd/F of EXP3174', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Cmax of Chlorthalidone', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'AUC last of Chlorthalidone', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'AUC inf of Chlorthalidone', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Tmax of Chlorthalidone', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 't1/2 of Chlorthalidone', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'CL/F of Chlorthalidone', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Vd/F of Chlorthalidone', 'timeFrame': 'Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours', 'description': 'pharmacokinetic evaluation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 19\\~45 years in healthy male volunteers\n2. Weight ≥ 55kg and BMI 18 \\~ 30 kg/m\\^2\n3. Subjects who agree to use medically accepted dual contraceptives up to 14 days after the last administration date of the clinical trial drug and not to provide sperm.\n4. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing\n\nExclusion Criteria:\n\n1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system\n2. Subjects who judged ineligible by the investigator'}, 'identificationModule': {'nctId': 'NCT05407220', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.', 'orgStudyIdInfo': {'id': 'HM-CHORUS-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group1', 'description': 'Period1: HCP1904-1', 'interventionNames': ['Drug: HCP1904-1']}, {'type': 'EXPERIMENTAL', 'label': 'group2', 'description': 'Period1: HCP1904-3', 'interventionNames': ['Drug: HCP1904-3']}], 'interventions': [{'name': 'HCP1904-1', 'type': 'DRUG', 'description': 'take it once per period', 'armGroupLabels': ['group1']}, {'name': 'HCP1904-3', 'type': 'DRUG', 'description': 'take it once per period', 'armGroupLabels': ['group2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yangji Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}