Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 1:46 AM
Study NCT ID:
NCT05446233
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2022-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution ratio of total radioactivity in whole blood and plasma of [14C] Antaitavir Hasophate', 'timeFrame': 'up to 15 days', 'description': 'To investigate the pharmacokinetics of total radioactivity in plasma after oral \\[14C\\] Antaitavir Hasophate in healthy subjects, and the distribution ratio of total radioactivity in whole blood and plasma'}, {'measure': 'Cumulative excretion of [14C] Antaitavir Hasophate -related material (radioactivity in plasma, urine and fecal samples)', 'timeFrame': 'up to 15 days', 'description': 'Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.'}], 'secondaryOutcomes': [{'measure': 'Identification of the Proportion of different metabolites to determine biotransformation pathway of Antaitavir Hasophate', 'timeFrame': 'up to 15 days', 'description': 'Proportion of different metabolites(Antaitavir Hasophate and main metabolites）'}, {'measure': 'Quantitive analysis of the concentrations of Antaitavir Hasophate and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data', 'timeFrame': 'up to 15 days', 'description': 'The concentrations of Antaitavir Hasophate and main metabolites in plasma'}, {'measure': 'Number of adverse events (AE) experienced by subjects', 'timeFrame': 'up to 15 days', 'description': 'To examine the safety and tolerability of \\[14C\\] Antaitavir Hasophate given orally'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Male Subjects']}, 'descriptionModule': {'briefSummary': 'This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \\[14C\\] Antaitavir Hasophate.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signing of informed consent\n* Weight: Body mass index (BMI) is 19.0\\~28.0 kg/m2\n* Subjects are able to communicate well with the investigators and be able to complete the trial according to the process\n\nExclusion Criteria:\n\n* Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations\n* Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive\n* Positive results from urine drug screen test\n* Donate blood or lose blood 400 mL or more within 3 month prior to dosing\n* Subjects who have used any medication, biological product, Chinese patent medicine, herbal medicine, nutritional supplements or health care products within 14 days prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication\n* History of needles or blood fainting, or have difficulty in blood collection or cannot tolerate venipuncture for blood collection'}, 'identificationModule': {'nctId': 'NCT05446233', 'briefTitle': 'ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sunshine Lake Pharma Co., Ltd.'}, 'officialTitle': 'Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] Antaitavir Hasophate in Healthy Male Participants', 'orgStudyIdInfo': {'id': 'HEC74647-P-04/CRC-C2222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C] Antaitavir Hasophate', 'description': 'Eligible healthy male subjects received a single oral 100 mg (radioactivity of 200µCi) dose of \\[14C\\] Antaitavir Hasophate', 'interventionNames': ['Drug: [14C] Antaitavir Hasophate']}], 'interventions': [{'name': '[14C] Antaitavir Hasophate', 'type': 'DRUG', 'description': '100 mg suspension containing 200µCi of \\[14C\\] Antaitavir Hasophate', 'armGroupLabels': ['[14C] Antaitavir Hasophate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai xuhui central hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunshine Lake Pharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}