Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-25 @ 2:58 PM
Study NCT ID:
NCT04441450
Status:
COMPLETED
Last Update Posted:
2020-06-22
First Post:
2020-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ADME Study of [14C]ICP-022 in Healthy Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-18', 'studyFirstSubmitDate': '2020-06-16', 'studyFirstSubmitQcDate': '2020-06-18', 'lastUpdatePostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution ratio of total radioactivity in whole blood and plasma of [14C]ICP-022', 'timeFrame': 'Up to14 days', 'description': 'To investigate the pharmacokinetics of total radioactivity in plasma after oral \\[14C\\] ICP-022 in healthy volunteers, and the distribution ratio of total radioactivity in whole blood and plasma.'}, {'measure': 'Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers', 'timeFrame': 'Up to14 days', 'description': 'Quantitative analysis of total radioactivity in excreta after oral \\[14C\\] ICP-022 in healthy volunteers, obtaining body material balance data and main excretion pathways'}], 'secondaryOutcomes': [{'measure': 'Quantitative analysis of the concentration of ICP-022 in plasma', 'timeFrame': 'Up to14 days', 'description': 'Quantitative analysis of the concentration of ICP-022 in plasma to obtain the pharmacokinetic parameters of ICP-022'}, {'measure': 'The biotransformation pathways of [14C]ICP-022', 'timeFrame': 'Up to14 days', 'description': 'Urine and fecal collection for metabolite profiling. Identify the main metabolites in humans after oral \\[14\\]ICP-022 in healthy volunteers to determine the main biotransformation pathways.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the absorption, the metabolic pathways and the excretion of ICP-022 in healthy male adult participants after administration of a single oral dose of 150 mg of 14C ICP-022.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'key Inclusion criteria:\n\n1. Weight: Body mass index (BMI) is 19\\~26 kg/m2\n2. signing of informed consent\n3. Volunteers are able to communicate well with the investigators and be able to complete the trial according to the process\n\nKey Exclusion Criteria:\n\n1. physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, blood coagulation routine, urine routine, stool routine + occult blood, serum amylase, thyroid function, etc.), 12-lead ECG, Chest X-ray (Anteroposterior), abdominal B-ultrasound (hepatobiliary, pancreas, spleen and kidney) and other abnormalities and clinical significance.\n2. ophthalmologic examination shows abnormality and clinical significance\n3. Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, positive test for Syphilis antibody.\n4. Within 1 month before the screening, having not limited to known as hepatic enzyme inducers, inhibitors or substrates; (eg, inducer - barbiturate, carbamazepine, phenytoin, rifampicin, dexamethasone, rifabutin, rifapentine; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, verapamil, imidazole antifungals) ;\n5. Within 1 month before the screening, receiving the anticoagulant therapy such as warfarin or thrombin inhibitor and/or aspirin antiplatelet therapy\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04441450', 'briefTitle': 'ADME Study of [14C]ICP-022 in Healthy Males', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing InnoCare Pharma Tech Co., Ltd.'}, 'officialTitle': 'Absorption, Metabolism, and Excretion of Oral 14C Radiolabeled ICP-022: An Open-Label, Phase I, Single-Dose Study in Healthy Males', 'orgStudyIdInfo': {'id': 'ICP-CL-00110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]ICP-022', 'description': 'Subjects will take a single of 150mg 100μCi of \\[14C\\]ICP-022.', 'interventionNames': ['Drug: [14C]ICP-022']}], 'interventions': [{'name': '[14C]ICP-022', 'type': 'DRUG', 'description': '150mg suspension containing 100μCi of \\[14C\\]ICP-022', 'armGroupLabels': ['[14C]ICP-022']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing InnoCare Pharma Tech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}