Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT03977805
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2019-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolism and Disposition of [14C] Herombopag in Chinese Healthy Human 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': '2019-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2019-05-05', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total radioactivity pharmacokinetics in whole blood and plasma', 'timeFrame': 'From 1 hour before administration to 240 hours after administration', 'description': 'plasma concentration of total radioactivity'}, {'measure': 'total radioactivity in the excreta', 'timeFrame': 'From 24 hour before administration to 336 hours after administration', 'description': 'Excretion of radioactivity in human urine and feces'}, {'measure': 'the concentration of Hetrombopag in plasma', 'timeFrame': 'From 1 hour before administration to 240 hours after administration', 'description': 'Area under the plasma concentration versus time curve (AUC)'}, {'measure': 'individual metabolite profiles in plasma 、urine and faces', 'timeFrame': 'From 24 hour before administration to 336 hours after administration', 'description': 'Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse individual percentage of metabolites.'}, {'measure': 'mean metabolite profiles in plasma 、urine and faces', 'timeFrame': 'From 24 hour before administration to 336 hours after administration', 'description': 'Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse mean percentage of metabolites.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is a single-center, open-label, single-dose design. It is planning to enroll six Chinese healthy adult male subjects. The metabolism and disposition of Herombopag, will be studied in these subjects after a single oral administration of a solution dose of \\[14C\\] Herombopag (5 mg, 100 uCi).', 'detailedDescription': 'The metabolism and disposition of Herombopag, will be studied in six healthy men after a single oral administration of a solution dose of \\[14C\\]eltrombopag (5 mg,100 uCi).\n\nThe sutdy will investigate total radioactivity pharmacokinetics in whole blood and plasma 、quantitatively analyze the the total radioactivity in the excreta、evaluate the predominant route of elimination and indentify the Metabolite profiles in plasma 、urine and faces.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health male subjects, age between 18-45 years.\n* BMI between 19 and 26 kg/m2 .\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Abnormal results in physical examination、laboratory tests、X-ray、abdominal ultrasound、echocardiography have clinical significance.\n* Abnormal platelet counts or platelet aggregation has clinical significance.\n* Abnormal troponin examination has clinical significance.\n* Abnormal ophthalmic examination has clinical significance.\n* Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody is positive.\n* Those who have a history of allergies to test drugs or similar drugs.\n* Those who have undergone surgery within 6 months prior to the trial .\n* Those who took any drug within 14 days before the test (including Chinese herbal medicine).\n* Any drug that inhibits or induces liver drug metabolism within 30 days before the test.\n* Subjects who have participated in other clinical trial within the 3 months prior to study entry.\n* One or more non-pharmacological contraceptive measures cannot be used during the trial or it is planned to have birth within one year.'}, 'identificationModule': {'nctId': 'NCT03977805', 'briefTitle': 'Metabolism and Disposition of [14C] Herombopag in Chinese Healthy Human Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Metabolism and Disposition of [14C] Herombopag in Chinese Healthy Human Subjects', 'orgStudyIdInfo': {'id': 'HR-TPO-Ih'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hetrombopag Olamine', 'description': 'Hetrombopag Olamine (5 mg, 100 uCi)', 'interventionNames': ['Drug: Hetrombopag Olamine']}], 'interventions': [{'name': 'Hetrombopag Olamine', 'type': 'DRUG', 'description': 'a single oral taking', 'armGroupLabels': ['Hetrombopag Olamine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The first affiliated hospital of Suzhou university', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'overallOfficials': [{'name': 'Liyan Miao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Suzhou Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}