Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-23 @ 8:24 PM
Study NCT ID:
NCT03627520
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2018-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Sulfatinib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000717729', 'term': 'surufatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open label'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is single centre, open label, single dose study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-22', 'studyFirstSubmitDate': '2018-03-13', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of total radioactivity of [14C] Sulfatinib', 'timeFrame': 'Measured from the 0 hour to 216 hours', 'description': 'The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.'}], 'secondaryOutcomes': [{'measure': 'To investigate the Maximum observed plasma concentration (Cmax) of total radioactivity of [14C] Sulfatinib', 'timeFrame': 'Measured from the 0 hour to 216 hours', 'description': 'Maximum observed concentration, occurring at Tmax.'}, {'measure': 'To investigate the time to Cmax (peak time, Tmax) of total radioactivity of [14C] Sulfatinib', 'timeFrame': 'Measured from the 0 hour to 216 hours', 'description': 'The time at which maximum plasma concentration (Cmax) is observed.'}, {'measure': 'To investigate Half-life (t1/2) of total radioactivity of [14C] Sulfatinib', 'timeFrame': 'Measured from the 0 hour to 216 hours', 'description': 'The time at which Half-life (t1/2) is observed.'}, {'measure': 'To obtain mass balance data after a single oral dose of [14C] Sulfatinib', 'timeFrame': 'Measured on the Day1 to Day15', 'description': 'Quantitative analysis of total radioactivity in the excretion of Sulfatinib'}, {'measure': 'To observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib.', 'timeFrame': 'Measured from the date signed ICF to within 15 days after the single dose', 'description': 'Adverse Event (AE) monitoring of \\[14C\\] Sulfatinib'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a single-center, open label and single-dose clinical trail, to explore the body mass balance and identify the major metabolites in Chinese adult male healthy volunteers after a single oral dose of \\[14C\\]Sulfatinib, to obtain the pharmacokinetic parameters of plasma and observe the safety of healthy volunteers after a single oral dose of \\[14C\\]Sulfatinib.', 'detailedDescription': 'In order to determine the optimal time point for sample collection, this study will be divided into two stages: the first stage, two volunteers will be enrolled, the volunteers should stop collecting the corresponding samples by the investigators based on radioactive test results, safety results combined with the actual comprehensive situation. And in the second stage sample collection time for another four volunteers will be determined and adjusted according to the results of the first stage.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Age of 18-50 (inclusive), Male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of written Informed Consent Form (ICF)\n2. Age of 18-50 (inclusive)；\n3. Body weight over 50 kg and body mass index (BMI) between 19-26 kg / m2 (inclusive)；\n\nExclusion Criteria:\n\n1. Laboratory tests (blood tests, blood biochemical tests \\[fasting\\], coagulation tests, thyroid function tests, urinalysis, fecal occult blood) judged as clinically significant abnormal by investigators；\n2. Clinically significant abnormal ECG at screening and before screening；\n3. Hepatitis B surface antigen (HBsAg), e antigen (HBeAg) or hepatitis C antibody (HCV Ab) test positive；\n4. Human immunodeficiency virus (HIV) antibody positive；\n5. Treponema pallidum antibody positive.'}, 'identificationModule': {'nctId': 'NCT03627520', 'briefTitle': 'A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Sulfatinib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hutchmed'}, 'officialTitle': 'Single-center, Open and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 300 mg /100 μCi [14C] Sulfatinib in Chinese Adult Male Healthy Volunteers', 'orgStudyIdInfo': {'id': '2017-012-00CH1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '[14C]Sulfatinib', 'description': 'This is a single center and single dose in 6 volunteers. Subject would take a suspension containing 300 mg of Sulfatinib (containing about 100 μCi of radioactivity) within 1 hour after standard breakfast.', 'interventionNames': ['Drug: [14C]Sulfatinib']}], 'interventions': [{'name': '[14C]Sulfatinib', 'type': 'DRUG', 'otherNames': ['300 mg /100 μCi [14C] Sulfatinib, Sulfatinib, HMPL-012, Surufatinib'], 'description': '300 mg Sulfatinib with 100 µCi \\[14C\\]', 'armGroupLabels': ['[14C]Sulfatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201203', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Hutchison Medipharma Ltd.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Ke LI, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hutchison Medipharma Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hutchison Medipharma Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}