Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-29 @ 3:49 PM
Study NCT ID:
NCT04810533
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2021-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000728623', 'term': 'SH-1028'}]}}, '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': '2020-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2021-03-17', 'studyFirstSubmitQcDate': '2021-03-18', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of radioactive dose of [14C] radiolabelled SH-1028 recovered in blood and in total, up to Day 15', 'timeFrame': 'Blood samples : - 0.5hrs, 1hrs, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 120hrs, 168hrs, 216hrs, 264hrs and 336hrs', 'description': 'The distribution of \\[14C\\]SH-1028 in the whole blood and plasma and whole radioactive pharmacokinetics following the single orally administered \\[14C\\]SH-1028 in healthy male volunteers.'}, {'measure': 'The percentage of radioactive dose of [14C] radiolabelled SH-1028 recovered in urine, faeces and in total, up to Day 15.', 'timeFrame': 'Day1 to Day 15', 'description': 'Quantitive analysis of whole radioactivity of excrement of orally administered \\[14C\\]SH-1028 in healthy volunteers to obtain the mass balance data and the main excretion pathway in human body.'}, {'measure': 'The concentrations of SH-1028, Imp2 and Imp3 in plasma up to Day 15', 'timeFrame': 'Blood samples : - 0.5hrs, 1hrs, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 120hrs, 168hrs, 216hrs, 264hrs and 336hrs', 'description': 'Quantitive analysis of the concentrations of SH-1028 and Imp2,Imp3 (Metabolites of SH-1028) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.'}, {'measure': 'Proportion of different metabolites', 'timeFrame': 'Blood samples : - 0.5hrs, 1hrs, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 120hrs, 168hrs, 216hrs, 264hrs and 336hrs', 'description': 'Proportion of different metabolites in healthy volunteers after oral administration of \\[14C\\]SH-1028'}, {'measure': 'Types of adverse events', 'timeFrame': 'Baseline (Day-2) to Day 15', 'description': 'Types of adverse events assessed by CTCAE v5.0 that occurred during the trial'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Male Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of \\[14C\\] SH-1028 in healthy Chinese male subjects. The study will be conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the collection time of plasma, urine and feces sampling post-dose. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 2-4 subjects will be adjusted according to the pilot study.', 'detailedDescription': 'Subjects who had signed informed consent and meet inclusion criteria and no exclusion criteria are admitted to Phase I Clinical Unit two days prior to dosing (D-2). On the morning of Day 1 before dosing, subjects will be transferred to nuclear medical ward. And after an overnight fast of at least 10 h, subjects will receive a single oral dose of 200 mg (88 μCi) of \\[14C\\]SH-1028 as an oral suspension. Then, after two days of the dosing, subjects will be transferred back to Phase I Clinical Unit ward and confined to this unit until blood or excreta sampling and safety monitoring at the designated time points or intervals are complete.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male volunteers between the age of 18 to 50 years old；\n2. Body weight \\>=50 kg, Body mass index between 19 and 26 kg/m2 (including 19 and 26 kg/m2);\n3. Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant;\n4. Male subjects of reproductive potential with partners will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 6 months after discontinuing treatment with the investigational product.;\n5. Signing the informed consent forms by oneself;\n6. Be able to communicate well with the researcher and be able to complete the trial in accordance with the program.\n\nExclusion Criteria:\n\n1. History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;\n2. Positive test for HBs-Ag, HCV-Ab, HIV-Ab, or syphilis antibody;\n3. Long-QT syndrome or family history of it, or QTcF interval \\> 450 mses;\n4. Allergies, have allergies to drugs or foods; or have known allergies to the components of the drug;\n5. Those who smoked daily \\>5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study；\n6. The weekly alcohol consumption was higher than 14 units of alcohol (1 unit=10ml or 8g absolute alcohol. 25 ml 40% liquor, 330ml 5% beers, 175ml 12% grape wine are equal to 1.0, 1.5 and 2.0 units of alcohol respectively) 3 months prior to screening period, or positive test for the alcohol breath test results during screening period；\n7. Those have history of drug abuse or taking soft drug (i.e., marihuana); or the results of urine test in drugs were positive;\n8. Participated in other clinical trials within 3 months before screening;\n9. Received any drug within 14 days before taking the investigational drug;\n10. Received any drugs that inhibit or induce the CYP450 enzyme (i.e., inducers- barbiturates, tegretol, phenytoin, rifampicin, hexadecadrol, rifabutin, rifapentini; inhibitors- SSRI-antidepressant, cimetidine, diltiazem, macrolides, verapamil, imidazoles- antifungal drugs) 30 days prior to screening period；\n11. History of syncope / needle syncope and intolerable intravenous indwelling needle;\n12. Those who have undergone major surgery within the first 6 months of the screening period;\n13. Those who have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease；\n14. Hemorrhoids or perianal disease with regular/perianal bleeding;\n15. Significant radiation exposure within one year prior to drug administration (more than one exposure from chest X-ray, CT scan, or barium meal examination and radiation-related occupations);\n16. Those who cannot complete this study because of other reasons, or any factors judged by investigator that the participants cannot meet.'}, 'identificationModule': {'nctId': 'NCT04810533', 'briefTitle': 'The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nanjing Sanhome Pharmaceutical, Co., Ltd.'}, 'officialTitle': 'A Single-center, Open-label, Single-dose Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'SHC013-I-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C] SH-1028', 'description': 'Volunteers will receive 200 mg \\[14C\\] SH-1028 containing a nominal 88 μCi activity, administered by mouth, as a solution.', 'interventionNames': ['Drug: [14C] SH-1028']}], 'interventions': [{'name': '[14C] SH-1028', 'type': 'DRUG', 'description': 'Volunteer will receive a single oral dose of 200 mg/88 uCi \\[14C\\]SH-1028 as a solution on Day 1', 'armGroupLabels': ['[14C] SH-1028']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Feng Shao, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine'}, {'name': 'Wei Liu, M.A', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Sanhome Pharmaceutical, Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}