Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT06098027
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2023-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of [14C]CS0159 in China Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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': '2023-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-09-21', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mass Balance', 'timeFrame': 'Screening period (-48 hours) to 240 hours', 'description': 'Mass balance recovery of total radioactivity in urine and fecal samples.'}, {'measure': '[14C] CS0159 metabolite', 'timeFrame': 'Screening period (-48 hours) to 240 hours', 'description': 'Identification of the major metabolites of CS0159 in human plasma, urine and faeces, determine the main Determine the main biotransformation pathways and calculate the percentage of the administered dose of the prodrug and each metabolite in urine and faeces, and plasma prodrugs and circulating metabolites as a percentage of total exposure AUC.'}, {'measure': 'Radioactivity of CS0159', 'timeFrame': 'Up to 90 hours post dose', 'description': 'Whole blood to plasma total radioactivity ratio'}, {'measure': 'Area under the curve', 'timeFrame': 'Up to 90 hours post dose', 'description': 'Total radioactivity in plasma PK: AUC'}, {'measure': 'Highest radioactivity observed plasma concentration', 'timeFrame': 'Up to 90 hours post dose', 'description': 'Total radioactivity in plasma PK: Cmax'}, {'measure': 'Time for Cmax', 'timeFrame': 'Up to 90 hours post dose', 'description': 'Total radioactivity in plasma PK: Tmax'}, {'measure': 'Elimination half-life', 'timeFrame': 'Up to 90 hours post dose', 'description': 'Total radioactivity in plasma PK: T1/2'}], 'secondaryOutcomes': [{'measure': 'Blood plasma PK', 'timeFrame': 'Up to 90 hours post dose', 'description': 'other major metabolites in plasma( if any).'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 240 hours post dose', 'description': 'All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs'}, {'measure': 'AUC of CS0159', 'timeFrame': 'Up to 90 hours post dose', 'description': 'Area under the plasma concentration time curve of CS0159'}, {'measure': 'Cmax of CS0159', 'timeFrame': 'Up to 90 hours post dose', 'description': 'Highest observed plasma concentration of CS0159'}, {'measure': 'T1/2 of CS0159', 'timeFrame': 'Up to 90 hours post dose', 'description': 'Elimination half-life of CS0159'}, {'measure': 'Tmax of CS0159', 'timeFrame': 'Up to 90 hours post dose', 'description': 'Time for Cmax of CS0159'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Biliary Cholangitis']}, 'descriptionModule': {'briefSummary': 'Study of \\[14C\\]CS0159 in China Healthy Subjects.', 'detailedDescription': 'A phase I study to quantify the total mass balance in healthy subjects after a single dose of \\[14C\\]CS0159.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male subjects between the ages of 18 and 45 years (inclusive).\n2. Subjects should not weigh less than 50 kg, BMI between 19\\~26 kg/㎡.\n3. No sperm donation or fertility plan during the study and within 12 months after the end of the study.\n4. Understand the purpose and requirements of trial, subjects who have voluntarily participated in the study and signed the ICF, completion of tests as required.\n\nExclusion Criteria:\n\n1. With abnormal and clinically significant comprehensive physical examinations, vital signs,laboratory examinations, 12-ECG, chest X-ray, and abdominal ultrasound.\n2. 12-ECG QT(QTcF)\\>450ms.\n3. The history of drug allergy.\n4. Patients with malabsorption and gastrointestinal disorders or history of Vomiting, diarrhoea in the week prior to the screening period.\n5. Patients with difficulty swallowing or interfere with drug absorption.\n6. HBs Ag or E antigen, TPAb, or HIV-Ag/Ab positive person.\n7. Have taken any clinical trial medication or participated in any other clinical trial within 3 months prior to the screening period.\n8. Habitual constipation or diarrhoea.\n9. Heavy smokers addicts\n10. Heavy drinker addicts.\n11. Has drug abuse history or positive drug abuse test results.\n12. Heavy caffeine addicts.\n13. Special dietary requirements.\n14. Poor adherence or any other conditions judged by the investigator as not suitable for the study.'}, 'identificationModule': {'nctId': 'NCT06098027', 'briefTitle': 'Study of [14C]CS0159 in China Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Cascade Pharmaceuticals, Inc'}, 'officialTitle': '[14C]CS0159 in Chinese Healthy Subjects for Mass Balance Phase I Study', 'orgStudyIdInfo': {'id': 'CS0159-001B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]CS0159', 'description': 'Single oral dose of 4mg \\[14C\\]CS0159', 'interventionNames': ['Drug: [14C]CS0159']}], 'interventions': [{'name': '[14C]CS0159', 'type': 'DRUG', 'description': 'Single oral administration of 4mg \\[14C\\]CS0159', 'armGroupLabels': ['[14C]CS0159']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'overallOfficials': [{'name': 'Deng Rong', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cascade Pharmaceuticals, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cascade Pharmaceuticals, Inc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}