Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT06438367
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2024-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TGRX-326 Pharmacokinetic Mass Balance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2024-05-27', 'studyFirstSubmitQcDate': '2024-05-27', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine radioactivity', 'timeFrame': 'Day-1 (day before dosing), Day 1 to Day 18 after dosing', 'description': '\\[C14\\]TGRX-326 radioactivity detected in urine'}, {'measure': 'Fecal radioactivity', 'timeFrame': 'Day-1 (day before dosing), Day 1 to Day 18 after dosing', 'description': '\\[C14\\]TGRX-326 radioactivity detected in feces'}, {'measure': 'Plasma AUC (Area under curve) percentage', 'timeFrame': 'Day-1 (day before dosing), Day 1 to Day 18 after dosing', 'description': 'percentage of \\[C14\\]TGRX-326 radioactivity in plasma'}, {'measure': 'Urine %Dose', 'timeFrame': 'Day-1 (day before dosing), Day 1 to Day 18 after dosing', 'description': 'percentage of \\[C14\\]TGRX-326 radioactivity in urine'}, {'measure': 'Fecal %Dose', 'timeFrame': 'Day-1 (day before dosing), Day 1 to Day 18 after dosing', 'description': 'percentage of \\[C14\\]TGRX-326 radioactivity in feces'}, {'measure': 'Plasma Cmax', 'timeFrame': 'Day-1 (day before dosing), Day 1 to Day 18 after dosing', 'description': 'Maximum concentration of \\[C14\\]TGRX-326 measured in plasma'}, {'measure': 'Plasma Tmax', 'timeFrame': 'Day-1 (day before dosing), Day 1 to Day 18 after dosing', 'description': 'Time to maximum concentration of \\[C14\\]TGRX-326 measured in plasma'}], 'secondaryOutcomes': [{'measure': 'Adverse events/serious adverse events', 'timeFrame': 'From screening through completion of study, an average of 1 to 1.5 months.', 'description': 'to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a pharmacokinetic study for TGRX-326 on mass balance to evaluate distribution, metabolism and excretion of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.', 'detailedDescription': 'This study is designed as a single-center, single-dose, non-randomized and open-label study. The study will be conducted in healthy male participants to evaluate distribution, metabolic pathways and route of excretion of TGRX-326 using the Carbon-14 labelled isotope of TGRX-326 compound. Safety evaluation will also be conducted.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adult males\n* Age between 18 and 45 years old (both limits included)\n* Body weight index between 19.0 and 26.0 kg/m2 (both limits included), and body weight not less than 50.0kg\n* Willing to consent\n* Able to communicate with investigator and complete study according to study protocol\n\nExclusion Criteria:\n\n* Clinically significant results from comprehensive physical and clinical examinations\n* Positive results on hepatitis, HIV or syphilis\n* Clinically significant results from eye examination\n* Usage of inducer or inhibitor drugs to drug metabolism with 30 days prior to screening\n* Usage of any prescription or non-prescription drug, Chinese herbal medicine or dietary supplements\n* Presence of any significant medical history or clinical conditions that could affect study results per investigators' judgement\n* Presence of any condition that could affect drug absorption\n* Reception of major surgery within 6 months before screening, or surgical wounds not completely healed\n* Presence of allergic reactions or may be allergic to ingredients in the investigational drug\n* Presence of hemorrhoids, or having history of or is having conditions that cause bloody feces\n* Habitual congestion or diarrhea\n* Alcohol abuse or excessive alcohol consumption within 6 months before screening\n* Excessive smoking within 3 months before screening\n* Substance abuse or positive results on urine substance test\n* Habits of grapefruit juice consumption or excessive caffeinated drinks consumption\n* History of long-term exposure under radiation; or significant radiation exposure 1 year before this study; or participation in other radioactive drug studies\n* Having difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness\n* Participation in any other clinical studies within 3 months before screening\n* Reception of vaccine within 1 months before screening, or planning to be vaccinated during the study\n* Planning to have children or donate sperms during the study and within 1 year after the study, or Not agreeing to take contraceptive measures during and within 1 year after study completion\n* Blood donation or blood loss of \\> 400 ml within 3 months before screening; blood donation or blood loss of \\> 200 ml within 1 month before screening; reception of blood transfusion within 1 months before screening, or planning to donate blood within 3 months after study completion\n* Having special dietary requirements and unable to follow the uniform dietary plan in the study\n* Any conditions that the investigator deemed unfit for the study"}, 'identificationModule': {'nctId': 'NCT06438367', 'briefTitle': 'TGRX-326 Pharmacokinetic Mass Balance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen TargetRx, Inc.'}, 'officialTitle': 'Mass Balance Study of [14C]TGRX-326 in Healthy Adult Chinese Male Participants', 'orgStudyIdInfo': {'id': 'TGRX-326-1004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: TGRX-326', 'description': 'healthy subjects will be given 60mg/100uCi\\[14C\\]TGRX-326 in suspension', 'interventionNames': ['Drug: [14C]TGRX-326']}], 'interventions': [{'name': '[14C]TGRX-326', 'type': 'DRUG', 'otherNames': ['TGRX-326'], 'description': 'Healthy subjects will be given TGRX-326 60 mg orally on day 1.', 'armGroupLabels': ['Experimental: TGRX-326']}]}, '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': 'Liyan Miao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen TargetRx, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}