Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
Study NCT ID:
NCT06823232
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2025-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on the Substance Balance of [14C]XY0206 in Healthy Adult Chinese Men
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': '2024-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'excrement', 'timeFrame': '22 days', 'description': 'The total radioactivity of the collected biological samples (urine+feces) from each subject exceeds 90% of the administered dose, and the radioactivity collected for two consecutive days is less than 1% of the administered dose.'}, {'measure': 'Radioactive blood sample', 'timeFrame': '22 days', 'description': 'The total radioactive concentration of plasma samples is less than 3 times the background value'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolism of Radioactive Substances']}, 'descriptionModule': {'briefSummary': 'The main purpose of this clinical trial is to quantitatively analyse the total radioactivity in the excreta of subjects after oral administration of \\[14C\\]XY0206, and to obtain data on human radioactive excretion rate and main excretion routes and the radioactivity of human plasma, urine, and faeces after oral administration of \\[14C\\]XY0206 by subjects Metabolite profiling, identification of major metabolites, determination of metabolic pathways and elimination pathways; Subjects who met the criteria fasted for at least 10h before administration and took \\[14C\\]XY0206 suspension (containing about 37.5mg/100µCi\\[14C\\]XY0206) orally on an empty stomach in the morning of the first day of administration (DI).Subjects will also complete urine, stool and blood collection within a specified period of time。'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy adult males;\n2. Age: 18-45 years old (including boundary values);\n3. Weight: The subject's weight is not less than 50 kg, and their body mass index (BMI) is between 19-26 kg/m2 (including boundary values);\n4. Voluntary signing of informed consent form; The subjects are able to communicate well with the researchers and complete the experiment according to the protocol.\n\nExclusion Criteria:\n\n* Supplementary Examination:\n\n 1. Individuals who have undergone comprehensive physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine+occult blood), thyroid function, chest X-ray, abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidney), and other examinations that are abnormal and clinically significant;\n 2. Patients with clinically significant abnormal 12 lead electrocardiogram during the screening/baseline period, or those with QTc interval (QTcF) ≥ 450 ms corrected according to Fridericia's criteria;\n 3. Individuals who are positive for any one of hepatitis B virus surface antigen, hepatitis B virus e antigen, hepatitis B virus core antibody, hepatitis C virus antibody, HIV antibody, and Treponema pallidum antibody.\n\n Medication history:\n 4. Have used any drugs that inhibit or induce liver drug metabolizing enzymes within 28 days prior to administration (see Appendix 1 for details);\n 5. Any medication that may cause QTc interval prolongation has been used within 28 days prior to administration (see Appendix 2 for details);\n 6. Have used any prescription, over-the-counter, herbal or health supplements within 14 days prior to administration;\n 7. Individuals who have participated in any clinical trials and received intervention with investigational drugs or medical devices within the last 3 months prior to the screening period;\n 8. Screening individuals who have received the vaccine within the previous month or have a vaccination plan during the trial period;\n\nHistory of illness and surgery:\n\n9\\) Any clinical history of serious diseases or conditions that researchers believe may affect the test results, including but not limited to a history of motor system, nervous system, endocrine system, circulatory system, respiratory system, digestive system, urinary system, reproductive system diseases; 10) History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, twisted ventricular tachycardia, ventricular tachycardia, atrioventricular block, and any type of cardiovascular disease/disease/surgery that may increase QT interval prolongation, or a history of other risk factors leading to TdP (such as hypokalemia, hypomagnesemia, congenital long QT syndrome or family history of long QT syndrome or Brugada syndrome); 11) Having undergone major surgery or incomplete healing of surgical incision within the 6 months prior to the screening period; Major surgeries include but are not limited to any surgery involving significant bleeding risks, prolonged general anesthesia, or open biopsy or significant traumatic injuries; 12) Allergic constitution, such as those with a known history of allergies to two or more substances; Or those who may be allergic to the investigational drug or its excipients, as determined by researchers; 13) Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as inability to swallow, intestinal obstruction, digestive ulcers, etc.); Hemorrhoids or perianal diseases with regular/ongoing rectal bleeding, irritable bowel syndrome, inflammatory bowel disease; habits and customs: 15) Habitual constipation or diarrhea; 16) Excessive drinking or frequent alcohol consumption within the first 6 months of the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); 17) Individuals who smoke more than 5 cigarettes per day or habitually use nicotine containing products during the first 3 months of the screening period and are unable to quit during the trial period; 18) Individuals with a history of drug abuse or addiction in the past 5 years; 19) Habitual consumption of grapefruit juice or excessive amounts of tea, coffee, and/or caffeinated beverages, and inability to quit during the trial period; other: 20) Individuals with positive results in urine drug abuse screening and alcohol breath test during the baseline period; 21) Engage in work that requires long-term exposure to radioactive conditions; Or those who have had significant radiation exposure (≥ 2 chest/abdominal CT scans, or ≥ 3 other types of X-ray examinations) or have participated in radiopharmaceutical labeling trials within 1 year prior to the experiment; 22) Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection; 23) Those who have planned to give birth or donate sperm during the trial period and within 6 months after completion of the trial, or those who do not agree that the subjects and their spouses should take strict contraceptive measures during the trial period and within 6 months after completion of the trial; 24)Individuals who have experienced blood loss or donated up to 400 mL of blood within the past 3 months prior to the screening period, or who have received blood transfusions within the past 1 month; 25)Researchers believe that subjects with any factors that are not suitable for participation in this experiment"}, 'identificationModule': {'nctId': 'NCT06823232', 'briefTitle': 'A Study on the Substance Balance of [14C]XY0206 in Healthy Adult Chinese Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shijiazhuang Yiling Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Study on the Substance Balance of [14C]XY0206 in Healthy Adult Chinese Men', 'orgStudyIdInfo': {'id': 'XY0206AML1006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]XY0206', 'description': '37.5 mg/100 µCi \\[14C\\]XY0206', 'interventionNames': ['Drug: [14C]XY0206']}], 'interventions': [{'name': '[14C]XY0206', 'type': 'DRUG', 'description': 'On the morning of the day of medication (D1), the subject took \\[14C\\] XY0206 suspension orally on an empty stomach (containing approximately 37.5 mg/100 µ Ci \\[14C\\] XY0206).', 'armGroupLabels': ['[14C]XY0206']}]}, 'contactsLocationsModule': {'locations': [{'zip': '102200', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Gaobo Hospital, Life Science Park Road, Changping District, Beijing', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shijiazhuang Yiling Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}