Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
Study NCT ID:
NCT06362460
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Balance Study of [14C]RAY1216 in Healthy Adult Male Subjects in China
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': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-14', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total radioactivity in plasma PK', 'timeFrame': 'Up to 7 days from the start of administration.', 'description': 'Cmax'}, {'measure': 'Total radioactivity in plasma PK', 'timeFrame': 'Up to 7 days from the start of administration.', 'description': 'AUC0-t'}, {'measure': 'Total radioactivity in plasma PK', 'timeFrame': 'Up to 7 days from the start of administration.', 'description': 'CL/F'}, {'measure': 'Total radioactivity in plasma PK', 'timeFrame': 'Up to 7 days from the start of administration.', 'description': 'Vz/F'}, {'measure': 'Mass balance recovery of total radioactivity in all (urine, faeces) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae)', 'timeFrame': 'Up to 14 days from the start of administration.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0', 'timeFrame': 'Up to 14 days (approx) from the start of administration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of \\[14C\\]RAY1216 in healthy Chinese male participants, revealing the overall pharmacokinetic characteristics of RAY1216.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and female participants between 18-45 years (Both inclusive);\n2. Body weight≥50kg.Body mass index (BMI) 18\\~28 kg/m2 (Both inclusive); BMI is determined by the following equation: BMI = weight/height2 (kg/m2);\n3. Participants who voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.\n\nExclusion Criteria:\n\n1. Any clinically significant abnormality upon physical examination or in the clinical laboratory tests. History or presence of a clinically significant gastrointestinal, renal, hepatic, neurologic, hematic, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular disorder(s) (but not limited to above disorders).\n2. Presence of human immunodeficiency virus (HIV), viral hepatitis(including hepatitis C virus (HCV) or hepatitis B virus (HBV) ,treponema pallidum antibodies at screening.\n3. Participants who donated blood or bleeding profusely(\\> 400 mL)in the 3 months preceding study screening.\n4. Participants who have undergone surgery within 6 months before the screening period or whose surgical incision is not completely healed; Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, or an open biopsy or significant traumatic injury;\n5. Workers engaged in conditions requiring long-term exposure to radioactivity; Or have significant radiation exposure (≥2 chest/abdomen CT, or ≥3 other types of X-ray examinations) within 1 year before this study or have participated in the radiopharmaceutical labeling test;\n6. Participants who smoked an average of \\>5 cigarettes per day in the previous 3 months or habitually used nicotine-containing products and were unable to quit during the trial period;\n7. Substance abuse or use of soft drugs (e.g., marijuana) in the 3 months prior to the screening period or use of hard drugs (e.g., cocaine, amphetamines, etc.) in the 1 year prior to the screening period; Or screening for positive urine drug abuse (drug) tests;\n8. Participants who have special dietary requirements and cannot comply with a uniform diet;\n9. History of allergic conditions or allergic diseases, or a history of allergic reactions attributed to RAY1216 or any of the ingredients of its formulation or similar drugs.'}, 'identificationModule': {'nctId': 'NCT06362460', 'briefTitle': 'Mass Balance Study of [14C]RAY1216 in Healthy Adult Male Subjects in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Raynovent Biotech Co., Ltd'}, 'officialTitle': 'Single-center, Open-label, Non-randomized and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 400mg [14C]RAY1216', 'orgStudyIdInfo': {'id': 'RAY1216-23-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]RAY1216', 'interventionNames': ['Drug: [14C] RAY1216']}], 'interventions': [{'name': '[14C] RAY1216', 'type': 'DRUG', 'description': '400 mg suspension containing 100μCi of \\[14C\\]RAY1216', 'armGroupLabels': ['[14C]RAY1216']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bengbu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Bengbu Medical College', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Raynovent Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}