Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT04476394
Status:
UNKNOWN
Last Update Posted:
2020-07-20
First Post:
2020-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-20 mg/100 μCi Anaprazole Sodium Enteric-coated Capsule in Healthy Adult Male Subjects
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2020-07-15', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma', 'timeFrame': 'Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)', 'description': 'Cmax is the peak plasma concentration'}, {'measure': 'Tmax of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma', 'timeFrame': 'Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)', 'description': 'Tmax is the time to maximum plasma concentration'}, {'measure': 'AUC of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma', 'timeFrame': 'Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)', 'description': 'AUC is area under the plasma concentration-time curve'}, {'measure': 'Cumulative excretion and cumulative excretion rate in urine', 'timeFrame': 'Hour 24 pre-dose and 0-4，4-8，8-12，12-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)', 'description': 'Sum of the percent of the total radioactivity recovered in urine relative to the administered radioactivity dose'}, {'measure': 'Cumulative excretion and cumulative excretion rate in feces', 'timeFrame': 'Hour 24 pre-dose and 0-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)', 'description': 'Sum of the percent of the total radioactivity recovered in feces relative to the administered radioactivity dose'}, {'measure': 'Radioactivity spectrum indentification of metabolites in plasma', 'timeFrame': 'Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)', 'description': 'plasma concentration of metabolites'}, {'measure': 'Radioactivity spectrum indentification of metabolites in urine', 'timeFrame': 'Hour 24 pre-dose and 0-4，4-8，8-12，12-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)', 'description': 'Concentration of metabolites in urine'}, {'measure': 'Concentration of metabolites in feces', 'timeFrame': 'Hour 24 pre-dose and 0-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)', 'description': 'Sum of the percent of the total radioactivity recovered in feces relative to the administered radioactivity dose'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Male Volunteers']}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single oral dose of \\[14C\\]-20 mg/100 μCi Anaprazole Sodium enteric-coated capsule in healthy adult male subjects. Whole blood, plasma samples will be collected at hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration); urine samples will be collected at hour 24 pre-dose and 0-4，4-8，8-12，12-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate) ; fecal samples will be collected at hour 24 pre-dose and 0-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate) following the start of administration to measure total radioactivity and plasma drug concentrations.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1.The subject is a Chinese adult male, aged 18 to 45 years, inclusive.\n* 2.The subject weighed at least 50.0 kg and had a body mass index (BMI) between 19.0 kg/m\\^2 and 26.0 kg/m\\^2, inclusive.\n* 3\\. Participants with evaluations of vital signs, physicial examination results,clinical laboratory and ECG testing outside the reference range that are deemed not clinically significant at investigator discretion at screening.\n* 4.The subject with childbearing potential agrees that the subject and his sexual partner use adequate contraception from signing of informed consent throughout the duration of the study and for 6 months after study completion.\n* 5.The subject is capable of understanding and complying with protocol requirements, and signed and dated a written informed consent form voluntarily\n\nExclusion Criteria:\n\n* 1.Has clinical significant drug allergy or allergic disease history(Such as asthma, urticaria, eczema dermatitis, etc), or has hypersensitivity or allergy to investigatory drugs or related supplements；\n* 2.Has clinical significant ECG abnormal history or family history of long QT syndrome(Grandparents, parents and siblings)\n* 3.Any disease or medical history that may significantly affect the absorption, distribution, metabolism, and excretion of drugs, or any condition that may pose a hazard to the subject. Such as:\n\n * Inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal / rectal bleeding, persistent nausea, or other clinically significant gastrointestinal abnormalities;\n * Has suffered from gastrointestinal diseases or complications that may affect the absorption of drugs (ie: malabsorption, gastroesophageal reflux, peptic ulcer, erosive esophagitis, frequent heartburn) within 6 months before screening or had history of gastrointestinal surgery (for example: gastrectomy, gastrointestinal anastomosis, intestinal resection, gastric bypass, gastric segmentation or gastric banding, cholecystectomy, except for appendicitis surgery and proctectomy);\n * Evidence of liver disease or clinically impaired liver function at the time of screening (eg AST, ALT or total bilirubin\\> 1.5 times ULN);\n * A history or evidence of nephropathy or renal insufficiency at the time of screening, showing clinically significant abnormality of creatinine or abnormal urine composition (such as proteinuria, creatinine\\> 176.8 umol / L, etc.)\n * Has difficulty swallowing oral preparations.\n* 4.Thyroid stimulating hormone (TSH)\\> ULN; or serum free triiodothyronine (FT3)\\> ULN; or serum free thyroxine (FT4)\\> ULN at the time of screening;\n* 5\\. Frequent smokers and alcoholics within 3 months before screening (smoke more than 5 cigarettes / day, drink more than 21 units of alcohol per week, 1 unit = 360 mL beer or 45 mL liquor or 150 mL wine), or can't stop using any tobacco products, and alcohol intake during the study period ; or those who have a positive alcohol breath test before enrollment;\n* 6\\. Has received any investigational compound (including post-marketing investigational drugs) or participated in clinical trials of any drugs /devices within 3 months before screening;\n* 7\\. A history of drug abuse within 12 months before screening or a positive urine test result at screening;\n* 8\\. Has used any prescription drugs, non-prescription drugs (including chemical drugs, vitamin drugs, Chinese herbal medicines, etc.) within 4 weeks before administration of investigational drugs;\n* 9\\. Has taken foods that affect CYP3A4 (such as grapefruit or beverages containing grapefruit) within 2 weeks before administration of investigational drugs;\n* 10\\. Human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C antibody, and Treponema pallidum specific antibody test results were positive at screening;\n* 11\\. Has difficulty in venous blood collection or halo acupuncture;\n* 12.Blood donation / blood loss ≥200 mL within 1 month, or ≥400 mL within 3 months before screening; or has blood donation plan during the period of medication of investigational drugs and within 3 months after drug withdrawal;\n* 13\\. Has special dietary requirements and cannot follow the unified dietary arrangements;\n* 14\\. Has particpated in another clinical study with radioactive labeling within 1 year before administration.\n* 15\\. Has significant radiation exposure (Radiation exposure from chest X-ray, CT scan or barium meal examination more than once, or be engaged in radiation related occupations) within 1 year before administration.\n* 16\\. Any conditions in which considered by investigator not be appropriate to participate in this trial."}, 'identificationModule': {'nctId': 'NCT04476394', 'briefTitle': 'Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-20 mg/100 μCi Anaprazole Sodium Enteric-coated Capsule in Healthy Adult Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sihuan Pharmaceutical Holdings Group Ltd.'}, 'officialTitle': 'A Single-center, Open, Single Dose Mass Balance Study to Assess the Absorption, Metabolism, Excretion of [14C]-20 mg/100 μCi Anaprazole Sodium Enteric-coated Capsule in Chinese Health Adult Male Subjects', 'orgStudyIdInfo': {'id': '3571-MB-1005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Administered orally once', 'interventionNames': ['Drug: [14C]-Anaprazole Sodium enteric-coated capsule']}], 'interventions': [{'name': '[14C]-Anaprazole Sodium enteric-coated capsule', 'type': 'DRUG', 'description': '\\[14C\\]-Anaprazole Sodium enteric-coated capsule', 'armGroupLabels': ['1']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sihuan Pharmaceutical Holdings Group Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}