Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT05868967
Status:
UNKNOWN
Last Update Posted:
2023-05-22
First Post:
2023-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese 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': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single-center, single-dose, open-label design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2023-04-07', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tmax', 'timeFrame': 'Up to 168hours(approx) from administration', 'description': 'Time to peak Concentration'}, {'measure': 'Cmax', 'timeFrame': 'Up to 168hours(approx) from administration', 'description': 'Maximum Concentration'}, {'measure': 'AUC0-t', 'timeFrame': 'Up to 168hours(approx) from administration', 'description': 'Area under the plasma concentraion-time curve'}, {'measure': 'AUC0-∞', 'timeFrame': 'Up to 168hours(approx) from administration', 'description': 'Area under the curve from time 0 extrapolated to infinite time'}, {'measure': 't1/2', 'timeFrame': 'Up to 168hours(approx) from administration', 'description': 'Elimination Phase Half-life'}, {'measure': 'MRT', 'timeFrame': 'Up to 168hours(approx) from administration', 'description': 'Mean Residence Time'}, {'measure': 'CL/F', 'timeFrame': 'Up to 168hours(approx) from administration', 'description': 'apparent oral clearnace'}, {'measure': 'Vd/F', 'timeFrame': 'Up to 168hours(approx) from administration', 'description': 'apparent oral volume of distribution'}, {'measure': 'Ratio of total radioactivity in whole blood/plasma', 'timeFrame': 'Up to 168hours(approx) from administration', 'description': 'Total measured radioactivity content of urine and fecal samples collected at each sampling interval'}, {'measure': 'Cumulative recovery of total radioactive substances', 'timeFrame': 'Up to 168hours(approx) from administration', 'description': 'Measurement of cumulative recovery ratio in urine or/and feces to meet the criteria for termination'}], 'secondaryOutcomes': [{'measure': 'To observe the safety of [14C]DWP14012', 'timeFrame': 'Up to study completion, approximately up to 2000 hours', 'description': 'Adverse events, serious adverse events etc.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Phase 1 Study, Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the Mass Balance and Biotransformation of \\[14C\\]DWP14012 in Healthy Chinese Male Subjects', 'detailedDescription': 'This study is a single-center, single-dose, non-randomized, open-label design with two parts. Each subject will receive a single oral dose of \\[14C\\]DWP14012 suspension (containing approximately 40 mg/80 μCi \\[14C\\]DWP14012) under the fasting conditions'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy male subjects aged 18 to 45 years (including boundary values);\n2. Body weight ≥ 50.0 kg and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including boundary values);\n3. Subjects must give informed consent to this study before the study and voluntarily sign a written informed consent form;\n4. Have no plan for fertility/sperm donation during the study and within 1 year after completion of the study, and take strict contraceptive measures with their spouses (see Appendix 3 for details);\n5. Have good hygiene habits, and are able to communicate well with the investigator and complete the study in accordance with the study regulations.\n\nExclusion Criteria:\n\n1. Subjects with an allergic constitution, including those with a history of drug allergy or allergic reactions and are known to be allergic to this product or other P-CABs, PPIs or other drugs (e.g., aspirin and antibiotics); and those who are allergic to any food ingredients or have special requirements for diet and unable to take the unified diet;\n2. Subjects with clinically significant abnormalities or medical history of hepatic, renal, gastrointestinal, neurological, respiratory, endocrine, hematological, oncological, cardiovascular, urological, or psychiatric disorders;\n3. Subjects with abnormal and clinically significant results of vital signs, physical examination, laboratory tests (hematology, blood chemistry, urinalysis, coagulation function, thyroid functions (FT3, FT4, TSH), stool routine + occult blood), 12-lead electrocardiogram, abdominal B-ultrasound (hepatobiliary, pancreas, spleen and kidney) as judged by the investigator;\n4. Subjects who are positive for any one of the hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, and HIV antigen/antibody combination test (primary screening);\n5. Subjects with any medical condition that, in the opinion of the investigator, may increase the risk during the subject's participation in this study (especially a history of esophageal or gastrointestinal ulcers), may interfere with drug absorption, distribution, metabolism or excretion, or may impair protocol compliance;\n6. Subjects with frequent alcohol consumption within 6 months prior to screening, i.e., more than 14 units of alcohol per week (1 unit = 285 mL of beer or 25 mL of spirits containing 40% alcohol or 100 mL of wine); or alcoholics; or those with a positive alcohol breath test at screening and baseline admission;\n7. Subjects who have smoked more than 5 cigarettes per day or habitually used nicotine-containing products within 3 months before screening and are unable to withdraw during the study;\n8. Subjects who have used soft drugs (e.g., cannabis) within 3 months before screening or hard drugs (e.g., cocaine, amphetamines, phencyclidine, etc.) within 1 year before screening; or have a history of drug abuse; or have a positive urine drug test at screening and baseline admission;\n9. Subjects who have taken any investigational product or participated in any clinical trial of drugs within 3 months prior to screening;\n10. Subjects who have participated in blood donation within 3 months prior to screening with a total blood donation of ≥ 400 mL or total blood loss of ≥ 400 mL, or who have participated in blood donation within one month prior to screening with a total blood donation of ≥ 200 mL or total blood loss of ≥ 200 mL; or who have received blood transfusion; or who plan to donate blood within 1 month after the end of this study;\n11. Subjects who have used any medication that alters liver enzyme activity within 4 weeks prior to dosing (see Appendix 1 for details);\n12. Subjects who have used any prescription or over-the-counter drugs, any vitamin products, health care drugs or Chinese herbal medicines within 14 days prior to dosing;\n13. Subjects who have habitual consumption of grapefruit juice or excessive amounts of tea, coffee and/or caffeine-containing beverages, and are unable to withdraw during the study;\n14. Subjects with a history of fear of needles and hemophobia, difficulty in blood collection or intolerance to venipuncture blood collection; radiopharmaceutical labeling studies;\n15. Subjects whose work requires long-term exposure to radioactive conditions; or who have significant radioactive exposure (≥ 2 chest/ abdominal CTs, or ≥ 3 other types of X-rays) within 1 year prior to screening; or who have participated in radiopharmaceutical labeling studies;\n16. Subjects with other factors that are not suitable for participation in this study as judged by the investigator."}, 'identificationModule': {'nctId': 'NCT05868967', 'briefTitle': 'A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects', 'orgStudyIdInfo': {'id': 'DW_DWP14012112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]DWP14012', 'description': 'Type: \\[14C\\]DWP14012 suspension containing 40 mg/80 μCi Dosage: orally take the suspension', 'interventionNames': ['Drug: [14C]DWP14012']}], 'interventions': [{'name': '[14C]DWP14012', 'type': 'DRUG', 'description': 'Each subject will receive a single oral dose of \\[14C\\]DWP14012 suspension (containing approximately 40 mg/80 μCi \\[14C\\]DWP14012) under fasting conditions.', 'armGroupLabels': ['[14C]DWP14012']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing GoBroad Boren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Fang Hou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing GoBroad Boren Hospital'}, {'name': 'Wel Tan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing GoBroad Boren Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shanghai Haini Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}