Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-29 @ 7:29 PM
Study NCT ID:
NCT03530228
Status:
UNKNOWN
Last Update Posted:
2018-05-21
First Post:
2018-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of Tegoprazan on Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631239', 'term': 'tegoprazan'}, {'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Cohort 1: crossover Cohort 2: parallel Cohort 3: single group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-05-18', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(0-24h) of tegoprazan', 'timeFrame': 'up to 7 days', 'description': 'Area Under the Curve(0-24h) of tegoprazan'}, {'measure': 'Cmax of tegoprazan', 'timeFrame': 'up to 7 days', 'description': 'Maximum Plasma Concentration of tegoprazan'}, {'measure': 'Gastric pH', 'timeFrame': 'up to 7 days', 'description': 'Gastric pH'}, {'measure': 'Serum gastrin concentration', 'timeFrame': 'up to 7 days', 'description': 'Serum gastrin concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacodynamics', 'Pharmacokinetics', 'Healthy Male Volunteers']}, 'descriptionModule': {'briefSummary': 'A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral administration in healthy male subjects', 'detailedDescription': '* To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan between dose groups in healthy H. pylori negative males.\n* To evaluate the pharmacokinetics and pharmacodynamics of multiple oral dose of tegoprazan under the fed state in healthy H. pylori negative males.\n* To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan in healthy H. pylori positive males.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adult males aged ≥ 19 years and ≤ 50 years\n* Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening\n\nExclusion Criteria:\n\n* Presence or history of clinically significant diseases\n* Presence or history of gastrointestinal disorder (gastric ulcer, GERD, - Crohn's disease, etc.)\n* Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity\n* Serologic test positive\n* Abnormal obstacle to insertion and maintenance of pH meter catheter\n* History of drug abuse\n* Excessive caffeine intake or persistent alcohol intake\n* Not use of a medically acceptable method of contraception"}, 'identificationModule': {'nctId': 'NCT03530228', 'briefTitle': 'A Phase 1 Study of Tegoprazan on Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'HK inno.N Corporation'}, 'officialTitle': 'A Randomized, Open-label, Active-controlled, Single/Multiple-dose Phase 1 Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Tegoprazan After Oral Administration in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'CJ_APA_109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A: Tegoprazan (C1)', 'description': 'Tegoprazan QD, oral administration', 'interventionNames': ['Drug: Tegoprazan (C1)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: Tegoprazan (C1)', 'description': 'Tegoprazan QD, oral administration', 'interventionNames': ['Drug: Tegoprazan (C1)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C: Tegoprazan (C1)', 'description': 'Tegoprazan BID, oral administration', 'interventionNames': ['Drug: Treatment C: Tegoprazan (C1)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1: Tegoprazan (C2)', 'description': 'Tegoprazan QD, oral administration, for 7 days', 'interventionNames': ['Drug: Tegoprazan (C2)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Tegoprazan (C2)', 'description': 'Tegoprazan QD, oral administration, for 7 days', 'interventionNames': ['Drug: Tegoprazan (C2)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3: Esomeprazole (C2)', 'description': 'Esomeprazole QD, oral administration, for 7 days', 'interventionNames': ['Drug: Esomeprazole (C2)']}, {'type': 'EXPERIMENTAL', 'label': 'Tegoprazan (C3)', 'description': 'Tegoprazan QD, oral administration', 'interventionNames': ['Drug: Tegoprazan (C3)']}], 'interventions': [{'name': 'Tegoprazan (C1)', 'type': 'DRUG', 'description': 'Tegoprazan QD, oral administration. Treatment A', 'armGroupLabels': ['Treatment A: Tegoprazan (C1)']}, {'name': 'Tegoprazan (C1)', 'type': 'DRUG', 'description': 'Tegoprazan QD, oral administration. Treatment B', 'armGroupLabels': ['Treatment B: Tegoprazan (C1)']}, {'name': 'Treatment C: Tegoprazan (C1)', 'type': 'DRUG', 'description': 'Tegoprazan BID, oral administration', 'armGroupLabels': ['Treatment C: Tegoprazan (C1)']}, {'name': 'Tegoprazan (C2)', 'type': 'DRUG', 'description': 'Tegoprazan QD, oral administration, for 7 days. Group 1', 'armGroupLabels': ['Group 1: Tegoprazan (C2)']}, {'name': 'Tegoprazan (C2)', 'type': 'DRUG', 'description': 'Tegoprazan QD, oral administration, for 7 days. Group 2', 'armGroupLabels': ['Group 2: Tegoprazan (C2)']}, {'name': 'Esomeprazole (C2)', 'type': 'DRUG', 'description': 'Esomeprazole QD, oral administration, for 7 days. Group 3', 'armGroupLabels': ['Group 3: Esomeprazole (C2)']}, {'name': 'Tegoprazan (C3)', 'type': 'DRUG', 'description': 'Tegoprazan QD, oral administration', 'armGroupLabels': ['Tegoprazan (C3)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'In Jin Jang, MD, PhD', 'role': 'CONTACT', 'email': 'ijjang@snu.ac.kr', 'phone': '82-2-2072-1666'}, {'name': 'Mu Seong Ban, MD', 'role': 'CONTACT', 'email': 'ban2699@snu.ac.kr', 'phone': '82-2-2072-1666'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'In Jin Jang, MD, PhD', 'role': 'CONTACT', 'email': 'ijjang@snu.ac.kr', 'phone': '82-2-2072-1666'}, {'name': 'Mu Seong Ban, MD', 'role': 'CONTACT', 'email': 'ban2699@snu.ac.kr', 'phone': '82-2-2072-1666'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HK inno.N Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}