Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-02 @ 1:20 AM
Study NCT ID:
NCT06437951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634065', 'term': 'fexuprazan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK of Fexuprazan', 'timeFrame': '0 and 72hour', 'description': '1\\. Blood and urinary concentrations of Fexuprazan by part'}, {'measure': 'PK of metabolite', 'timeFrame': '0 and 72hour', 'description': '1\\. Blood and urinary concentrations of metabolite by part'}, {'measure': 'PD of Fexuprazan', 'timeFrame': 'up to 15days', 'description': 'pH monitoring'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erosive Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy adult volunteers aged 19 to 50 at the time of screening tests\n2. Those who weigh more than 50.0 kg, 90.0 kg or less, and have a BMI of 18.5 or more and 29.9 or less at the time of screening inspection BMI (kg/m2) = Weight (kg) / {Height (m)}2\n3. In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in surgical infertility (bilateral ovarian obstruction, hysterectomy, bilateral ovarian resection, etc.)\n4. A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and agrees in writing before a screening procedure\n5. A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc\n\nExclusion Criteria:\n\n1. Clinically significant hepatomegaly (severe liver disorder, viral hepatitis, etc.), kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood and tumor, cardiovascular system (heart failure, Torsades de points, etc.), urinary system, mental system (fever disorder, obsessive compulsive disorder, etc.), sexual dysfunction, etc\n2. A person who has a history of gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastritis, gastroesophageal reflux disease, etc.) or surgery (except simple appendectomy or hernia) that may affect the safety, pharmacokinetics and pharmacodynamic evaluation of clinical medicines\n3. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n4. A person who has been tested positive for Helicobacter pylori\n5. Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc"}, 'identificationModule': {'nctId': 'NCT06437951', 'briefTitle': 'to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Single/Multiple-dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics After Intravenous DWP14012 Injection in Healthy Participants', 'orgStudyIdInfo': {'id': 'DW_DWJ1521104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part1_test group', 'description': 'IV injection of test drugs by dose group', 'interventionNames': ['Drug: Fexuprazan Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part1_placebo group', 'description': 'IV injection of test drugs by dose group', 'interventionNames': ['Drug: Fexuprazan Injection placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part2', 'description': 'All Participants take IV injection of test drugs', 'interventionNames': ['Drug: Fexuprazan Injection_part 2']}, {'type': 'EXPERIMENTAL', 'label': 'Part3_test group', 'description': 'In the case of test group, take IV injection in the period 1 and take a tablet in the period 2', 'interventionNames': ['Drug: Fexuprazan Injection_part 3', 'Drug: Fexuprazan tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part3_reference group', 'description': 'In the case of reference group, take a tablet in the period 1 and take IV injection in the period 2', 'interventionNames': ['Drug: Fexuprazan Injection_part 3', 'Drug: Fexuprazan tablet']}], 'interventions': [{'name': 'Fexuprazan Injection', 'type': 'DRUG', 'description': '20/40/80 mg', 'armGroupLabels': ['Part1_test group']}, {'name': 'Fexuprazan Injection placebo', 'type': 'DRUG', 'description': '20/40/80 mg', 'armGroupLabels': ['Part1_placebo group']}, {'name': 'Fexuprazan Injection_part 2', 'type': 'DRUG', 'description': '20mg', 'armGroupLabels': ['Part2']}, {'name': 'Fexuprazan Injection_part 3', 'type': 'DRUG', 'description': '40mg', 'armGroupLabels': ['Part3_reference group', 'Part3_test group']}, {'name': 'Fexuprazan tablet', 'type': 'DRUG', 'description': '40mg', 'armGroupLabels': ['Part3_reference group', 'Part3_test group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sujong Lee, Ph.D', 'role': 'CONTACT', 'email': 'leesj0323@snu.ac.kr', 'phone': '027408910'}], 'overallOfficials': [{'name': 'Injin zhang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University College of Medicine and Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}