Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-27 @ 5:17 PM
Study NCT ID:
NCT03009760
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2016-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Investigate Pharmacokinetics and Pharmacodynamics of CJ-12420 After Single and Multiple Dose Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2016-12-28', 'studyFirstSubmitQcDate': '2017-01-01', 'lastUpdatePostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of CJ-12420', 'timeFrame': 'up to 12 hours'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC) of CJ-12420', 'timeFrame': 'up to 12 hours'}, {'measure': 'Time of maximum observed concentration(tmax) of CJ-12420', 'timeFrame': 'up to 12 hours'}, {'measure': 'Half life(t1/2β) of CJ-12420', 'timeFrame': 'up to 12 hours'}, {'measure': 'Mean pH', 'timeFrame': 'Day -1, Day 1, Day 7 up to 24 hours', 'description': 'Data from the pH probe monitoring'}, {'measure': 'Time at pH > 4(%)', 'timeFrame': 'Day -1, Day 1, Day 7 up to 24 hours', 'description': 'the percent of time the pH as data from the pH probe monitoring'}, {'measure': 'Time at pH > 6(%)', 'timeFrame': 'Day -1, Day 1, Day 7 up to 24 hours', 'description': 'the percent of time the pH as data from the pH probe monitoring'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420 after single and multiple dose administration according to H. pylori infection.', 'detailedDescription': '1. Cohort 1: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the multiple dose administration in H. pylori negative volunteers.\n2. Cohort 2: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the single dose administration in H. pylori positive volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male volunteers between 20 to 45 years of age (inclusive)\n* Body mass index (BMI) in the range of 19\\~28 kg/㎡ and weighted at least 50kg\n* Medically healthy with no clinically significant vital signs (blood pressure in the sitting position, pulse rate)\n\n * 90 mmHg ≤ systolic blood pressure ≤ 140 mmHg\n * 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg\n * 45 beats per minute ≤ pulse rate ≤ 95 beats per minute\n* Understood the requirements of the study and voluntarily consented to participate in the study\n* Agreed to be sexually abstinent or to use a condom or spermicide when engaging in sexual activity and not to donate sperm during the course of the study for 30 days following completion of the study\n* Non-smokers or non-users of nicotine-containing products for at least 1 year\n* \\[Cohort 1\\] H. pylori negative as determined by urea breath test and serum IgG antibody\n* \\[Cohort 2\\] H. pylori positive as determined by urea breath test and serum IgG\n\nExclusion Criteria:\n\n* History of clinically significant gastrointestinal, renal, hepatic, neurologic, hemato-oncologic, endocrine, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease or any other condition, which in the opinion of the investigators, would jeopardize the safety of the subject or impact the validity of the study results\n* History of allergy or hypersensitivity to any drug, including prior serious adverse reaction to PPIs or P-CABs\n* Undergone surgery or in a medical condition, which in the judgment of the PI or investigators may affect absorption, distribution, metabolism or elimination of the study drug\n* Administered other drug(s) in other clinical study within 60 days prior to screening visit\n* Donated blood within 60 days or blood components within 30 days, or had been transfused plasma within 30 days prior to screening visit\n* On special diet or have experienced substantial changes in eating habits within 30 days prior to screening visit\n* Used any prescription medication within 14 days, or any other OTC medications including herbal products within 7 days prior to screening visit\n* Consumed over 21 units/week of alcohol\n* Consumed over 5 units/day of caffeine-containing beverage\n* Positive urine screen for drugs and/or cotinine\n* Positive blood screen for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis\n* Clinically significant abnormalities of liver function tests (≥1.5 fold of normal upper limit in the level of L-alanine aminotransferase (ALT), L-aspartate aminotransferase (AST) or total bilirubin)\n* Unable to bear pH meter catheter insertion\n* History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison syndrome\n* Clinically significant observations considered as unsuitable based on medical judgment by investigators"}, 'identificationModule': {'nctId': 'NCT03009760', 'briefTitle': 'To Investigate Pharmacokinetics and Pharmacodynamics of CJ-12420 After Single and Multiple Dose Administration', 'organization': {'class': 'INDUSTRY', 'fullName': 'HK inno.N Corporation'}, 'officialTitle': 'A Phase I , Study to Investigate Pharmacokinetics and Pharmacodynamics of Single and Multiple Dose of CJ-12420 50mg, 100mg in Helicobacter Pylori ?', 'orgStudyIdInfo': {'id': '[CJ_APA_104]'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CJ-12420 50mg(HP-)', 'description': 'CJ-12420 50mg in H. pylori negative subject', 'interventionNames': ['Drug: CJ-12420 50mg(HP-)']}, {'type': 'EXPERIMENTAL', 'label': 'CJ-12420 100mg(HP-)', 'description': 'CJ-12420 100mg in H. pylori negative subject', 'interventionNames': ['Drug: CJ-12420 100mg(HP-)']}, {'type': 'EXPERIMENTAL', 'label': 'CJ-12420 50mg(HP+)', 'description': 'CJ-12420 50mg in H. pylori positive subject', 'interventionNames': ['Drug: CJ-12420 50mg(HP+)']}, {'type': 'EXPERIMENTAL', 'label': 'CJ-12420 100mg(HP+)', 'description': 'CJ-12420 100mg in H. pylori positive subject', 'interventionNames': ['Drug: CJ-12420 100mg(HP+)']}], 'interventions': [{'name': 'CJ-12420 50mg(HP-)', 'type': 'DRUG', 'otherNames': ['not yet determined'], 'description': 'CJ-12420 50mg in H. pylori negative subject', 'armGroupLabels': ['CJ-12420 50mg(HP-)']}, {'name': 'CJ-12420 100mg(HP-)', 'type': 'DRUG', 'otherNames': ['not yet determined'], 'description': 'CJ-12420 100mg in H. pylori negative subject', 'armGroupLabels': ['CJ-12420 100mg(HP-)']}, {'name': 'CJ-12420 50mg(HP+)', 'type': 'DRUG', 'otherNames': ['not yet determined'], 'description': 'CJ-12420 50mg in H. pylori positive subject', 'armGroupLabels': ['CJ-12420 50mg(HP+)']}, {'name': 'CJ-12420 100mg(HP+)', 'type': 'DRUG', 'otherNames': ['not yet determined'], 'description': 'CJ-12420 100mg in H. pylori positive subject', 'armGroupLabels': ['CJ-12420 100mg(HP+)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HK inno.N Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}