Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-05 @ 2:32 PM
Study NCT ID:
NCT02710994
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2016-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacodynamics and Safety of CDFR0209
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013276', 'term': 'Stomach Ulcer'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-12', 'studyFirstSubmitDate': '2016-03-04', 'studyFirstSubmitQcDate': '2016-03-12', 'lastUpdatePostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'Through study completion, an average of 35 days'}], 'primaryOutcomes': [{'measure': 'Mean percent decrease from baseline in integrated gastric acidity after 7th dose', 'timeFrame': 'Day 7 upto 24 hours', 'description': 'Data for 24 hour gastric pH were acquired at baseline (day -1) and day 7 of dosing with either Losec 40 mg or CDFR0209.\n\nPercent decrease from baseline in integrated gastric acidity after 7th dose = \\[Baseline integrated acidity - Day 7 integrated acidity\\]/ Baseline integrated acidity × 100.'}], 'secondaryOutcomes': [{'measure': 'Mean percent decrease from baseline in integrated gastric acidity after 1st dose', 'timeFrame': 'Day 1 upto 24 hours', 'description': 'Data for 24 hour gastric pH were acquired at baseline (day -1) and day 1 of dosing with either Losec 40 mg or CDFR0209.\n\nPercent decrease from baseline in integrated gastric acidity after 1st dose = \\[Baseline integrated acidity - Day 1 integrated acidity\\]/ Baseline integrated acidity × 100.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immediate release omeprazole', 'Integrated gastric acidity'], 'conditions': ['Stomach Ulcer', 'Gastroesophageal Reflux']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, two-way crossover study to investigate the pharmacodynamics(24 hour gastric pH) and the safety between repeated doses of CDFR0209 and Losec in Healthy Male Volunteers', 'detailedDescription': 'Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trial Center of Ajou University Medical Center on the 2 day before dosing (Day -2).\n\nOn Day -1 around 8 AM, ambulatory intragastric pH recording was performed using ZepHr® pH Monitoring System (Sandhill Scientific, Inc., Highlands Ranch, CO, USA) without dosing for 24 hours.\n\nOn Day 1, subjects was dosed Losec 40 mg or CDFR0209 (Omeprazole 40 mg \\& sodium bicarbonate 1,100 mg) around 8 AM and ambulatory intragastric pH recording was continued upto 24 hours after dosing.\n\nFrom Day 2 \\~ 6, subjects were dosed Losec 40 mg or CDFR0209 around 8 AM. On Day 7, subjects was dosed Losec 40 mg or CDFR0209 (Omeprazole 40 mg \\& sodium bicarbonate 1,100 mg) around 8 AM and ambulatory intragastric pH recording was performed upto 24 hours after dosing.\n\nAfter 14 days of washout period, subjects was dosed Losec 40 mg or CDFR0209 by crossover manner and ambulatory intragastric pH recording was performed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male subjects aged 20 - 45 years\n* With in 20% of ideal body weight, {Ideal body weight=\\[height(cm)-100\\]\\*0.9}\n* Agreement with written informed consent\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)\n* Inadequate result of laboratory test (especially, AST/ALT \\> 1.25 x UNL, Total bilirubin \\> 1.5 x UNL)\n* Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test and Helicobacter Ab IgM\n* Positive result in urea breath test\n* Taking OTC(Over the counter)medicine including oriental medicine within 7 days\n* Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)\n* Subject with known for hypersensitivity reaction to omeprazole and sodium bicarbonate\n* Previous whole blood donation within 60 days or component blood donation within 30 days\n* Previous participation of other trial within 90 days\n* Continued taking caffeine (caffeine \\> 5 cup/day), drinking (alcohol \\> 30 g/day) and severe heavy smoker (cigarette \\> 1/2 pack per day)\n* An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result"}, 'identificationModule': {'nctId': 'NCT02710994', 'briefTitle': 'Pharmacodynamics and Safety of CDFR0209', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'A Randomized, Open Label, Two-way Crossover Designed Clinical Trial to Investigate the Pharmacodynamics and the Safety Between Repeated Doses of CDFR0209 in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'MED-CT1-14-085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CDFR0209, Then Losec', 'description': 'Subjects first received CDFR0209 each morning in a fasting state for 7 days. After a washout period of 14 days, they then received Losec 40 mg in a fasting state each morning for 7 days.', 'interventionNames': ['Drug: CDFR0209', 'Drug: Losec']}, {'type': 'EXPERIMENTAL', 'label': 'Losec, Then CDFR0209', 'description': 'Subjects first received Losec 40 mg each morning in a fasting state for 7 days. After a washout period of 14 days, they then received CDFR0209 in a fasting state each morning for 7 days.', 'interventionNames': ['Drug: CDFR0209', 'Drug: Losec']}], 'interventions': [{'name': 'CDFR0209', 'type': 'DRUG', 'description': 'Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg', 'armGroupLabels': ['CDFR0209, Then Losec', 'Losec, Then CDFR0209']}, {'name': 'Losec', 'type': 'DRUG', 'description': 'Losec 40 mg', 'armGroupLabels': ['CDFR0209, Then Losec', 'Losec, Then CDFR0209']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443-380', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou University Medical Center', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Doo-Yeoun Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'CTC Bio, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Doo-Yeoun Cho', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}