Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-18 @ 10:03 PM
Study NCT ID:
NCT01520012
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2012-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625316', 'term': 'YH4808'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-23', 'studyFirstSubmitDate': '2012-01-13', 'studyFirstSubmitQcDate': '2012-01-24', 'lastUpdatePostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve of YH4808', 'timeFrame': 'Blood sampling during 24 or 48 hrs after administration', 'description': 'non-compartmental analysis'}, {'measure': 'Peak plasma concentration of YH4808', 'timeFrame': 'Blood sampling during 24 or 48 hrs after administration', 'description': 'non-compartmental analysis'}], 'secondaryOutcomes': [{'measure': 'Time to reach peak plasma concentration of YH4808', 'timeFrame': 'Blood sampling during 24 or 48 hrs after administration', 'description': 'non-compartmental analysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29907887', 'type': 'DERIVED', 'citation': 'Kim E, Kim A, Yi S, Kim YK, Jang SB, Byun HM, Yoon SH, Cho JY, Jang IJ, Yu KS, Lee S. Effect of food on the pharmacokinetics of YH4808, a potassium-competitive acid blocker, after single- and multiple-oral dosing in healthy subjects. Eur J Clin Pharmacol. 2018 Oct;74(10):1261-1272. doi: 10.1007/s00228-018-2502-9. Epub 2018 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808 100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug\n* Healthy male volunteers in the age between 20 to 45 years old\n* Weight: over 50kg, within ±20% of ideal body weight\n* Subjects who were determined to be appropriate through screening\n\nExclusion Criteria:\n\n* Clinically significant disorder in liver, kidney, cardiovascular, respiratory system, endocrine system and CNS in the physical examination and clinical laboratory tests or a medical history of malignant tumor or psychological disease\n* Medical history of gastrointestinal disease or acid restraining surgery, gastric/esophagus surgery (excluding appendectomy, hernia surgery)\n* A history of hypersensitivity to drugs or clinically significant allergic disease\n* Clinically significant abnormal values in blood chemistry(≥ 1.5 fold of normal upper limit in the levels of SGOT, SGPT)\n* Subjects who had a history of drug abuse or who had a positive results on urine drug screening\n* Subjects who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment(cf, be able to be enrolled in this study according to an investigatory consideration)\n* Subjects who participated in another clinical trial within 2 months before enrolling in this study\n* Subjects who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment\n* Subjects who drank Over 21 units/week of alcohol or subjects who were unable to stop drinking alcohol during the hospitalization\n* Subjects who stopped smoking within 3 months before the treatment\n* Subjects who had a beverage containing grapefruits within 24hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization\n* Subjects who had a beverage containing caffeine during the hospitalization\n* Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators'}, 'identificationModule': {'nctId': 'NCT01520012', 'briefTitle': 'Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'Clinical Trial to Investigate the Influence of Food on Safety/Tolerability and Pharmacokinetics of YH4808 After Oral Administration in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'YH4808-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'interventionNames': ['Drug: YH4808 100 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'interventionNames': ['Drug: YH4808 100 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'interventionNames': ['Drug: YH4808 300 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'interventionNames': ['Drug: YH4808 300 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 5', 'interventionNames': ['Drug: YH4808 300 mg']}], 'interventions': [{'name': 'YH4808 100 mg', 'type': 'DRUG', 'description': 'Period1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days', 'armGroupLabels': ['Sequence 1']}, {'name': 'YH4808 100 mg', 'type': 'DRUG', 'description': 'Period1: YH4808 100 mg bid fed condition for 7days Period2: YH4808 100 mg bid fasting condition for 7days', 'armGroupLabels': ['Sequence 2']}, {'name': 'YH4808 300 mg', 'type': 'DRUG', 'description': 'Period1: YH4808 300 mg fasting condition Period2: YH4808 300 mg fed condition(standard meal) Period3: YH4808 300 mg fed condition(high fat meal)', 'armGroupLabels': ['Sequence 3']}, {'name': 'YH4808 300 mg', 'type': 'DRUG', 'description': 'Period1: YH4808 300 mg fed condition(high fat meal) Period2: YH4808 300 mg fasting condition Period3: YH4808 300 mg fed condition(standard meal)', 'armGroupLabels': ['Sequence 4']}, {'name': 'YH4808 300 mg', 'type': 'DRUG', 'description': 'Period1: YH4808 300 mg fed condition(standard meal) Period2: YH4808 300 mg fed condition(high fat meal) Period3: YH4808 300 mg fasting condition', 'armGroupLabels': ['Sequence 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-754', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yuhan Corporation', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung-Sang Yu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}