Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-03-12 @ 12:54 AM
Study NCT ID:
NCT02538003
Status:
COMPLETED
Last Update Posted:
2016-03-23
First Post:
2015-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Effect of Food on Pharmacokinetics(PK), Phase I Clinical Study of LCB01-0371
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627008', 'term': 'delpazolid'}]}}, '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': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-22', 'studyFirstSubmitDate': '2015-08-27', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse events', 'timeFrame': 'From date of randomization until follow up after 7 days from last hospital discharge'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: AUClast(Area under the plasma concentration)', 'timeFrame': '0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours'}, {'measure': 'Pharmacokinetics: Cmax(Peak plasma concentration)', 'timeFrame': '0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess safety, tolerability of LCB01-0371 after fasting/non-fasting food taken in healthy male subjects.', 'detailedDescription': 'A Randomized, Open-label, Single dose, Crossover, Phase Ⅰ Trial to evaluate the effect of food on the pharmacokinetics of LCB01-0371 in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy male between 20 and 40 years of age at the time of screening with body mass index (BMI) between 19 kg/m2 and 28 kg/m2 at the time of screening\n2. Appropriated for a medical examination by interview,Vital sign,physical examination, local laboratory test result and 12-lead ECG\n3. Capable of performing follow up visit, blood sampling\n4. Agree to continue to use a medically reliable dual contraception and not to donate sperm in this protocol for the duration of the study and for 28 days after last dose of investigational product\n5. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements\n\nExclusion Criteria:\n\n1. History of clinically significant disease such as digestive system, respiratory, musculoskeletal, cardiovascular, endocrine, neuropsychiatry, hematology, cardiovascular system\n2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 180 days possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)\n3. History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics(except non active allergic rhinitis)\n4. History of drug abuse or positive result at urine drug screening test at screening visit\n5. Intake drug which expected to chronic influence of drug absorption or elimination within 30 days prior to screening visit\n6. Other: Patients considered unable perform for the study by the investigator concerning"}, 'identificationModule': {'nctId': 'NCT02538003', 'briefTitle': 'To Evaluate the Effect of Food on Pharmacokinetics(PK), Phase I Clinical Study of LCB01-0371', 'organization': {'class': 'INDUSTRY', 'fullName': 'LigaChem Biosciences, Inc.'}, 'officialTitle': 'A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Effect of Food on the Pharmacokinetics of LCB01-0371 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'LCB01-0371-13-1-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1(RT):LCB01-0371 Tablet 800mg', 'description': '1. Period:LCB01-0371 Tablet 800mg(Reference: Taken drug before meal)\n2. Period: LCB01-0371 Tablet 800 mg(Test: Taken drug after meal)', 'interventionNames': ['Drug: LCB01-0371 Tablet 800 mg(R)', 'Drug: LCB01-0371 Tablet 800 mg(T)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2(TR):LCB01-0371 Tablet 800mg', 'description': '1. Period:LCB01-0371 Tablet 800mg(Test:taken drug after meal)\n2. Period: LCB01-0371 Tablet 800 mg(Reference:taken drug before meal)', 'interventionNames': ['Drug: LCB01-0371 Tablet 800 mg(R)', 'Drug: LCB01-0371 Tablet 800 mg(T)']}], 'interventions': [{'name': 'LCB01-0371 Tablet 800 mg(R)', 'type': 'DRUG', 'otherNames': ['LCB01-0371 Tablet 400 mg 2 Tablet'], 'description': 'Reference: taken drug before meal', 'armGroupLabels': ['Group 1(RT):LCB01-0371 Tablet 800mg', 'Group 2(TR):LCB01-0371 Tablet 800mg']}, {'name': 'LCB01-0371 Tablet 800 mg(T)', 'type': 'DRUG', 'otherNames': ['LCB01-0371 Tablet 400 mg 2 Tablet'], 'description': 'Test: taken drug after meal', 'armGroupLabels': ['Group 1(RT):LCB01-0371 Tablet 800mg', 'Group 2(TR):LCB01-0371 Tablet 800mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bundang', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital'}], 'overallOfficials': [{'name': 'Jaeyong Chung, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LigaChem Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}