Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-28 @ 3:34 AM
Study NCT ID:
NCT01554995
Status:
COMPLETED
Last Update Posted:
2014-11-17
First Post:
2012-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627008', 'term': 'delpazolid'}, {'id': 'D000069349', 'term': 'Linezolid'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2012-03-09', 'studyFirstSubmitQcDate': '2012-03-13', 'lastUpdatePostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety and tolerability', 'timeFrame': '7 days', 'description': 'Summary statistics for SAD parts will be prepared for measured values and changes from baseline values for each dose group. Placebo subjects will serve as the control. Summaries of treatment-emergent and clinically important abnormalities in ECG, physical examination, vital signs, and laboratory (clinical chemistry, hematology, coagulation, urinalysis) data will be provided. The incidence of adverse events(AEs) will be tabulated and compared across dose group in the SAD parts.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['LCB01-0371'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29712654', 'type': 'DERIVED', 'citation': 'Cho YS, Lim HS, Lee SH, Cho YL, Nam HS, Bae KS. Pharmacokinetics, Pharmacodynamics, and Tolerability of Single-Dose Oral LCB01-0371, a Novel Oxazolidinone with Broad-Spectrum Activity, in Healthy Volunteers. Antimicrob Agents Chemother. 2018 Jun 26;62(7):e00451-18. doi: 10.1128/AAC.00451-18. Print 2018 Jul.'}]}, 'descriptionModule': {'briefSummary': 'Primary\n\n\\- To investigate the safety and tolerability of LCB01-0371 after a single oral dose\n\nSecondary\n\n* To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral dose\n* To investigate the safety of LCB01-0371 after a single oral dose', 'detailedDescription': '* To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral dose\n* To investigate the safety of LCB01-0371 after a single oral dose'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy Male between 20 and 45 years of age at the time of screening\n2. Subjects with body mass index (BMI) between 20 and 27 at the time of screening\n3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days of study completion\n4. 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 liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).\n2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption within 6 months from screening\n3. History of hypersensitivity or clinically significant adverse drug reaction(s) to the LCB01-0371, same class of the study drugs (linezolid), or other drugs including aspirin and antibiotics.\n4. History of drug abuse or positive result at urine drug screening test\n5. AST, ALT, r-GT, billirubin(total) values over than 1.5 times of ULN"}, 'identificationModule': {'nctId': 'NCT01554995', 'briefTitle': 'A Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'LigaChem Biosciences, Inc.'}, 'officialTitle': 'A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCB01-0371 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'LCB01-0371-11-1-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LCB01-0371', 'description': 'active', 'interventionNames': ['Drug: LCB01-0371']}, {'type': 'EXPERIMENTAL', 'label': 'Linezolid', 'description': 'comparator', 'interventionNames': ['Drug: Linezolid']}], 'interventions': [{'name': 'LCB01-0371', 'type': 'DRUG', 'description': 'LCB01-0371 50mg (Cohort 1) 100mg (Cohort 2) 200mg (Cohort 3) 400mg (Cohort 4) 600mg (Cohort 5)', 'armGroupLabels': ['LCB01-0371']}, {'name': 'Linezolid', 'type': 'DRUG', 'description': 'Linezolid 600 mg (Cohort 9) none', 'armGroupLabels': ['Linezolid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyun-Seop Bae, M.D., Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LigaChem Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}