Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-25 @ 3:01 AM
Study NCT ID:
NCT02134834
Status:
COMPLETED
Last Update Posted:
2014-12-12
First Post:
2014-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608518', 'term': 'nacubactam'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-11', 'studyFirstSubmitDate': '2014-05-07', 'studyFirstSubmitQcDate': '2014-05-07', 'lastUpdatePostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety from baseline through the end of the study', 'timeFrame': 'Day 1 to Day 7', 'description': 'Number of patients with adverse events'}], 'secondaryOutcomes': [{'measure': 'Plasma PK parameters of OP0595 and its metabolites', 'timeFrame': 'Day 1 to Day 2', 'description': 'Cmax, tmax, AUC0-last, AUC0-inf, Kel, T1/2, CLtot, Vdss'}, {'measure': 'Urine PK parameters of OP0595 and its metabolites', 'timeFrame': 'Day 1 to Day 2', 'description': 'Ae, Ae0-t, Ae0-t/Dose, CLr'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'Bacterial Infections']}, 'referencesModule': {'references': [{'pmid': '32041717', 'type': 'DERIVED', 'citation': 'Mallalieu NL, Winter E, Fettner S, Patel K, Zwanziger E, Attley G, Rodriguez I, Kano A, Salama SM, Bentley D, Geretti AM. Safety and Pharmacokinetic Characterization of Nacubactam, a Novel beta-Lactamase Inhibitor, Alone and in Combination with Meropenem, in Healthy Volunteers. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02229-19. doi: 10.1128/AAC.02229-19. Print 2020 Apr 21.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to assess the safety, tolerability and pharmacokinetic profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at single escalating doses.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian males aged between 18 and 45 years (inclusive) at Screening\n* A Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening\n* Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests\n* Negative urine test for drugs of abuse and breath test for alcohol both at Screening and Day -1\n\nExclusion Criteria:\n\n* Receipt of any investigational agent or drug within four months before Screening\n* A history or current evidence of allergic symptoms such as bronchial asthma, drug-induced rash or urticaria\n* Hypersensitivity and/or allergy to drugs\n* Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders\n* A history of chronic or recurrent infections or current active infection\n* A recent history of surgery within three months prior to Screening, determined by the Investigator to be clinically relevant\n* A history or presence of malignancy\n* Donation of blood (or loss of blood) greater than 400 ml within three months before Screening\n* A history of smoking at any time within one year before Screening'}, 'identificationModule': {'nctId': 'NCT02134834', 'briefTitle': 'A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595', 'organization': {'class': 'INDUSTRY', 'fullName': 'Meiji Seika Pharma Co., Ltd.'}, 'officialTitle': 'A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of OP0595 Administered Intravenously in Healthy Male Subjects.', 'orgStudyIdInfo': {'id': 'OP0595-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ascending single dose of OP0595', 'interventionNames': ['Drug: OP0595']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'OP0595', 'type': 'DRUG', 'description': 'Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation', 'armGroupLabels': ['Ascending single dose of OP0595']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Mitsuharu Egawa', 'role': 'STUDY_CHAIR', 'affiliation': 'Meiji Seika Pharma Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meiji Seika Pharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}