Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-03 @ 8:46 AM
Study NCT ID:
NCT01751269
Status:
COMPLETED
Last Update Posted:
2013-07-24
First Post:
2012-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects
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': 'C000599945', 'term': 'RPX7009'}, {'id': 'D065093', 'term': 'beta-Lactamase Inhibitors'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-22', 'studyFirstSubmitDate': '2012-12-13', 'studyFirstSubmitQcDate': '2012-12-14', 'lastUpdatePostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety from baseline through the end of the study.', 'timeFrame': 'Study Day 1 to Day 13.', 'description': 'Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.'}], 'secondaryOutcomes': [{'measure': 'Composite of PK parameters RPX7009 & placebo following single dose administration.', 'timeFrame': 'Study Day 1 to Day 12', 'description': 'Plasma AUC0-t, AUC0-inf, Cmax, and Tmax.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'Bacterial Infections']}, 'referencesModule': {'references': [{'pmid': '27527080', 'type': 'DERIVED', 'citation': 'Griffith DC, Loutit JS, Morgan EE, Durso S, Dudley MN. Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of the beta-Lactamase Inhibitor Vaborbactam (RPX7009) in Healthy Adult Subjects. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6326-32. doi: 10.1128/AAC.00568-16. Print 2016 Oct.'}]}, 'descriptionModule': {'briefSummary': 'RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem to treat bacterial infections, including those due to multi-drug resistant bacteria.', 'detailedDescription': 'The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the recent dissemination of a serine carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.\n\nRempex is developing a fixed combination antibiotic of a carbapenem plus a new beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases, including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics of RPX7009, administered alone, in healthy adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult males and/or females (of Non Child-bearing potential), 18 to 55 years of age\n* Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).\n* Medically healthy with clinically insignificant screening results\n* Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day 1.\n* Sexually abstinent or use acceptable methods of birth control\n\nExclusion Criteria:\n\n* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.\n* History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.\n* Documented hypersensitivity reaction or anaphylaxis to any medication.\n* Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.\n* Plasma donation within 7 days prior to Day 1.\n* Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).'}, 'identificationModule': {'nctId': 'NCT01751269', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects.', 'orgStudyIdInfo': {'id': 'Rempex 402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ascending Single and Multiple dose of RPX7009', 'description': 'Ascending Single and Multiple dose of RPX7009', 'interventionNames': ['Drug: RPX7009']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Ascending Single and multiple dose of normal saline.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RPX7009', 'type': 'DRUG', 'otherNames': ['(beta-lactamase inhibitor)'], 'description': 'Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.', 'armGroupLabels': ['Ascending Single and Multiple dose of RPX7009']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'description': 'Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'CMAX', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Jefferey Loutit, MBChB', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}