Viewing Study NCT05072444



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Last Modification Date: 2024-10-26 @ 2:15 PM
Study NCT ID: NCT05072444
Status: COMPLETED
Last Update Posted: 2022-10-10
First Post: 2021-09-28

Brief Title: Drug-Drug Interaction Study of IV QPX2014 Combined With QPX7728 in Healthy Adult Subjects
Sponsor: Qpex Biopharma Inc
Organization: Qpex Biopharma Inc

Study Overview

Official Title: A Phase 1 Randomized Double-Blind Single-Dose Drug-Drug Interaction Study to Determine the Impact of Co-administration of QPX7728 on the Pharmacokinetics of QPX2014 in Healthy Adult Subjects
Status: COMPLETED
Status Verified Date: 2022-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor with activity against numerous beta-lactamases including class A extended spectrum betalactamases ESBLs class C cephalosporinases and extended spectrum class D oxacillinases OXA that can hydrolyze cephalosporins and can be found in Enterobacteriaceae and Pseudomonas aeruginosa P aeruginosa QPX7728 is also a potent inhibitor of carbapenemases from all molecular classes such as class A Klebsiella pheumoniae carbapenemase KPC class B New-Dehli Metalo-beta-lactamase NDM and Verona integron-encoded metallo-betalactamase VIM and class D OXA-48 that are found in carbapenem resistant Enterobacteriaceae and also class D carbapenemases such as OXA-23 that are found in carbapenem resistant Acinetobacter baumannii
Detailed Description: The Centers for Disease Control CDC has listed carbapenem-resistant Enterobacteriaceae and Acinetobacter as urgent threats and multidrug resistant Pseudomonas and extended spectrum beta-lactamase ESBL-producing Enterobacteriaceae as serious threats CDC 2019 Consistent with the global nature of these resistant bacteria the World Health Organization WHO has designated carbapenem-resistant ESBL-producing Enterobacteriaceae carbapenem-resistant Acinetobacter baumannii and carbapenem-resistant Pseudomonas aeruginosa as pathogens for which new agents are critically needed WHO 2017 Qpex Biopharma is developing a fixed combination antibiotic of QPX2014 plus an ultra-broad spectrum beta-lactamase inhibitor QPX7728

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None