NCT05072444

Drug-Drug Interaction Study of IV QPX2014 Combined With QPX7728 in Healthy Adult Subjects

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
Qpex Biopharma, Inc.·Phase 1·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov
Study focus
Disease/Condition
Bacterial Infections
Drug/Device/Intervention
QPX7728
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Qpex Biopharma, Inc.
Location
Cypress, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Nov 15, 2021
End date
Nov 23, 2021
Enrollment
12 participants
Primary outcome

Area under the plasma concentration versus time curve (AUC) between dosing groups,Peak plasma Concentration measurements by subject and by dosing group,Urine Pharmacokinetic (PK) amount excreted by subject and by dosing group,Urine PK % dose excreted by subject and by dosing group,Incidence of Treatment -Emergent Adverse events (AEs) by subject and by dosing group,Number of patients with changes from baseline in safety parameters

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.

ICD-10 classifications
Bacterial infection, unspecifiedBacterial, viral and other infectious agentsOther bacterial intestinal infectionsOther bacterial diseasesOther specified bacterial intestinal infections
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05072444
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05072444 through Pure Global AI's free database. This Phase 1 trial is sponsored by Qpex Biopharma, Inc. and is currently Completed. The study focuses on Bacterial Infections. Target enrollment is 12 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.