Phase I mass balance and ADME study of [14C]Xeruborbactam (QSC300833)
Research type
Research Study
Full title
A single-dose, phase 1, open-label study to evaluate the mass balance and absorption, distribution, metabolism, and excretion of [14C]xeruborbactam (QPX7728) following administration of a solution for intravenous infusion in healthy adult male participants
IRAS ID
1011544
Contact name
Lynn Connolly
Contact email
Sponsor organisation
Qpex Biopharma, Inc.
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, xeruborbactam, as a potential treatment for bacterial infections, such as hospital acquired bacterial pneumonia (HABP), ventilator associated bacterial pneumonia (VABP) and complicated urinary tract infections (cUTIs). The test medicine is an antibiotic and is being developed to treat these infections when combined with other antibiotic treatments. Specifically, the test medicine aims to target infections caused by bacteria resistant to currently available treatments.
In this study, we’ll give healthy volunteers a single intravenous dose of test medicine to find out how the body breaks down and gets rid of the test medicine. The test medicine will be ‘radiolabelled’ - it will contain a small amount of radioactivity (Carbon-14) - so that we can track it in the body.
In this study in healthy volunteers, we aim to answer these questions.
* Does the test medicine cause any important side effects?
* What are the blood levels of the test medicine and how quickly does the body get rid of it?
* How does the body break down and get rid of the test medicine?This study will take place at 1 site in Nottingham.
We plan to enrol 8 healthy men aged 30-65 years.
Volunteers will receive a single dose of radiolabelled test medicine, by slow injection into a vein. They’ll stay in the clinic for up to 14 nights, and take up to 5 weeks to finish the study.
We’ll collect blood and urine samples to do safety tests. Over a period of at least 10 days, we’ll take many blood samples and volunteers will collect all their urine and faeces so that we can measure the amount of test medicine and its breakdown products.
REC name
Wales REC 2
REC reference
25/WA/0126
Date of REC Opinion
11 Jul 2025
REC opinion
Further Information Favourable Opinion