NCT07104162

A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment

A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam (S-649228) in Participants With Renal Impairment

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Qpex Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam (S-649228) in Participants with Renal Impairment

Detailed description

Qpex Biopharma, Inc., a wholly owned subsidiary of Shionogi Inc., is developing a fixed combination antibiotic of cefiderocol, a cephalosporin antibiotic approved in the US for the treatment of complicated urinary tract infections (cUTIs) including pyelonephritis, and hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), plus an investigational broad-spectrum beta-lactamase inhibitor (BLI), xeruborbactam (QPX7728) to address the need for new antibiotics for the pathogens deemed as urgent or critical threats. The aim of this study is to compare single-dose intravenous (IV) pharmacokinetics (PK) and safety of the combination of cefiderocol/xeruborbactam (S-649228) in participants with various degrees of stable renal impairment, including those with end-stage renal disease (ESRD), to control participants with normal renal function. The results from this study will enable the development of appropriate dosing recommendations in patients with impaired renal function. Objectives: The objectives of the study are: 1. To assess the impact of mild, moderate, and severe renal impairment, and intermittent hemodialysis (IHD) on the PK of IV cefiderocol and IV xeruborbactam given to participants with stable renal impairment, normal renal function, and ESRD receiving IHD therapy. 2. To evaluate the safety and tolerability of IV cefiderocol and IV xeruborbactam given to participants with stable renal impairment, normal renal function, and ESRD receiving IHD therapy.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	Cefiderocol/Xeruborbactam	A fixed dose combination of intravenous cefiderocol and intravenous xeruborbactam

Timeline

• Start date: 2025-09-16
• Primary completion: 2026-07-30
• Completion: 2026-12-23
• First posted: 2025-08-05
• Last updated: 2025-11-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study