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Phase 1 Study of Intravenous Cefiderocol and Xeruborbactam to Evaluate Safety and Drug Levels in Adults With Various Levels of Kidney Impairment
Led by Qpex Biopharma, Inc. · Updated on 2025-11-25
40
Participants Needed
2
Research Sites
20 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the safety and pharmacokinetics of a fixed intravenous combination of cefiderocol and xeruborbactam in adults with different levels of stable kidney impairment, including those with end-stage renal disease ESRD on intermittent hemodialysis IHD. This Phase 1, open-label, single-dose study aims to understand how kidney function affects the drugs behavior in the body to help develop dosing recommendations for patients with kidney problems. Participants will receive a single intravenous dose of cefiderocolxeruborbactam on Day 1. Approximately 40 people will be divided into five groups based on kidney function mild, moderate, or severe renal impairment, healthy participants with normal kidney function, and those with ESRD receiving IHD. Each group will receive the study drug to assess differences in drug levels and safety. During the study, participants will be monitored for up to 11 to 22 days for any treatment-emergent side effects and changes in safety tests. Researchers will measure drug levels in blood plasma and urine, including the amount removed by dialysis. Participants will undergo clinical exams, laboratory tests, and safety assessments to track the drugs effects and tolerability throughout the follow-up period.
CONDITIONS
Brief Title
A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment
Research Team
G
Grigor Mamikonyan, PharmD,PhD
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