NCT07083817

Mass Balance Study of [14C]Xeruborbactam (QPX7728) in Healthy Adult Male Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Qpex Biopharma, Inc. · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-dose, phase 1 open-label study to determine the mass balance recovery and metabolic profiling and identification for intravenous (IV) administered \[14C\]xeruborbactam. This study will investigate the primary route of excretion, profile \[14C\]xeruborbactam metabolites in plasma, urine and faeces, and assess the safety, tolerability, and pharmacokinetics (PK) of a single IV dose of \[14C\]xeruborbactam in healthy adult male participants.

Conditions

• ADME

Interventions

Type	Name	Description
DRUG	[14C]Xeruborbactam	Carbon Radiolabeled Xeruborbactam

Timeline

• Start date: 2025-08-13
• Primary completion: 2025-08-27
• Completion: 2025-08-27
• First posted: 2025-07-24
• Last updated: 2025-08-29

Locations

1 site across 1 country: United Kingdom