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drugset / Trial / NCT07083817

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

NCT07083817 ↗

Phase 1 Completed 8 enrolled Qpex Biopharma, Inc. Shionogi · collab
NaSingle-groupOpen-labelOther

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.

Timeline

Start
2025-08-13
Primary completion
2025-08-27
Completion
2025-08-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Xeruborbactam Small molecule — Intravenous

Indications

No indication recorded.