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

NCT07083817 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-08-29

No results posted yet for this study

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

DRUG

[14C]Xeruborbactam

Carbon Radiolabeled Xeruborbactam

Sponsors & Collaborators

  • Shionogi Inc.

    collaborator INDUSTRY

  • Qpex Biopharma, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07083817 on ClinicalTrials.gov