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NCT06157242

P1, Open-label, SAD PK & Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Renal Impairment Pts

A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of ORAvance (Ceftibuten/Xeruborbactam Oral Prodrug [QPX7831]) in Participants With Renal Impairment
Qpex Biopharma, Inc.·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Bacterial Infections
Drug/Device/Intervention
Xeruborbactam Oral Prodrug
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Qpex Biopharma, Inc.
Timeline & enrollment
Phase
Phase 1
Start date
Jun 01, 2024
End date
Jun 01, 2025
Enrollment
32 participants
Primary outcome

Incidence of Treatment Emergent adverse events by subject and by group,Number of patients with changes from baseline in safety parameters,Peak plasma Concentration measurements by subject and by group (Cmax),Time concentration data measurements by subject and by group (Tmax),Area under the plasma concentration versus time curve (AUC) between groups,Urine Pharmacokinetic (PK) amount excreted by subject and by group,Urine Pharmacokinetic (PK) % dose excreted by subject and by group

Summary

A Phase 1, open-label, single-dose study to determine the safety and pharmacokinetics of
 ORAvance (ceftibuten/xeruborbactam oral prodrug [QPX7831]) in participants with renal
 impairment

ICD-10 classifications
Bacterial infection, unspecifiedBacterial, viral and other infectious agentsOther bacterial intestinal infectionsOther bacterial diseasesOther specified bacterial intestinal infections
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06157242
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06157242 through Pure Global AI's free database. This Phase 1 trial is sponsored by Qpex Biopharma, Inc. and is currently Not yet recruiting. The study focuses on Bacterial Infections. Target enrollment is 32 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.