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PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment

NCT06157242 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-05-14

No results posted yet for this study

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

Conditions

Interventions

DRUG

Xeruborbactam Oral Prodrug

Experimental

DRUG

Ceftibuten

Experimental

Sponsors & Collaborators

Principal Investigators

  • Jeff Loutit, MBChB · Qpex Biopharma, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-10
Primary Completion
2025-03-31
Completion
2025-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT06157242 on ClinicalTrials.gov