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P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants

NCT06079775 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-12-12

No results posted yet for this study

Summary

A Phase 1, Open-Label, Drug-drug Interaction, and Randomized, Double-blind, Controlled, Multiple-dose Pharmacokinetics and Safety Study of Xeruborbactam Oral Prodrug (QPX7831) in Combination with Ceftibuten in Healthy Adult Participants

Conditions

Interventions

DRUG

Xeruborbactam Oral Prodrug

Experimental

DRUG

Ceftibuten

Experimental

DRUG

Xeruborbactam Oral Prodrug Placebo

Placebo Comparator

DRUG

Ceftibuten Placebo

Placebo Comparator

Sponsors & Collaborators

Principal Investigators

  • Jeff Loutit, MBChB · Qpex Biopharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-30
Primary Completion
2025-01-05
Completion
2025-01-05
FDA Drug
Yes

Countries

  • Australia

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 NCT06079775 on ClinicalTrials.gov