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NCT06079775

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

A Phase 1, Randomized, Double-blind, Controlled, Drug-drug Interaction and Multiple-dose Pharmacokinetics and Safety Study of Xeruborbactam Oral Prodrug (QPX7831) in Combination With Ceftibuten in Healthy Adult Participants
Qpex Biopharma, Inc.·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
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
Jan 20, 2024
End date
Dec 07, 2024
Enrollment
72 participants
Primary outcome

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

Summary

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

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
NCT06079775
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06079775 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 72 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.