P1, Open-label, SAD PK & Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Renal Impairment Pts - Trial NCT06157242
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.
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Study Focus
Sponsor & Location
Qpex Biopharma, Inc.
Timeline & Enrollment
Phase 1
Jun 01, 2024
Jun 01, 2025
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
Data Source
ClinicalTrials.gov
NCT06157242
Non-Device Trial