P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants - Trial NCT06079775
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.
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Study Focus
Sponsor & Location
Qpex Biopharma, Inc.
Timeline & Enrollment
Phase 1
Jan 20, 2024
Dec 07, 2024
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
Data Source
ClinicalTrials.gov
NCT06079775
Non-Device Trial