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P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
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.
Study details:
Qpex Biopharma, Inc. is developing an oral dosage form that delivers Xeruborbactam, a new boron-based beta-lactamase inhibitor with activity against both serine and metallo-beta-lactamases, for oral treatment in combination with a beta-lactam antibiotic. Ceftibuten is a cephalosporin antibiotic approved in the US for acute exacerbations of chronic bronchitis, acute bacterial otitis media and pharyngitis/tonsillitis.
This Phase 1 study will assess if a PK interaction exists between xeruborbactam oral prodrug and ceftibuten when given in combination at doses of each drug that have previously been shown to be safe. The study will also assess the safety of the combination with dosing over 10 days. Study Objectives:.
1. To assess the safety, tolerability, and PK of single and multiple doses of xeruborbactam oral prodrug and ceftibuten both in combination and alone, in healthy adult participants. 2.
To assess whether there is any PK interaction between xeruborbactam oral prodrug and ceftibuten when administered in combination to healthy adult participants.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-01-30
Primary completion: 2024-09-12
Study completion finish: 2024-12-07
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06079775
Intervention or treatment
DRUG: Xeruborbactam Oral Prodrug
DRUG: Ceftibuten
DRUG: Xeruborbactam Oral Prodrug Placebo
DRUG: Ceftibuten Placebo
Conditions
- • Bacterial Infections
Find a site
Closest Location:
CMAX
Research sites nearby
Select from list below to view details:
CMAX
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Single Dose Drug-Drug-Interaction Crossover & Multiple Dose Cohorts
| DRUG: Xeruborbactam Oral Prodrug
|
PLACEBO_COMPARATOR: Placebo Comparator to maintain the blind
| DRUG: Xeruborbactam Oral Prodrug Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence of Treatment -Emergent Adverse events by subject and by cohort (single dose, multiple doses) | Number of patients with Treatment-Emergent Adverse Events by subject, by cohort, severity and relationship to treatment | 16 days |
Number of patients with changes from baseline in safety parameters | Number of patients with changes in safety parameters before and after dosing by subject and cohort | 16 days |
Peak plasma Concentration measurements by subject and by cohort (Cmax) | Comparison will be performed between the cohorts for concentration measurements (Cmax). Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed. | 16 days |
Time concentration data measurements by subject and by cohort (Tmax) | Comparison will be performed between the cohorts for time concentration data measurements (Tmax) | 16 days |
Area under the plasma concentration versus time curve (AUC) between cohorts | Comparison will be performed between the cohorts for area under the plasma concentration versus time curve (AUC). Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed. | 16 days |
Urine Pharmacokinetic (PK) amount excreted by subject and by cohort | Urine Pharmacokinetic (PK) parameters such as amount excreted will be calculated from urinary excretion data | 16 days |
Urine Pharmacokinetic (PK) % dose excreted by subject and by cohort | Urine Pharmacokinetic (PK) parameters such as amount of % dose excreted will be calculated from urinary excretion data | 16 days |
Secondary outcome
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