Ceftibuten + Ledaborbactam Pharmacokinetics in Healthy Subjects
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the study is for healthy adults and excludes those with certain health conditions, it's possible that you may need to pause some medications. Please consult with the trial coordinators for specific guidance.
What data supports the effectiveness of the drug ceftibuten-ledaborbactam?
The drug ceftibuten-ledaborbactam has shown effectiveness against multidrug-resistant bacteria, particularly those causing complicated urinary tract infections. It was able to inhibit a high percentage of resistant bacteria in laboratory tests, suggesting it could be a promising option for treating infections that are difficult to manage with other antibiotics.12345
Is the combination of ceftibuten and ledaborbactam safe for humans?
What makes the drug ceftibuten + ledaborbactam unique compared to other treatments for multidrug-resistant Enterobacterales infections?
Ceftibuten + ledaborbactam is unique because it combines an oral antibiotic (ceftibuten) with a novel β-lactamase inhibitor (ledaborbactam) that restores the antibiotic's effectiveness against resistant bacteria, offering a new oral treatment option for complicated urinary tract infections caused by multidrug-resistant Enterobacterales.13689
What is the purpose of this trial?
This is a Phase 1, open-label, single-center PK study in healthy adult male and female participants between 18 and 55 years of age (both inclusive). Thirty-one participants will each undergo one standard bronchoscopy with bronchoalveolar lavage (BAL) following the fifth dose of ceftibuten-ledaborbactam etzadroxil or ceftibuten alone. BAL fluid samples and plasma samples will be collected at designated timepoints to determine the concentrations of ceftibuten, ledaborbactam, and urea.
Research Team
Chief Medical Officer
Principal Investigator
Venatorx Pharmaceuticals, Inc.
Eligibility Criteria
This clinical trial is open to healthy adult men and women aged between 18 and 55. Participants must be willing to undergo a bronchoscopy with bronchoalveolar lavage after receiving doses of the study drugs. Specific eligibility criteria details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ceftibuten-ledaborbactam etzadroxil or ceftibuten alone, with bronchoscopy and bronchoalveolar lavage after the fifth dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ceftibuten
- ledaborbactam
ceftibuten is already approved in United States, European Union for the following indications:
- Acute bacterial exacerbations of chronic bronchitis
- Acute bacterial otitis media
- Pharyngitis and tonsillitis
- Lower respiratory tract infections
- Upper respiratory tract infections
- Urinary tract infections
Find a Clinic Near You
Who Is Running the Clinical Trial?
Venatorx Pharmaceuticals, Inc.
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator