34 Participants Needed

Ceftibuten + Ledaborbactam Pharmacokinetics in Healthy Subjects

VC
Overseen ByVenatorx Clinical Science
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Venatorx Pharmaceuticals, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The available research does not provide specific safety data for humans regarding the combination of ceftibuten and ledaborbactam. The studies focus on the effectiveness of the combination against drug-resistant bacteria, but do not mention safety outcomes in human trials.13678

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

CM

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

Laboratory values meeting defined entry criteria
Body Mass Index: ≥18 and ≤32 kg/m2
Forced expiratory volume in 1 second of at least 80% of predicted value
See 2 more

Exclusion Criteria

History of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug or to medications used during a bronchoscopy
Positive alcohol, drug, or tobacco use/test
I have a condition that affects how my body absorbs or gets rid of medications taken by mouth.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ceftibuten-ledaborbactam etzadroxil or ceftibuten alone, with bronchoscopy and bronchoalveolar lavage after the fifth dose

1 week
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • ceftibuten
  • ledaborbactam
Trial Overview The study is testing how two drugs, ceftibuten and ledaborbactam etzadroxil, are processed in the body (pharmacokinetics) when given to healthy individuals. It involves taking samples from lung fluid and blood after drug administration.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Participants in Group 2 will undergo one standardized bronchoscopy with bronchoalveolar lavage after the fifth of dose of ceftibuten alone.
Group II: Group 1Experimental Treatment2 Interventions
Participants in Group 1 will undergo one standardized bronchoscopy with bronchoalveolar lavage after the fifth dose of ceftibuten-ledaborbactam etzadroxil.

ceftibuten is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Cedax for:
  • Acute bacterial exacerbations of chronic bronchitis
  • Acute bacterial otitis media
  • Pharyngitis and tonsillitis
🇪🇺
Approved in European Union as Ceftibuten for:
  • 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

Trials
15
Recruited
1,200+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

Findings from Research

Ledaborbactam, a novel β-lactamase inhibitor, effectively restores the activity of ceftibuten against ceftibuten-resistant Enterobacterales, as demonstrated in a murine thigh infection model using 12 clinical isolates.
The study quantified the necessary ledaborbactam exposure levels for achieving bacteriostasis, indicating promising potential for the oral combination of ceftibuten and ledaborbactam in treating infections caused by multidrug-resistant bacteria.
In vivo pharmacokinetics and pharmacodynamics of ceftibuten/ledaborbactam, a novel oral β-lactam/β-lactamase inhibitor combination.Fratoni, AJ., Avery, LM., Nicolau, DP., et al.[2023]
Ceftibuten is an effective oral cephalosporin antibiotic with broad activity against key respiratory pathogens, including Streptococcus pneumoniae and Haemophilus influenzae, even those producing beta-lactamases.
A single daily dose of 400 mg for adults or 9 mg/kg for children achieves sufficient blood levels to maintain its antibacterial effects throughout most of the dosing period, indicating its potential for convenient treatment regimens.
Ceftibuten: minimal inhibitory concentrations, postantibiotic effect and beta-lactamase stability--a rationale for dosing programs.Neu, HC.[2018]
Ceftibuten-ledaborbactam etzadroxil is an oral treatment that effectively inhibits 89.7% of multidrug-resistant Enterobacterales at a low concentration (MIC90 of 0.25 μg/mL), showing promise against various resistant strains.
The combination demonstrated high efficacy against specific resistant genotypes, inhibiting 96.3% of CTX-M-9 group isolates and 85.9% of KPC-positive isolates, indicating its potential as a valuable option for treating complicated urinary tract infections caused by resistant bacteria.
Ceftibuten-Ledaborbactam Activity against Multidrug-Resistant and Extended-Spectrum-β-Lactamase-Positive Clinical Isolates of Enterobacterales from a 2018-2020 Global Surveillance Collection.Karlowsky, JA., Wise, MG., Hackel, MA., et al.[2022]

References

In vivo pharmacokinetics and pharmacodynamics of ceftibuten/ledaborbactam, a novel oral β-lactam/β-lactamase inhibitor combination. [2023]
Ceftibuten: minimal inhibitory concentrations, postantibiotic effect and beta-lactamase stability--a rationale for dosing programs. [2018]
Ceftibuten-Ledaborbactam Activity against Multidrug-Resistant and Extended-Spectrum-β-Lactamase-Positive Clinical Isolates of Enterobacterales from a 2018-2020 Global Surveillance Collection. [2022]
Ceftibuten: an overview. [2018]
A descriptive pharmacokinetic/pharmacodynamic analysis of continuous infusion ceftazidime-avibactam for treating DTR gram-negative infections in a case series of critically ill patients undergoing continuous veno-venous haemodiafiltration (CVVHDF). [2023]
In vitro activity of the orally bioavailable ceftibuten/VNRX-7145 (VNRX-5236 etzadroxil) combination against a challenge set of Enterobacterales pathogens carrying molecularly characterized β-lactamase genes. [2022]
In Vitro Activity of Ceftibuten/VNRX-5236 against Urinary Tract Infection Isolates of Antimicrobial-Resistant Enterobacterales. [2022]
Selection of the appropriate avibactam concentration for use with ceftibuten in broth microdilution susceptibility testing. [2022]
Multiple-Dose Pharmacokinetics of Ceftibuten in Healthy Adults and Geriatric Volunteers. [2019]
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