46 Participants Needed

Ceftibuten-ledaborbactam Etzadroxil for 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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 and 43 days for Part 2. All participants will be screened within 28 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy adults, it's possible that taking certain medications might exclude you from participating. It's best to discuss your specific medications with the trial organizers.

Is Ceftibuten-ledaborbactam Etzadroxil safe for humans?

Ceftibuten, a component of the combination, has a favorable safety profile similar to other cephalosporins, with few adverse reactions reported in studies. However, specific safety data for the combination with ledaborbactam etzadroxil in humans is not detailed in the available research.12345

What makes the drug ceftibuten-ledaborbactam etzadroxil unique?

Ceftibuten-ledaborbactam etzadroxil is unique because it combines a cephalosporin antibiotic with a novel beta-lactamase inhibitor, ledaborbactam, to effectively treat complicated urinary tract infections caused by multidrug-resistant bacteria. This combination is taken orally, offering a convenient option compared to other treatments that may require intravenous administration.13456

What data supports the effectiveness of the drug ceftibuten-ledaborbactam etzadroxil?

Research shows that ceftibuten-ledaborbactam etzadroxil is effective against many drug-resistant bacteria, including those causing complicated urinary tract infections. It was able to inhibit a high percentage of multidrug-resistant bacteria in lab tests, suggesting it could be a promising treatment option.12478

Who Is on the Research Team?

CM

Chief Medical Officer

Principal Investigator

Venatorx Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-55 with a BMI between 18 and 32 kg/m2. Participants must have lab values within specific ranges and cannot be pregnant or breastfeeding. The study excludes anyone not meeting these health criteria.

Inclusion Criteria

I am a male or a female not pregnant or breastfeeding.
Body mass index ≥ 18 and ≤ 32 kg/m2
Laboratory values meeting defined laboratory ranges

Exclusion Criteria

Positive alcohol, drug or tobacco use/test
History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug
I haven't had any significant illness or surgery in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment Part 1

Participants receive a single oral dose of ceftibuten and ledaborbactam etzadroxil in different sequences

11 days
In-patient stay at CRU

Treatment Part 2

Participants receive oral doses of Ceftibuten-ledaborbactam etzadroxil as fixed-dose capsules for 7 days

7 days
In-patient stay at CRU

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Ceftibuten-ledaborbactam Etzadroxil
Trial Overview The study tests a fixed-dose combination of Ceftibuten-ledaborbactam etzadroxil, comparing it to Ledaborbactam etzadroxil, Ceftibuten, and Esomeprazole alone. It's designed to assess safety and how the body processes these drugs in two parts over roughly six weeks.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Part 2 Group 3Experimental Treatment1 Intervention
Part 2 Group 3 will possibly enroll 10 participants. Following availability of PK and safety data from Groups 1 and 2, a determination will be made regarding whether or not Group 3 is needed and the dosing conditions that apply
Group II: Part 2 Group 2Experimental Treatment1 Intervention
Part 2 Group 2 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil as fixed-dose capsules for 7 days (Fed Group)
Group III: Part 2 Group 1Experimental Treatment1 Intervention
Part 2 Group 1 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil as fixed-dose capsules for 7 days (Fasted Group)
Group IV: Part 1Experimental Treatment4 Interventions
Part 1 will enroll at least 16 participants who will receive a single oral dose of ceftibuten and ledaborbactam etzadroxil following a 10-hour fast on 3 occasions in a fixed sequence: (a) Ceftibuten and ledaborbactam etzadroxil as separate capsules; (b) Ceftibuten-ledaborbactam etzadroxil as fixed-dose combination capsules; (c) Ceftibuten-ledaborbactam etzadroxil as fixed-dose combination capsules after 5 days of esomeprazole orally once daily

Find a Clinic Near You

Who Is Running the Clinical Trial?

Venatorx Pharmaceuticals, Inc.

Lead Sponsor

Trials
15
Recruited
1,200+

Biomedical Advanced Research and Development Authority

Collaborator

Trials
108
Recruited
574,000+

Published Research Related to This Trial

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]
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 the most effective oral cephalosporin against Enterobacteriaceae that produce plasmid-encoded broad spectrum beta-lactamases, outperforming several other antibiotics.
In a pharmacodynamic model, ceftibuten demonstrated bactericidal activity against Haemophilus influenzae and Streptococcus pneumoniae at concentrations similar to those achieved in human serum after a 200 mg oral dose taken twice daily.
Ceftibuten and bactericidal kinetics. Comparative in vitro activity against Enterobacteriaceae producing extended spectrum beta-lactamases.Bauernfeind, A.[2019]

Citations

Ceftibuten-Ledaborbactam Activity against Multidrug-Resistant and Extended-Spectrum-β-Lactamase-Positive Clinical Isolates of Enterobacterales from a 2018-2020 Global Surveillance Collection. [2022]
In vivo pharmacokinetics and pharmacodynamics of ceftibuten/ledaborbactam, a novel oral β-lactam/β-lactamase inhibitor combination. [2023]
Ceftibuten and bactericidal kinetics. Comparative in vitro activity against Enterobacteriaceae producing extended spectrum beta-lactamases. [2019]
Ceftibuten: a new expanded-spectrum oral cephalosporin. [2019]
Ceftibuten: minimal inhibitory concentrations, postantibiotic effect and beta-lactamase stability--a rationale for dosing programs. [2018]
Ceftibuten: an overview. [2018]
Ceftibuten versus cefaclor for the treatment of bronchitis. [2019]
Ceftibuten. A review of its antibacterial activity, pharmacokinetic properties and clinical efficacy. [2018]
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