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Recruiting NCT06733675

Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination

Phase I Interventional Healthy Volunteer Pharmacokinetics Safety Drug-Drug Interaction (DDI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ledaborbactam etzadroxil, Ceftibuten, Ceftibuten-ledaborbactam etzadroxil, Esomeprazole.
Who it may be relevant to
Registry conditions: Healthy Volunteer, Pharmacokinetics, Safety, Drug-Drug Interaction (DDI). Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase 1, Open-label Study to Evaluate the Safety and to Characterize the Pharmacokinetics of a Fixed-Dose Combination Formulation of Ceftibuten-Ledaborbactam Etzadroxil

Overview

This is a Phase 1, open-label, three-part, study in approximately 96 healthy adult participants between 18 and 55 years of age (both inclusive) (16 participants in Part 1, 20 participants in Part 2 and , and approximately 60 participants in Part 3). 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 , 43 days for Part 2 and 83 days for Part 3. All participants in Parts I und 2 will be screened within 28 days prior to dosing. All participants in Part 3 will be screened within 33 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. Participants in Part 3 will also return to the clinic for follow-up assessments 28 days ± 2 days and 42 days ± 2 days after the last dose of study intervention.

Interventions

  • Drug Ledaborbactam etzadroxil
    capsules
  • Drug Ceftibuten
    capsules
  • Drug Ceftibuten-ledaborbactam etzadroxil
    Fixed Dose Combination (FDC)
  • Drug Esomeprazole
    40 mg capsule
  • Drug amoxicillin-clavulanate
    500 mg-125 mg oral doses

Primary outcome measures

  • Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil) [Time frame: 0 - 48 hours on days 1, 4 and 11]
  • Part 1 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil) [Time frame: 0 - 48 hours on days 1, 4 and 11]
  • Proportion of participants of Part 2 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation. [Time frame: Day 1 thru Day 18 (+/-1)]
  • Proportion of participants of Part 3 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation. [Time frame: Day 1 thru Day 49 (± 2 days)]
Secondary outcome measures (5)
  • Proportion of participants of Part 1 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation. [Time frame: Day 1 thru Day 18 (+/-1)]
  • Part 2 Plasma PK AUC0-12h (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil) [Time frame: Day 1 and Day 7]
  • Part 2 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil) [Time frame: Day 1 and Day 7]
  • Part 3 Plasma PK AUC0-Tau (ceftibuten and/or ledaborbactam) [Time frame: At Day 1 and Day 7]
  • Part 3 Plasma PK Cmax (ceftibuten and/or ledaborbactam) [Time frame: At Day 1 and Day 7]

Eligibility criteria

Inclusion criteria

  • Healthy adult male or female, between 18 and 55 years of age
  • Body mass index ≥ 18 and ≤ 32 kg/m2
  • Laboratory values meeting defined laboratory ranges
  • Males or non-pregnant, non-lactating females

Exclusion criteria

  • History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug
  • Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant
  • Positive alcohol, drug or tobacco use/test

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • ICON, Clinical Research Phase I Unit — Lenexa

Identifiers

NCT: NCT06733675 · VNRX-7145-106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗