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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

Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 10 Jun 2025

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At a glance

  • Drugs Ceftibuten (Primary) ; Ceftibuten/ledaborbactam etzadroxil (Primary) ; Esomeprazole (Primary) ; Ledaborbactam etzadroxil (Primary)
  • Indications Bacterial infections; Urinary tract infections
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors VenatoRx Pharmaceuticals

Most Recent Events

  • 24 Mar 2025 Planned End Date changed from 10 May 2025 to 15 Sep 2025.
  • 24 Mar 2025 Planned primary completion date changed from 7 Mar 2025 to 13 Aug 2025.
  • 07 Feb 2025 Status changed from recruiting to active, no longer recruiting.

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