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: 13 Oct 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

29 Sep 2025 Planned End Date changed from 15 Sep 2025 to 30 Jun 2026.
29 Sep 2025 Planned primary completion date changed from 13 Aug 2025 to 30 Jun 2026.
24 Mar 2025 Planned End Date changed from 10 May 2025 to 15 Sep 2025.

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