Faecal pharmacokinetics, microbiome, and bile acid changes in healthy subjects given intravenous followed by oral omadacycline; a Phase 1 clinical trial.

ABSTRACT:

Background

There is an urgent need to develop new antimicrobials effective intravenously for Clostridioides difficile infection (CDI). Omadacycline is an aminomethylcycline tetracycline available orally and intravenously with potent in vitro activity against C. difficile and a low propensity to cause CDI. The purpose of this study was to assess the safety, faecal pharmacokinetics, microbiome and bile acid changes in healthy subjects given a course of intravenous omadacycline with oral omadacycline step down after 5 days.

Methods

This Phase 1, open-label study was conducted in healthy volunteers 18-40 years. Subjects received a 5-day course of omadacycline given intravenously followed by 5 days of oral omadacycline. Stool samples were analysed for omadacycline concentrations,

SUBMITTER: Jo J 

PROVIDER: S-EPMC12494138 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature