NCT05137600

A Drug-Drug Interaction Study Between ATI-2173 and Midazolam or Clarithromycin in Healthy Subjects

A Phase 1, Open-label, 2-cohort, Fixed-sequence, Drug-drug Interaction Study to Investigate the Potential Interaction Between ATI-2173 When Coadministered With Midazolam or Clarithromycin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Antios Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, open-label, 2-cohort, fixed-sequence, DDI study in healthy adult subjects. Healthy volunteers will be administered multiple oral doses of ATI-2173 in combination with midazolam or clarithromycin and assessed for safety and tolerability including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the investigational drug interacts with midazolam or clarithromycin.

Conditions

• Drug Drug Interaction

Interventions

Type	Name	Description
DRUG	ATI-2173	ATI-2173 is a liver-targeted phosphoramidate prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth
DRUG	Midazolam	Midazolam is a sensitive CYP3A index substrate
DRUG	Clarithromycin	Clarithromycin is a sensitive P-gp index inhibitor to evaluate potential effect of P-gp inhibition on ATI-2173 and its metabolites(clarithromycin)

Timeline

• Start date: 2021-10-28
• Primary completion: 2021-12-23
• Completion: 2022-01-23
• First posted: 2021-11-30
• Last updated: 2022-02-04

Locations

1 site across 1 country: Canada