NCT05137548

A Drug-Drug Interaction Study Between ATI-2173 and Tenofovir Disoproxil Fumarate in Healthy Subjects

A Phase 1, Open-label, 2-cohort, Multiple Dose, Drug-drug Interaction, Safety and Tolerability, Fixed-sequence Study to Investigate the Potential Interaction Between ATI-2173 When Coadministered With Tenofovir Disoproxil Fumarate in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Antios Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, open-label, 2-cohort, multiple dose, fixed-sequence, DDI study in healthy adult subjects. Healthy volunteers will be administered multiple oral doses of ATI-2173 in combination with tenofovir disoproxil fumarate 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 tenofovir disoproxil fumarate.

Conditions

• Drug Interaction

Interventions

Type	Name	Description
DRUG	ATI-2173 50 mg	ATI-2173 is a liver-targeted phosphoramidate oral 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	Tenofovir 300Mg Oral Tablet	Tenofovir is an oral nucleotide analogue reverse transcriptase inhibitor used for chronic hepatitis B virus. It will be dosed as a tablet by mouth

Timeline

• Start date: 2021-10-27
• Primary completion: 2021-12-23
• Completion: 2021-12-23
• First posted: 2021-11-30
• Last updated: 2022-02-04

Locations

1 site across 1 country: Canada