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

NCT05137548 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-02-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Antios Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2021-12-23
Completion
2021-12-23

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05137548 on ClinicalTrials.gov