Drug-drug Interaction Study of Digoxin and AT-527 (R07496998)

A Phase 1, Open-Label Study to Evaluate the Effect of AT-527 on the Pharmacokinetics of Digoxin in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05137626

Enrollment

Registered

2021-11-30

Start date

2021-11-03

Completion date

2021-12-12

Last updated

2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers Study

Brief summary

Drug-drug interaction study of Digoxin and AT-527 (R07496998)

Interventions

DRUGAT-527 + digoxin

* Day 1: A single dose of digoxin will be administered. * Day 15: A single dose of AT-527 and digoxin will be co-administered.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug * Females must have a negative pregnancy test at Screening and prior to dosing * Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2 * Willing to comply with the study requirements and to provide written informed consent

Exclusion criteria

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2 * Abuse of alcohol or drugs * Use of other investigational drugs within 28 days of dosing * Concomitant use of prescription medications, or systemic over-the-counter medications * Other clinically significant medical conditions or laboratory abnormalities

Design outcomes

Primary

Measure	Time frame	Description
To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin	Day 1, Day 15	Maximum plasma concentration (Cmax)
To determine the effect of a staggered dose of AT-527 administered 2 hours before digoxin on the PK of digoxin	Day 1, Day 15	Maximum plasma concentration (Cmax)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026