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CompletedNCT05137626Updated Feb 28, 2022

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

A Phase 1 interventional study of AT-527 + digoxin and AT-527 + digoxin in Healthy Volunteers Study, sponsored by Atea Pharmaceuticals, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-28.

Sponsored by Atea Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2021, 4 years 9 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
29
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Volunteers Study
03

In context

Lead sponsor

Atea Pharmaceuticals, Inc. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 4 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    AT-527 + digoxin (simultaneous)

    n=14

    Drug: AT-527 + digoxin

  • Experimental
    AT-527 + digoxin (staggered)

    n=14

    Drug: AT-527 + digoxin

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.

    Also known as: AT-527 is also know as R07496998

  • DrugAT-527 + digoxin

    * Day 1: A single dose of digoxin will be administered. * Day 15: A single staggered dose of AT-527 and digoxin will be administered (2 hours later).

    Also known as: AT-527 is also know as R07496998

06

What researchers measure

Primary outcomes

  1. To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin

    Maximum plasma concentration (Cmax)

    Time frame: Day 1, Day 15

  2. To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin

    Area under the concentration-time curve (AUC)

    Time frame: Day 1, Day 15

  3. To determine the effect of a staggered dose of AT-527 administered 2 hours before digoxin on the PK of digoxin

    Maximum plasma concentration (Cmax)

    Time frame: Day 1, Day 15

  4. To determine the effect of a staggered dose of AT-527 administered 2 hours before digoxin on the PK of digoxin

    Area under the concentration-time curve (AUC)

    Time frame: Day 1, Day 15

07

Study locations

1 site
  • Atea Study Site
    Montreal, Quebec, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05137626
Lead sponsor
Atea Pharmaceuticals, Inc.
Collaborators
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Nov 30, 2021
Start date
Nov 3, 2021
Primary completion
Dec 12, 2021
Completion
Dec 12, 2021
Last update
Feb 28, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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