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Completed

NCT Number: NCT05137626

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

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

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Key information

Conditions

Healthy Volunteers Study

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AT-527 + digoxin

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

Other names: AT-527 is also know as R07496998

Primary outcomes

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

    Time frame: Day 1, Day 15

    Maximum plasma concentration (Cmax)

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

    Time frame: Day 1, Day 15

    Area under the concentration-time curve (AUC)

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

    Time frame: Day 1, Day 15

    Maximum plasma concentration (Cmax)

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

    Time frame: Day 1, Day 15

    Area under the concentration-time curve (AUC)

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 30, 2021
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.