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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers Study
• Intervention / Treatment: Drug: AT-527 + digoxin; Drug: AT-527 + digoxin

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Atea Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AT-527 + digoxin (simultaneous); n=14	Drug: AT-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.; Other Names: AT-527 is also know as R07496998; Drug: AT-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).; Other Names: AT-527 is also know as R07496998
Experimental: AT-527 + digoxin (staggered); n=14	Drug: AT-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.; Other Names: AT-527 is also know as R07496998; Drug: AT-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).; Other Names: AT-527 is also know as R07496998

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin	Maximum plasma concentration (Cmax)	Day 1, Day 15
To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin	Area under the concentration-time curve (AUC)	Day 1, Day 15
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)	Day 1, Day 15
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)	Day 1, Day 15

Collaborators and Investigators

• Sponsor: Atea Pharmaceuticals, Inc.
• Collaborators: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): December 12, 2021
• Study Completion (Actual): December 12, 2021

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Digoxin
• Other Study ID Numbers: AT-03A-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes