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

Phase 1

Completed

• Conditions: Healthy Volunteers Study
• Interventions: Drug: AT-527 + digoxin

• Registration Number: NCT05137626
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-28
• Study Start: 2021-11-03
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-30
• Primary Completion: 2021-12-12
• Study Completion: 2021-12-12
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AT-527 + digoxin (staggered)	AT-527 + digoxin	n=14
AT-527 + digoxin (simultaneous)	AT-527 + digoxin	n=14

Primary Outcome Measures

Name	Time	Method
To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin	Day 1, Day 15	Area under the concentration-time curve (AUC)
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	Area under the concentration-time curve (AUC)

Trial Locations

Locations (1)

Atea Study Site; 🇨🇦 Montreal, Quebec, Canada