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

NCT ID: NCT05137626

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-03

Study Completion Date

2021-12-12

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers Study

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AT-527 + digoxin (simultaneous)

n=14

Group Type EXPERIMENTAL

AT-527 + digoxin

Intervention Type 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.

AT-527 + digoxin (staggered)

n=14

Group Type EXPERIMENTAL

AT-527 + digoxin

Intervention Type DRUG

* 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).

Interventions

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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.

Intervention Type 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).

Intervention Type DRUG

Other Intervention Names

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AT-527 is also know as R07496998 AT-527 is also know as R07496998

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atea Study Site

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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AT-03A-013

Identifier Type: -

Identifier Source: org_study_id