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

Sponsor
Atea Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05137626
Collaborator
Hoffmann-La Roche (Industry)
29
Enrollment
1
Location
2
Arms
1.3
Actual Duration (Months)
22.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: AT-527 + digoxin
  • Drug: AT-527 + digoxin
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-Label Study to Evaluate the Effect of AT-527 on the Pharmacokinetics of Digoxin in Healthy Adult Subjects
Actual Study Start Date :
Nov 3, 2021
Actual Primary Completion Date :
Dec 12, 2021
Actual Study Completion Date :
Dec 12, 2021

Arms and Interventions

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

    		•
    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 staggered dose of AT-527 and digoxin will be administered (2 hours later).
    Other Names:
  • AT-527 is also know as R07496998

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To determine the effect of AT-527 on the single-dose pharmacokinetics (PK) of digoxin [Day 1, Day 15]

      Maximum plasma concentration (Cmax)

    2. 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)

    3. 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]

      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 [Day 1, Day 15]

      Area under the concentration-time curve (AUC)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Atea Study Site Montreal Quebec Canada

    Sponsors and Collaborators

    • Atea Pharmaceuticals, Inc.
    • Hoffmann-La Roche

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Atea Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT05137626
    Other Study ID Numbers:
    • AT-03A-013
    First Posted:
    Nov 30, 2021
    Last Update Posted:
    Feb 28, 2022
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Digoxin

    Study Results

    No Results Posted as of Feb 28, 2022