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Study of Bemnifosbuvir on Cardiac Repolarization in Healthy Subjects

Sponsor
Atea Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05905484
Collaborator
(none)
35
Enrollment
1
Location
4
Arms
1.2
Actual Duration (Months)
29.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the effects of Bemnifosbuvir on cardiac repolarization in healthy Adult Subjects

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Double-blind, Single-dose, Randomized, Placebo and Active-Controlled, Four-Way Crossover Study Evaluating the Effects of Bemnifosbuvir on Cardiac Repolarization in Healthy Adult Subjects
Actual Study Start Date :
Apr 25, 2023
Actual Primary Completion Date :
May 31, 2023
Actual Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bemnifosbuvir (BEM) therapeutic dose

oral tablets

Drug: Bemnifosbuvir (BEM)
A single dose of BEM will be administered.
Other Names:
  • AT-527

    		•
    Experimental: Bemnifosbuvir (BEM) supratherapeutic dose

    oral tablets

    Drug: Bemnifosbuvir (BEM)
    A single dose of BEM will be administered.
    Other Names:
  • AT-527

    		•
    Placebo Comparator: Placebo

    oral tablets

    Drug: Placebo
    A single dose of matching placebo will be administered.
    Active Comparator: Moxifloxacin

    oral tablet

    Drug: Moxifloxacin
    A single dose of Moxifloxacin will be administered.

    Outcome Measures

    Primary Outcome Measures

    1. Placebo-corrected (Δ) change-from-baseline QTc (ΔΔQTc). [24 hours prior to dosing thru 48 hours post dose]

      C-QTc analysis

    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 18-29 kg/m2

    • Willing to comply with the study requirements and to provide written informed consent

    Exclusion Criteria:

    • Pregnant or breastfeeding

    • Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19

    • Abuse of alcohol or drugs

    • Use of other investigational drugs within 28 days of dosing

    • Other clinically significant medical conditions or laboratory abnormalities

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Atea Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Atea Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT05905484
    Other Study ID Numbers:
    • AT-03A-008
    First Posted:
    Jun 15, 2023
    Last Update Posted:
    Jun 15, 2023
    Last Verified:
    May 1, 2023
    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:
    Moxifloxacin

    Study Results

    No Results Posted as of Jun 15, 2023