CClinicalTrials.gg
Sign In
CompletedNCT05905484Updated Jun 15, 2023

Study of Bemnifosbuvir on Cardiac Repolarization in Healthy Subjects

A Phase 1 interventional study of Bemnifosbuvir (BEM) and Placebo in Healthy Volunteer Study, sponsored by Atea Pharmaceuticals, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by Atea Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2023, 3 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Volunteer Study
03

In context

Lead sponsor

Atea Pharmaceuticals, Inc. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 4 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Bemnifosbuvir (BEM) therapeutic dose

    oral tablets

    Drug: Bemnifosbuvir (BEM)

  • Experimental
    Bemnifosbuvir (BEM) supratherapeutic dose

    oral tablets

    Drug: Bemnifosbuvir (BEM)

  • Placebo comparator
    Placebo

    oral tablets

    Drug: Placebo

  • Active comparator
    Moxifloxacin

    oral tablet

    Drug: Moxifloxacin

Interventions

  • DrugBemnifosbuvir (BEM)

    A single dose of BEM will be administered.

    Also known as: AT-527

  • DrugPlacebo

    A single dose of matching placebo will be administered.

  • DrugMoxifloxacin

    A single dose of Moxifloxacin will be administered.

06

What researchers measure

Primary outcomes

  1. Placebo-corrected (Δ) change-from-baseline QTc (ΔΔQTc).

    C-QTc analysis

    Time frame: 24 hours prior to dosing thru 48 hours post dose

07

Study locations

1 site
  • Atea Study Site
    Québec, Montreal, Quebec, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05905484
Lead sponsor
Atea Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
Apr 25, 2023
Primary completion
May 31, 2023
Completion
May 31, 2023
Last update
Jun 15, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Atea Pharmaceuticals, Inc.

Start the discussion