NCT05905484

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
Last Updated

June 15, 2023

Status Verified

May 1, 2023

Enrollment Period

1 month

First QC Date

April 20, 2023

Last Update Submit

June 14, 2023

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (1)

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

    C-QTc analysis

    24 hours prior to dosing thru 48 hours post dose

Study Arms (4)

Bemnifosbuvir (BEM) therapeutic dose

EXPERIMENTAL

oral tablets

Drug: Bemnifosbuvir (BEM)

Bemnifosbuvir (BEM) supratherapeutic dose

EXPERIMENTAL

oral tablets

Drug: Bemnifosbuvir (BEM)

Placebo

PLACEBO COMPARATOR

oral tablets

Drug: Placebo

Moxifloxacin

ACTIVE COMPARATOR

oral tablet

Drug: Moxifloxacin

Interventions

Bemnifosbuvir (BEM)DRUG

A single dose of BEM will be administered.

Also known as: AT-527
Bemnifosbuvir (BEM) supratherapeutic doseBemnifosbuvir (BEM) therapeutic dose
PlaceboDRUG

A single dose of matching placebo will be administered.

Placebo
MoxifloxacinDRUG

A single dose of Moxifloxacin will be administered.

Moxifloxacin

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atea Study Site

Québec, Montreal, Quebec, Canada

Location

MeSH Terms

Interventions

AT-511Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2023

First Posted

June 15, 2023

Study Start

April 25, 2023

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

June 15, 2023

Record last verified: 2023-05

Locations

CA(1)