Study of Bemnifosbuvir on Cardiac Repolarization in Healthy Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer Study
• Intervention / Treatment: Drug: Bemnifosbuvir (BEM); Drug: Placebo; Drug: Moxifloxacin

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Montreal, Quebec
    • Québec, Montreal, Quebec, Canada
      • Atea Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placebo-corrected (Δ) change-from-baseline QTc (ΔΔQTc).	C-QTc analysis	24 hours prior to dosing thru 48 hours post dose

Collaborators and Investigators

• Sponsor: Atea Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: AT-03A-008

Drug and device information, study documents

• 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