Study of Bemnifosbuvir on Cardiac Repolarization in Healthy Subjects

Healthy Volunteer Study Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05905484
• Other study ID #: AT-03A-008
• Status: Completed
• Phase: Phase 1
• Start date: April 25, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: May 2023
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• Bemnifosbuvir (BEM)
A single dose of BEM will be administered.
• Placebo
A single dose of matching placebo will be administered.
• Moxifloxacin
A single dose of Moxifloxacin will be administered.

Locations

Country	Name	City	State
Canada	Atea Study Site	Québec	Montreal, Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placebo-corrected (?) change-from-baseline QTc (??QTc).	C-QTc analysis	24 hours prior to dosing thru 48 hours post dose