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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05905484
Other study ID # AT-03A-008
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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