Healthy Volunteer Study
Conditions
Brief summary
This study will assess the effects of Bemnifosbuvir on cardiac repolarization in healthy Adult Subjects
Interventions
A single dose of BEM will be administered.
DRUGPlacebo
A single dose of matching placebo will be administered.
DRUGMoxifloxacin
A single dose of Moxifloxacin will be administered.
Sponsors
Atea Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Placebo-corrected (Δ) change-from-baseline QTc (ΔΔQTc). | 24 hours prior to dosing thru 48 hours post dose | C-QTc analysis |
Countries
Canada
Outcome results
None listed