Healthy Volunteer Study
Conditions
Brief summary
This study will assess the safety, tolerability and pharmacokinetics (PK) of Bemnifosbuvir in healthy adult Japanese subjects
Interventions
BEM administered BID for 4 days and QD on Day 5 (9 consecutive doses)
Sponsors
Atea Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 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 18-32 kg/m2 * Willing to comply with the study requirements and to provide written informed consent * The subject must have been born in Japan and have both parents and 4 grandparents of Japanese descent * The subject must have lived outside of Japan for no more than 10 years
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 |
|---|---|
| Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax) | Day 1, Day 5 |
| Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC) | Day 1, Day 5 |
Countries
United States
Outcome results
None listed