The Study of Bemnifosbuvir in Healthy Japanese Subjects
Phase 1
Completed
- Conditions
- Healthy Volunteer Study
- Interventions
- Drug: Bemnifosbuvir (BEM)
- Registration Number
- NCT05905497
- Lead Sponsor
- Atea Pharmaceuticals, Inc.
- Brief Summary
This study will assess the safety, tolerability and pharmacokinetics (PK) of Bemnifosbuvir in healthy adult Japanese subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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
Read More
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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bemnifosbuvir (BEM) Bemnifosbuvir (BEM) oral tablet
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Atea Study Site
🇺🇸Cypress, California, United States