The Study of Bemnifosbuvir in Healthy Japanese Subjects
A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Bemnifosbuvir in Healthy Adult Japanese Subjects
1 other identifier
interventional
14
1 country
1
Brief Summary
This study will assess the safety, tolerability and pharmacokinetics (PK) of Bemnifosbuvir in healthy adult Japanese subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2023
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2023
CompletedStudy Start
First participant enrolled
April 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedJune 15, 2023
June 1, 2023
23 days
April 20, 2023
June 14, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Bemnifosbuvir (BEM)
EXPERIMENTALoral tablet
Interventions
BEM administered BID for 4 days and QD on Day 5 (9 consecutive doses)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atea Study Site
Cypress, California, 90630, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2023
First Posted
June 15, 2023
Study Start
April 26, 2023
Primary Completion
May 19, 2023
Study Completion
May 19, 2023
Last Updated
June 15, 2023
Record last verified: 2023-06