The Study of Bemnifosbuvir in Healthy Japanese Subjects

Healthy Volunteer Study Clinical Trial

Official title:

A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Bemnifosbuvir in Healthy Adult Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05905497
• Other study ID #: AT-03A-018
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2023
• Est. completion date: May 19, 2023

Study information

• Verified date: June 2023
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety, tolerability and pharmacokinetics (PK) of Bemnifosbuvir in healthy adult Japanese subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 19, 2023
• Est. primary completion date: May 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 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 18-32 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

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• Bemnifosbuvir (BEM)
BEM administered BID for 4 days and QD on Day 5 (9 consecutive doses)

Locations

Country	Name	City	State
United States	Atea Study Site	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)		Day 1, Day 5
Primary	Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)		Day 1, Day 5