Phase
Condition
N/ATreatment
Bemnifosbuvir (BEM)
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must agree to use two methods of birth control from Screening through 90 days afteradministration of the last dose of study drug
Females must have a negative pregnancy test at Screening and prior to dosing
BMI of 18.5 to 42.0 kg/m2
Willing to comply with the study requirements and to provide written informedconsent
Subjects with Normal Hepatic Function (Groups 3 and 5):
Medically healthy, in the opinion of an Investigator
Must match by gender, age (± 10 years), and BMI (± 20%) to the pooled mean values ofsubjects with hepatic impairment
Hepatic Impaired Subjects (Groups 1, 2, and 4):
Considered stable for at least 1 month prior to Screening, as per the judgement ofan Investigator
When applicable, presence of mild hepatic impairment (Child-Pugh Class A: score of 5to 6), moderate hepatic impairment (Child-Pugh Class B: score of 7 to 9) or severehepatic impairment (Child-Pugh Class C: score of 10 to 15). Hepatic impairmentshould be stable for at least 1 month prior to Screening
Exclusion
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
Hepatic Impaired Subjects (Groups 1, 2, and 4):
Currently undergoing any method of dialysis
History of liver transplant
Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c (HbA1c) > 10%
Evidence of hepatic carcinoma presence at Screening
Study Design
Connect with a study center
Atea Study Site Orlando Clinical Research Center
Orlando, Florida 32809
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.