Healthy Volunteer, Hepatic Impairment
Conditions
Brief summary
To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose
Interventions
Day 1: A single dose of BEM will be administered
Sponsors
Atea Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 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 * BMI of 18.5 to 42.0 kg/m2 * Willing to comply with the study requirements and to provide written informed consent 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 of subjects 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 of an Investigator * When applicable, presence of mild hepatic impairment (Child-Pugh Class A: score of 5 to 6), moderate hepatic impairment (Child-Pugh Class B: score of 7 to 9) or severe hepatic impairment (Child-Pugh Class C: score of 10 to 15). Hepatic impairment should be stable for at least 1 month prior to Screening
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax) | Day 1 |
| Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC) | Day 1 |
| Pharmacokinetics (PK) of BEM AUC | Day 1 |
Countries
United States
Outcome results
None listed