Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function

Study Overview
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Brief Summary
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To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose

Official Title
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A Phase 1, Multicenter, Open-Label, Parallel-Group, Pharmacokinetic Single Dose Study of Bemnifosbuvir (AT-527) in Adult Subjects With Normal and Impaired Hepatic Function

Conditions
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Healthy Volunteer, Hepatic Impairment

Intervention / Treatment
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* Drug: Bemnifosbuvir (BEM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 -Mild Hepatic Impairment<br>Drug: single dose Bemnifosbuvir (BEM) | Drug: Bemnifosbuvir (BEM)<br>* Day 1: A single dose of BEM will be administered<br>* Other names: AT-527;|
| Experimental: Group 2-Moderate Hepatic Impairment<br>Drug: single dose Bemnifosbuvir (BEM) | Drug: Bemnifosbuvir (BEM)<br>* Day 1: A single dose of BEM will be administered<br>* Other names: AT-527;|
| Experimental: Group 3 - Healthy Subjects matching mild and moderate impairment groups<br>Drug: single dose Bemnifosbuvir (BEM) | Drug: Bemnifosbuvir (BEM)<br>* Day 1: A single dose of BEM will be administered<br>* Other names: AT-527;|
| Experimental: Group 4 - Severe Hepatic Impairment<br>Drug: single dose Bemnifosbuvir (BEM) | Drug: Bemnifosbuvir (BEM)<br>* Day 1: A single dose of BEM will be administered<br>* Other names: AT-527;|
| Experimental: Group 5 - Normal hepatic function matching severe impairment group<br>Drug: single dose Bemnifosbuvir (BEM) | Drug: Bemnifosbuvir (BEM)<br>* Day 1: A single dose of BEM will be administered<br>* Other names: AT-527;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |