Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Healthy Volunteer

Treatments: Drug: Bemnifosbuvir (BEM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05724693

AT-03A-010

Details and patient eligibility

About

To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose

Enrollment: 39 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 5 patient groups

Group 1 -Mild Hepatic Impairment

Experimental group

Description:

Drug: single dose Bemnifosbuvir (BEM)

Treatment:

Drug: Bemnifosbuvir (BEM)

Group 2-Moderate Hepatic Impairment

Experimental group

Description:

Drug: single dose Bemnifosbuvir (BEM)

Treatment:

Drug: Bemnifosbuvir (BEM)

Group 3 - Healthy Subjects matching mild and moderate impairment groups

Experimental group

Description:

Drug: single dose Bemnifosbuvir (BEM)

Treatment:

Drug: Bemnifosbuvir (BEM)

Group 4 - Severe Hepatic Impairment

Experimental group

Description:

Drug: single dose Bemnifosbuvir (BEM)

Treatment:

Drug: Bemnifosbuvir (BEM)

Group 5 - Normal hepatic function matching severe impairment group

Experimental group

Description:

Drug: single dose Bemnifosbuvir (BEM)

Treatment:

Drug: Bemnifosbuvir (BEM)