Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function

Phase 1

Completed

• Conditions: Healthy Volunteer; Hepatic Impairment
• Interventions: Drug: Bemnifosbuvir (BEM)

• Registration Number: NCT05724693
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-24
• Study Start: 2023-01-30
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-13
• Primary Completion: 2024-04-23
• Study Completion: 2024-04-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 5 - Normal hepatic function matching severe impairment group	Bemnifosbuvir (BEM)	Drug: single dose Bemnifosbuvir (BEM)
Group 4 - Severe Hepatic Impairment	Bemnifosbuvir (BEM)	Drug: single dose Bemnifosbuvir (BEM)
Group 1 -Mild Hepatic Impairment	Bemnifosbuvir (BEM)	Drug: single dose Bemnifosbuvir (BEM)
Group 2-Moderate Hepatic Impairment	Bemnifosbuvir (BEM)	Drug: single dose Bemnifosbuvir (BEM)
Group 3 - Healthy Subjects matching mild and moderate impairment groups	Bemnifosbuvir (BEM)	Drug: single dose Bemnifosbuvir (BEM)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of BEM AUC	Day 1
Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)	Day 1
Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)	Day 1

Trial Locations

Locations (1)

Atea Study Site Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States