Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function

NCT ID: NCT05724693

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2024-04-23

Brief Summary

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

Conditions

Healthy Volunteer; Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 -Mild Hepatic Impairment

Drug: single dose Bemnifosbuvir (BEM)

Group Type: EXPERIMENTAL

Bemnifosbuvir (BEM)

Intervention Type: DRUG

Day 1: A single dose of BEM will be administered

Group 2-Moderate Hepatic Impairment

Drug: single dose Bemnifosbuvir (BEM)

Group Type: EXPERIMENTAL

Bemnifosbuvir (BEM)

Intervention Type: DRUG

Day 1: A single dose of BEM will be administered

Group 3 - Healthy Subjects matching mild and moderate impairment groups

Drug: single dose Bemnifosbuvir (BEM)

Group Type: EXPERIMENTAL

Bemnifosbuvir (BEM)

Intervention Type: DRUG

Day 1: A single dose of BEM will be administered

Group 4 - Severe Hepatic Impairment

Drug: single dose Bemnifosbuvir (BEM)

Group Type: EXPERIMENTAL

Bemnifosbuvir (BEM)

Intervention Type: DRUG

Day 1: A single dose of BEM will be administered

Group 5 - Normal hepatic function matching severe impairment group

Drug: single dose Bemnifosbuvir (BEM)

Group Type: EXPERIMENTAL

Bemnifosbuvir (BEM)

Intervention Type: DRUG

Day 1: A single dose of BEM will be administered

Interventions

Bemnifosbuvir (BEM)

Day 1: A single dose of BEM will be administered

Intervention Type: DRUG

Other Intervention Names

AT-527

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Atea Study Site Orlando Clinical Research Center

Orlando, Florida, United States

Countries

United States

Other Identifiers

AT-03A-010

Identifier Type: -

Identifier Source: org_study_id