Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function

NCT05724693 | Completed Phase 1 FDA Drug

• 1 other identifier: AT-03A-010
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer; Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (5)

Group 1 -Mild Hepatic Impairment

EXPERIMENTAL

Drug: single dose Bemnifosbuvir (BEM)

Drug: Bemnifosbuvir (BEM)

Group 2-Moderate Hepatic Impairment

EXPERIMENTAL

Drug: single dose Bemnifosbuvir (BEM)

Drug: Bemnifosbuvir (BEM)

Group 3 - Healthy Subjects matching mild and moderate impairment groups

EXPERIMENTAL

Drug: single dose Bemnifosbuvir (BEM)

Drug: Bemnifosbuvir (BEM)

Group 4 - Severe Hepatic Impairment

EXPERIMENTAL

Drug: single dose Bemnifosbuvir (BEM)

Drug: Bemnifosbuvir (BEM)

Group 5 - Normal hepatic function matching severe impairment group

EXPERIMENTAL

Drug: single dose Bemnifosbuvir (BEM)

Drug: Bemnifosbuvir (BEM)

Interventions

Bemnifosbuvir (BEM) DRUG

Day 1: A single dose of BEM will be administered

Also known as: AT-527

Group 1 -Mild Hepatic Impairment; Group 2-Moderate Hepatic Impairment; Group 3 - Healthy Subjects matching mild and moderate impairment groups; Group 4 - Severe Hepatic Impairment; Group 5 - Normal hepatic function matching severe impairment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atea Pharmaceuticals, Inc.: lead

Study Sites (1)

Atea Study Site Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Interventions

AT-511

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 13, 2023
• Study Start: January 30, 2023
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

US (1)