Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function

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

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

Study Overview

• Status: Recruiting
• Conditions: Hepatic Impairment; Healthy Volunteer
• Intervention / Treatment: Drug: Bemnifosbuvir (BEM)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Atea Study Clinical Trials Administrator; Phone Number: 888-481-1607; Email: ateaclinicaltrials@ateapharma.com

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Recruiting
      • Atea Study Site Orlando Clinical Research Center
      • Contact: Atea Study Site (OCRC); Phone Number: 888-481-1607; Email: AteaClinicalTrials@ateapharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Atea Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): March 29, 2024
• Study Completion (Estimated): March 29, 2024

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AT-03A-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No