Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724693
• Other study ID #: AT-03A-010
• Status: Recruiting
• Phase: Phase 1
• Start date: January 30, 2023
• Est. completion date: March 29, 2024

Study information

• Verified date: February 2024
• Source: Atea Pharmaceuticals, Inc.
• Contact: Atea Study Clinical Trials Administrator
• Phone: 888-481-1607
• Email: AteaClinicalTrials[@]ateapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 29, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer
• Hepatic Impairment

Intervention

Drug:
• Bemnifosbuvir (BEM)
Day 1: A single dose of BEM will be administered

Locations

Country	Name	City	State
United States	Atea Study Site Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)		Day 1
Primary	Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)		Day 1
Primary	Pharmacokinetics (PK) of BEM AUC		Day 1