Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function

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Description

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

Study Overview

Start Date
January 30, 2023
Completion Date
March 29, 2024
Enrollment
40
Date Posted
February 13, 2023
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
Atea Study Site Orlando Clinical Research Center
Orlando, Florida 32809, United States

Eligibility

Minimum Age (years)
18
Maximum Age (years)
80
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

Study Contact Info

Study Contact Name
Atea Study Clinical Trials Administrator
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
NCTid (if applicable)
NCT05724693