Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function

Launched by ATEA PHARMACEUTICALS, INC. · Mar 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination medication called Bemnifosbuvir/Ruzasvir to see how well it is processed in the body of people with severe liver (hepatic) or kidney (renal) impairment compared to those with normal liver and kidney function. The trial aims to understand how these conditions affect the way the medication works after a single dose. It's an early-phase study, and it hasn’t started recruiting participants yet.

To be eligible for the trial, participants must be between 18 and 75 years old and agree to use two forms of birth control if they are capable of becoming pregnant. People with severe liver or kidney issues need to be stable in their condition, while those with normal function should be healthy and matched by age and body size to the other groups. Participants can expect to take the medication and undergo monitoring to help researchers gather important information. It's also important to know that individuals with certain health issues, like active infections or significant diabetes, won't be able to participate in this study.

Gender

ALL

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 43.0 kg/m2
• • Willing to comply with the study requirements and to provide written informed consent
• Renal Impaired Subjects (Group 1):
• • Considered stable in the judgement of an Investigator
• • Presence of severe renal impairment or kidney failure (as defined by eGFR\< 30 mL/ min)
• Hepatic Impaired Subjects (Group 2):
• • Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator
• • Presence of severe hepatic impairment (Child-Pugh Class C: score of 10 to 15).
• Subjects with Normal Hepatic and Renal Function (Group 3):
• • Medically healthy, in the opinion of an Investigator
• • Must match by gender, age (± 10 years), and BMI (within 20%) to the pooled mean values of subjects with severe renal and hepatic impairment
• Exclusion Criteria:
• • Pregnant or breastfeeding
• • Infected with hepatitis B virus, hepatitis C virus or HIV
• • Abuse of alcohol or drugs
• • Use of other investigational drugs within 28 days of dosing
• • Other clinically significant medical conditions or laboratory abnormalities
• Renal and Hepatic Impaired Subjects (Group 1 and 2):
• • Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c \> 10%
• • Undergoing any method of dialysis
• • Subjects requiring treatment for hepatic impairment or other chronic disease must be on a stable treatment plan
• Renal Impaired Subjects (Group 1):
• • History of renal transplant
• • Concurrent use of medications known to affect the elimination of serum creatinine
• Hepatic Impaired Subjects (Group 2):
• • History of liver transplant
• • Evidence of hepatic carcinoma presence at Screening