RecruitingPhase 1NCT06911320

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

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of Bemnifosbuvir and Ruzasvir Administered as a Fixed-Dose Combination in Adult Participants With Severe Renal or Hepatic Impairment in Comparison to Healthy Participants

Sponsor

Atea Pharmaceuticals, Inc.

Enrollment

28 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteer Study Renal Impairment Hepatic Impairment

Summary

To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria13

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 Criteria15

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