Status:
RECRUITING
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
Lead Sponsor:
Atea Pharmaceuticals, Inc.
Conditions:
Healthy Volunteer Study
Hepatic Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06911320
Start Date
April 9 2025
End Date
November 1 2025
Last Update
September 30 2025
Active Locations (2)
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1
Atea Study Site
Orlando, Florida, United States, 32809
2
Atea Study Site
Tampa, Florida, United States, 33603