Actively Recruiting
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
Led by Atea Pharmaceuticals, Inc. · Updated on 2026-04-13
28
Participants Needed
2
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
CONDITIONS
Official Title
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to use two methods of birth control from screening through 90 days after last dose
- Females must have a negative pregnancy test at screening and before dosing
- Body Mass Index between 18.5 and 43.0 kg/m2
- Willing to follow study requirements and provide written consent
- Renal impaired subjects must be stable and have severe kidney impairment (eGFR < 30 mL/min)
- Hepatic impaired subjects must be stable for at least 1 month and have severe liver impairment (Child-Pugh Class C, score 10-15)
- Healthy subjects must be medically healthy and matched by gender, age (±10 years), and BMI (within 20%) to impaired groups
You will not qualify if you...
- 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 before dosing
- Other significant medical conditions or lab abnormalities
- Poorly controlled diabetes (Hemoglobin A1c > 10%) in renal or hepatic impaired subjects
- Undergoing dialysis
- Renal or hepatic impaired subjects must be on stable treatment plans
- History of renal transplant (renal impaired subjects)
- Use of medications affecting serum creatinine elimination (renal impaired subjects)
- History of liver transplant (hepatic impaired subjects)
- Evidence of liver cancer at screening (hepatic impaired subjects)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Atea Study Site
Orlando, Florida, United States, 32809
Actively Recruiting
2
Atea Study Site
Tampa, Florida, United States, 33603
Actively Recruiting
Research Team
A
Atea Study Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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