Actively Recruiting
A Phase 1, Open-Label, Single-Dose Study to Evaluate Safety and Drug Processing of Bemnifosbuvir and Ruzasvir in Adults With Severe Renal or Hepatic Impairment Compared to Healthy Subjects
Led by Atea Pharmaceuticals, Inc. · Updated on 2026-04-13
28
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how severe liver or kidney impairment affects the way the body processes a fixed-dose combination of two drugs, Bemnifosbuvir and Ruzasvir. This Phase 1 trial compares people with severe kidney or liver issues to healthy individuals to better understand the drugs' behavior in different conditions. The study is sponsored by Atea Pharmaceuticals, Inc. and focuses on safety and pharmacokinetics after a single dose. Participants receive one dose of the Bemnifosbuvir/Ruzasvir combination. The trial includes three groups: those with severe kidney impairment, those with severe liver impairment, and healthy volunteers matched by age, gender, and body mass index. Each participant will receive a single dose of the study drug, and the study is open-label without placebo or blinding. During the study, researchers will measure drug levels in the blood to determine maximum concentration and overall exposure on the first day after dosing. Participants must comply with birth control requirements and pregnancy testing if applicable. The study includes safety monitoring and assessments to evaluate how the drugs behave in people with different levels of kidney and liver function. The trial is expected to continue until May 2026, with participants involved for a limited period around dosing.
CONDITIONS
Brief 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...
- Adults aged 18 to 80 years
- 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 prior to dosing
- Body mass index (BMI) between 18.5 and 43.0 kg/m2
- Willing to comply with study requirements and provide written informed consent
- Renal impaired subjects must be stable and have severe renal impairment or kidney failure (eGFR < 30 mL/min)
- Hepatic impaired subjects must be stable for at least 1 month prior to screening and have severe hepatic impairment (Child-Pugh Class C: score 10 to 15)
- Subjects with normal liver and kidney function must be medically healthy and match age, gender, and BMI of 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 of dosing
- Other clinically significant medical conditions or lab abnormalities
- For renal and hepatic impaired subjects: poorly controlled diabetes (Hemoglobin A1c > 10%)
- Undergoing any form of dialysis
- Renal impaired subjects with history of renal transplant or using medications affecting creatinine elimination
- Hepatic impaired subjects with history of liver transplant or evidence of liver cancer at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single dose of Bemnifosbuvir/Ruzasvir as a fixed-dose combination.
1 treatment visit (in-person)
Duration - Up to 90 days after dosing
Participants are monitored for safety and drug processing after dosing.
Multiple follow-up visits for up to 90 days
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
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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