NCT06911320 · Atea Pharmaceuticals, Inc.
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
What this study is about
To Assess the Effect of Severe Hepatic or Renal Impairment on the how the drug moves through the body of Bemnifosbuvir/Ruzasvir After a Single Dose
View original scientific description
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
Interventions
DRUG
Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
A single dose of BEM/RZR will be administered
Primary outcome measures
Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax)
Time frame: Day 1
Pharmacokinetics (PK) of BEM/RZR Area under the plasma concentration-time curve (AUC)
Time frame: Day 1
Pharmacokinetics (PK) of BEM/RZR AUC
Time frame: Day 1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Orlando, Florida
- Tampa, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations