Bemnifosbuvir/Ruzasvir for Liver Disease and Kidney Failure

Recruiting at 1 trial location

Overseen By Atea Study Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Atea Pharmaceuticals, Inc.

Must not be taking: Investigational drugs, Creatinine drugs

Disqualifiers: Pregnancy, Hepatitis, HIV, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Single dose

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how individuals with impaired liver or kidney function process a new treatment called Bemnifosbuvir/Ruzasvir, a combination drug. It includes three groups: individuals with serious liver problems, those with serious kidney issues, and healthy individuals for comparison. The goal is to understand how a single dose of this treatment behaves in people with liver or kidney challenges. Those with stable severe kidney failure or liver problems might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are being treated for liver or kidney issues, you must be on a stable treatment plan.

Is there any evidence suggesting that Bemnifosbuvir/Ruzasvir is likely to be safe for humans?

Research has shown that the combination of bemnifosbuvir and ruzasvir has been tested for safety in healthy individuals. The results indicated that it was generally well-tolerated, with most participants experiencing no serious side effects. In these studies, the treatment's safety profile aligned with expectations for this type of medication.

Bemnifosbuvir has also been used in other studies, which found it to have a low risk of causing interactions with other medicines. This is a positive sign for its safety when used alongside other treatments. Although the current trial is in the early stages, past research provides some confidence in its safety for new participants, including those with severe liver or kidney issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Bemnifosbuvir/Ruzasvir because it offers a new approach to treating liver disease and kidney failure. Unlike current treatments, which often focus on managing symptoms with medications like diuretics or ACE inhibitors, Bemnifosbuvir/Ruzasvir combines two active ingredients that could potentially target the underlying causes of these conditions. This fixed-dose combination might streamline treatment by reducing the pill burden for patients. By using a novel mechanism, it could improve effectiveness and patient outcomes compared to existing therapies.

What evidence suggests that Bemnifosbuvir/Ruzasvir might be an effective treatment for liver disease and kidney failure?

Research has shown that the combination of Bemnifosbuvir and Ruzasvir yields promising results for treating hepatitis C. In a study with 275 patients, this drug combo successfully cleared the virus in 98% of participants after eight weeks. This success rate, known as SVR12, indicates the virus was not detected in the blood 12 weeks after treatment ended. These findings suggest the treatment could be effective, particularly for long-term hepatitis C infections. In this trial, participants with severe renal or hepatic impairment, along with matched healthy subjects, will receive a single dose of the Bemnifosbuvir/Ruzasvir combination to evaluate its effects in these specific populations. Previous data strongly supports its potential effectiveness. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This study is for people with severe liver or kidney problems, as well as healthy individuals. Participants will receive a single dose of a combined medication called Bemnifosbuvir/Ruzasvir to see how their bodies handle the drug.

Inclusion Criteria

Willing to comply with the study requirements and to provide written informed consent

Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug

I have taken a pregnancy test and it was negative.

Exclusion Criteria

Pregnant or breastfeeding

Use of other investigational drugs within 28 days of dosing

Abuse of alcohol or drugs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of Bemnifosbuvir/Ruzasvir as a fixed-dose combination

Single dose

Follow-up

Participants are monitored for safety and pharmacokinetics after the single dose

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bemnifosbuvir/Ruzasvir

Trial Overview The trial is testing how a fixed-dose combination of two drugs, Bemnifosbuvir and Ruzasvir, behaves in the body after one dose in people with normal health or those with severe liver or kidney issues.

How Is the Trial Designed?

Group I: Group 3 - Matched Healthy Subjects Experimental Treatment 1 Intervention

Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Group II: Group 2 - Severe Hepatic Impairment Experimental Treatment 1 Intervention

Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Group III: Group 1 - Severe Renal Impairment Experimental Treatment 1 Intervention

Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Who Is Running the Clinical Trial?

Atea Pharmaceuticals, Inc.

Lead Sponsor

Trials

29

Recruited

4,600+

Citations

1. ir.ateapharma.com ir.ateapharma.com/news-releases/news-release-details/atea-pharmaceuticals-announces-full-results-phase-2-study

Atea Pharmaceuticals Announces Full Results from Phase 2 ... Conclusion: The Phase 2 study results demonstrated that an 8-week combination regimen BEM (550 mg) and RZR (180 mg) achieved SVR12 in 98% of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06911320

NCT06911320 | Study of Bemnifosbuvir/Ruzasvir as a ... 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 ...

3. biospace.com biospace.com/press-releases/atea-pharmaceuticals-presents-new-data-supporting-the-fixed-dose-combination-of-bemnifosbuvir-and-ruzasvir-as-a-potential-best-in-class-regimen-for-treatment-of-hepatitis-c-virus-infection-at-the-liver-meeting-2025

Atea Pharmaceuticals Presents New Data Supporting the ... Results from the Phase 2 study (n=275) evaluating the regimen of bemnifosbuvir and ruzasvir for 8 weeks showed a 98% SVR12 rate (210/215) with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12130360/

Results of a Phase 1 Study in Healthy Participants These results support the evaluation of the safety and efficacy of the bemnifosbuvir and ruzasvir combination for treating people with chronic HCV infections.

5. firstwordpharma.com firstwordpharma.com/story/6315059

Atea Pharmaceuticals to Present New Data Supporting ... Results from three Phase 1 studies presented at the EASL Congress 2025 demonstrated that the combination of bemnifosbuvir and ruzasvir had a low ...

6. ir.ateapharma.com ir.ateapharma.com/news-releases/news-release-details/atea-pharmaceuticals-presents-new-data-supporting-fixed-dose

News Release - Investor Relations | Atea Pharmaceuticals, Inc. Atea Pharmaceuticals Presents New Data Supporting the Fixed-Dose Combination of Bemnifosbuvir and Ruzasvir as a Potential Best-in-Class ...

7. withpower.com withpower.com/trial/phase-1-hepatic-impairment-3-2025-c1c39

Bemnifosbuvir/Ruzasvir for Liver Disease and Kidney Failure This study is for people with severe liver or kidney problems, as well as healthy individuals. Participants will receive a single dose of a combined medication ...