Bemnifosbuvir/Ruzasvir for Drug Interaction Study

AS
Overseen ByAtea Study Clinical Trials Administrator
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Atea Pharmaceuticals, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how the combination of two drugs, Bemnifosbuvir and Ruzasvir, interacts with either Digoxin or Rosuvastatin, medications commonly used for heart conditions and cholesterol. Participants will help researchers understand any effects these drugs might have on each other when taken together. The trial seeks individuals willing to follow strict study rules, including using two forms of birth control and avoiding other medications. It suits those who are generally healthy, with a minimum weight of 110 pounds and a body mass index (BMI) between 18 and 30. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current prescription and over-the-counter medications to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Bemnifosbuvir and Ruzasvir are generally safe when used together. Studies have found that this combination is unlikely to cause problems when taken with other medications. Earlier trials with healthy volunteers demonstrated that participants tolerated these drugs well, without major issues. Animal studies also revealed no major safety concerns. These findings suggest that Bemnifosbuvir and Ruzasvir are likely safe for humans.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Bemnifosbuvir and Ruzasvir because these treatments offer a fresh approach to managing drug interactions, particularly with common medications like digoxin and rosuvastatin. Unlike other treatments that may not effectively address the complexities of drug interactions, Bemnifosbuvir and Ruzasvir are being studied for their potential to minimize adverse interactions while maintaining efficacy. This could be a game-changer for patients who rely on multiple medications, as it aims to optimize safety and therapeutic outcomes.

What evidence suggests that this trial's treatments could be effective?

Research has shown that the combination of bemnifosbuvir and ruzasvir effectively treats certain viral infections. One study found that 98% of patients had no detectable virus in their blood 12 weeks after completing treatment, indicating strong efficacy. The combination was also safe in healthy individuals, with no major issues reported. This trial focuses on how bemnifosbuvir and ruzasvir interact with other drugs, such as Digoxin and Rosuvastatin, in different treatment arms. While current research examines these interactions, previous results are promising for treating infections.12346

Are You a Good Fit for This Trial?

This trial is for healthy volunteers who weigh at least 50 kg with a BMI of 18-30. Participants must use two birth control methods from screening until 90 days after the last dose and agree to follow study rules.

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 weigh at least 50 kg and my BMI is between 18-30.

Exclusion Criteria

Abuse of alcohol or drugs
Use of other investigational drugs within 28 days of dosing
Presence of other clinically significant medical conditions or laboratory abnormalities
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of Bemnifosbuvir/Ruzasvir and are monitored for drug-drug interactions with Digoxin and Rosuvastatin

1 day

Follow-up

Participants are monitored for safety and pharmacokinetics after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bemnifosbuvir/Ruzasvir
Trial Overview The study tests how Bemnifosbuvir/Ruzasvir (BEM/RZR) affects the body's handling of Digoxin and Rosuvastatin, alone or combined. It compares taking these drugs separately versus together, immediately or delayed by two hours.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Rosuvastatin vs Rosuvastatin + BEM/RZR vs Rosuvastatin + 2h BEM/RZRExperimental Treatment1 Intervention
Group II: Digoxin vs Digoxin + BEM/RZR vs Digoxin + 2h BEM/RZRExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Atea Pharmaceuticals, Inc.

Lead Sponsor

Trials
29
Recruited
4,600+

Citations

News Release - Investor Relations | Atea Pharmaceuticals, Inc.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 ...
Results of a Phase 1 Study in Healthy ParticipantsOverall, the combination of bemnifosbuvir and ruzasvir exhibited a safety profile in healthy participants that was consistent with the administration of these ...
Bemnifosbuvir and ruzasvir in combination exhibit potent ...The results of the 13-week rat study demonstrate the safety and lack of extensive drug-drug interactions of BEM and RZR at dose levels of each drug that far ...
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir ...It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...
Atea Pharmaceuticals Announces Full Results from Phase 2 ...Full results from Phase 2 study confirmed 98% sustained virologic response at 12 weeks post-treatment (SVR12) after short 8-week treatment duration for regimen.
Clinical Evaluation of Potential Interaction Between ...Clinical studies have demonstrated favorable efficacy and safety of bemnifosbuvir and ruzasvir in combination with other NS5A and NS5B ...
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