Drug Interaction Study with Bemnifosbuvir/Ruzasvir
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the interaction between two medications, Bemnifosbuvir/Ruzasvir (BEM/RZR), and Buprenorphine/Naloxone and Methadone, commonly used for opioid addiction treatment. The goal is to determine if taking these drugs together alters their effects in the body. Individuals currently on Buprenorphine/Naloxone or Methadone for maintenance therapy and willing to follow the study guidelines may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to early-stage medical research.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking other prescription or over-the-counter medications, except for methadone or buprenorphine/naloxone if they are part of your assigned maintenance therapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that the combination of bemnifosbuvir and ruzasvir is generally well-tolerated in healthy individuals. Research indicates a low risk of these drugs interacting with each other or other medications when taken together.
Earlier studies did not report significant side effects from this combination. The main goal of this new trial is to examine how these drugs interact with buprenorphine/naloxone and methadone, which treat addiction.
Overall, available research suggests that bemnifosbuvir and ruzasvir are safe to use, as previous studies have not raised major safety concerns.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Bemnifosbuvir and Ruzasvir because these treatments represent a novel approach to managing conditions typically addressed with opioid-based therapies. Unlike traditional methods, which rely heavily on medications like buprenorphine/naloxone or methadone alone, Bemnifosbuvir/Ruzasvir offers a fresh strategy by potentially enhancing the effectiveness of these treatments through unique antiviral properties. This could mean better outcomes for individuals who are managing co-occurring conditions that require opioid treatments, and it holds promise for addressing complex cases with a dual-action approach.
What evidence suggests that this trial's treatments could be effective?
Research has shown that the combination of the drugs bemnifosbuvir and ruzasvir is very promising in fighting hepatitis C. In a previous study with 275 participants, 98% had no detectable virus 12 weeks after treatment, demonstrating the treatment's high effectiveness in clearing the virus. These drugs work synergistically, enhancing their potency. Early tests also indicate that they are generally safe for use. In this trial, participants will receive bemnifosbuvir/ruzasvir combined with either buprenorphine/naloxone or methadone to study potential drug interactions.12346
Are You a Good Fit for This Trial?
This trial is for healthy volunteers who are interested in participating in a study to understand how Bemnifosbuvir/Ruzasvir (BEM/RZR) interacts with other drugs. Specific eligibility criteria details were not provided, so participants should inquire about any additional requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multiple oral doses of BEM/RZR in combination with either buprenorphine/naloxone or methadone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bemnifosbuvir/Ruzasvir
Trial Overview
The study is testing the interactions between a combination of two medications, BEM/RZR and either Buprenorphine/Naloxone or Methadone. It aims to see if there are any changes when these drugs are taken together.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Atea Pharmaceuticals, Inc.
Lead Sponsor
Citations
1.
ir.ateapharma.com
ir.ateapharma.com/news-releases/news-release-details/atea-pharmaceuticals-presents-new-data-supporting-fixed-doseNews 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 Participants
Overall, the combination of bemnifosbuvir and ruzasvir exhibited a safety profile in healthy participants that was consistent with the administration of these ...
In Vitro and Clinical Evaluation of Potential Interactions of ...
Simultaneous administration of a single dose of 1100 mg bemnifosbuvir increased total plasma exposure of both drugs by less than 20%, and ...
Bemnifosbuvir and ruzasvir in combination exhibit potent ...
Bemnifosbuvir and ruzavir are potent inhibitors of hepatitis C virus. These antiviral drugs act synergistically in vitro when combined.
Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir
Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of primary purpose are: ...
Efficacy and Safety of Bemnifosbuvir and Ruzasvir After 8 ...
Lack of pharmacokinetic drug-drug interaction between bemnifosbuvir and ruzasvir in healthy participants · Bemnifosbuvir Does Not Alter ...
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