EDP-323 for Respiratory Syncytial Virus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how EDP-323, an experimental treatment, interacts with certain drugs in the body. It focuses on healthy individuals who wish to assist researchers in learning more about treating respiratory syncytial virus (RSV), a common virus that can cause serious lung issues. Participants will take EDP-323 alongside one of four other drugs—itraconazole, carbamazepine, quinidine, or fluconazole—to observe their interactions. This trial suits healthy individuals who do not smoke and have not been sick recently. 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 treatment.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications. However, since the study involves assessing the effect of certain drugs on EDP-323, it's possible that some medications might need to be paused. Please consult with the trial coordinators for specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that EDP-323 is generally safe and well-tolerated. Earlier studies found EDP-323 to be safe and effective, reducing the virus in the body by 85-87%. This indicates it works well against the virus with minimal side effects.
The study aims to examine how EDP-323 interacts with other drugs like itraconazole, carbamazepine, quinidine, and fluconazole. EDP-323 itself has already been shown to be safe, which can reassure those considering joining the trial, as it indicates prior testing confirmed its safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about EDP-323 for respiratory syncytial virus (RSV) because it offers a novel approach compared to current treatments like ribavirin and palivizumab. While most existing options focus on symptom management or prevention, EDP-323 could potentially target the virus more directly, offering a different mechanism of action. This investigational drug is being studied for its interactions with other medications like quinidine, fluconazole, carbamazepine, and itraconazole, which might help optimize its effectiveness and safety profile. This tailored interaction study could pave the way for more personalized and effective RSV treatments.
What evidence suggests that this trial's treatments could be effective for Respiratory Syncytial Virus?
Research has shown that EDP-323 is promising in fighting respiratory syncytial virus (RSV). Studies have found that EDP-323 can significantly reduce RSV symptoms, with a 66% to 78% decrease in symptom severity compared to a placebo. It also achieved an 85-87% reduction in the virus's presence in the body. EDP-323 targets a part of the virus that aids in its reproduction. This trial will explore EDP-323's interactions with other medications, such as quinidine, fluconazole, carbamazepine, and itraconazole, to further understand its potential as an effective RSV treatment.13678
Who Is on the Research Team?
Enanta Pharmaceuticals, Inc
Principal Investigator
Enanta Pharmaceuticals, Inc
Are You a Good Fit for This Trial?
This trial is for healthy adults who can participate in a study to understand how certain drugs affect the body's handling and safety of EDP-323, which is being investigated for Respiratory Syncytial Virus. Specific eligibility criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive EDP-323 in combination with either itraconazole, carbamazepine, quinidine, or fluconazole on respective dosing days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EDP-323
Find a Clinic Near You
Who Is Running the Clinical Trial?
Enanta Pharmaceuticals, Inc
Lead Sponsor