EDP-323 for Drug Interaction

CH
Overseen ByChris Harris, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Enanta 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 tests how a new treatment, EDP-323, interacts with three common substances: midazolam (a sedative), caffeine, and rosuvastatin (a cholesterol-lowering drug). The goal is to determine how EDP-323 affects the body's processing and safety of these substances. The trial seeks healthy adults without current illnesses and not taking medications that might interfere. Participants will receive all four substances during the trial to monitor any changes. As a Phase 1 trial, this research aims to understand how EDP-323 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves drug interactions, 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 EDP-323 is likely to be safe for humans?

Research has shown that EDP-323 is generally safe for people. In an earlier study, 14.6% of participants reported side effects, but most were mild and likely not caused by the drug. Some participants did experience side effects, but they were not serious and probably not due to EDP-323. As the treatment remains in early testing stages, researchers are closely monitoring safety. This focus on safety is a positive sign in understanding how safe EDP-323 is for people.12345

Why do researchers think this study treatment might be promising?

Most treatments for viral infections focus on directly attacking the virus or boosting the immune system. But EDP-323 works differently, targeting a specific protein that viruses use to replicate. This unique approach not only aims to stop the virus from multiplying but could also potentially make the treatment effective against a broader range of viral strains. Researchers are excited because this could lead to a more versatile and powerful way to manage viral infections, offering hope for quicker and more effective treatment options.

What evidence suggests that EDP-323 is effective for drug interaction?

Research has shown that EDP-323 may help treat respiratory syncytial virus (RSV) infections. Studies have found it can prevent RSV infection if taken within five days of exposure to the virus. Early results suggest it is safe and generally well-tolerated by healthy individuals. This treatment targets a specific protein in the virus, which helps stop the virus from multiplying. Although most data comes from studies on RSV, these findings suggest it could be effective.24567

Who Is on the Research Team?

EP

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 EDP-323 interacts with other drugs. Specific eligibility criteria are not provided, but typically participants should have no significant health issues that could affect the study's results.

Inclusion Criteria

An informed consent document signed and dated by the subject
I weigh more than 50 kg and my BMI is between 18 and 32.
I agree to use two forms of birth control during and 30 days after the trial.

Exclusion Criteria

I have a history of significant illness.
Pregnant or nursing females
I haven't had a fever or active infection in the last 7 days.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EDP-323, midazolam, caffeine, and rosuvastatin on respective dosing days

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • EDP-323
Trial Overview The trial is testing how EDP-323 affects the body's handling of three different substances: midazolam (a sedative), caffeine (a stimulant), and rosuvastatin (a cholesterol-lowering drug).
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: EDP-323, midazolam, caffeine and rosuvastatinExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Enanta Pharmaceuticals, Inc

Lead Sponsor

Trials
42
Recruited
3,200+

Published Research Related to This Trial

CYP3A4 inhibitors, such as itraconazole and grapefruit juice, can significantly alter the metabolism of various medications, leading to potentially dangerous interactions like torsades de pointes when combined with certain drugs like terfenadine or cisapride.
While many interactions can lead to adverse effects, some can be beneficial, such as using CYP3A4 inhibitors to enhance the effectiveness of drugs like cyclosporin, highlighting the importance of understanding individual patient factors in managing drug interactions.
Pharmacokinetic-pharmacodynamic consequences and clinical relevance of cytochrome P450 3A4 inhibition.Dresser, GK., Spence, JD., Bailey, DG.[2022]
Drug interactions often occur due to changes in how the body eliminates medications, particularly through specific enzymes like cytochrome P450 and transporters like P-glycoprotein, which can lead to either reduced effectiveness or increased toxicity of drugs.
Preventing adverse drug interactions can be achieved by avoiding the use of certain medications together or by considering alternative treatments, highlighting the importance of understanding both the drugs involved and the individual patient's characteristics.
A basic conceptual and practical overview of interactions with highly prescribed drugs.Dresser, GK., Bailey, DG.[2018]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40293399/
EDP-323, a First-In-Class, Once-Daily, Oral L-Protein ...EDP-323 demonstrated a favorable safety and PK profile, supporting its potential as a once-daily oral treatment for RSV. Keywords: clinical trials; healthy ...
NCT06847464 | A Drug-Drug Interaction Study to Evaluate ...The primary aim of the study is to assess the effect of itraconazole, carbamazepine, quinidine, and fluconazole individually on the pharmacokinetics and safety ...
Enanta Pharmaceuticals Presents New Data for Zelicapavir ...These data suggest that EDP-323 is highly effective in preventing RSV infection when initiated up to 5 days after RSV exposure and further ...
EDP‐323, a First‐In‐Class, Once‐Daily, Oral L‐Protein ...In this phase 1 study, single ascending doses and multiple ascending doses of EDP-323 up to 800 mg were generally well tolerated in healthy ...
A Controlled Phase 2a Study to Evaluate the Efficacy of EDP ...This study is designed to assess the antiviral effect of EDP-323 compared to a placebo control in the respiratory syncytial virus challenge ...
A Study to Evaluate the Drug-Drug Interaction of EDP-323 ...The primary aim of this study is to assess the effect of EDP-323 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy adult ...
EDP-323 for Drug Interaction · Info for ParticipantsThe primary aim of this study is to assess the effect of EDP-323 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy adult ...
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