EDP-323 for Drug Interaction

Overseen By Chris Harris, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Enanta Pharmaceuticals, Inc

Disqualifiers: HIV, Hepatitis, Tobacco use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

24 Participants Needed

Trial Summary

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.

What makes the drug EDP-323 unique compared to other treatments?

EDP-323 is unique because it may involve interactions with the enzyme CYP3A4, which is responsible for metabolizing many drugs in the body. This could affect how EDP-323 is processed and its effectiveness, making it different from other treatments that do not interact with this enzyme. ^{1 2 3 4 5}

What is the purpose of this trial?

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 participants.

Research Team

Enanta Pharmaceuticals, Inc

Principal Investigator

Enanta Pharmaceuticals, Inc

Eligibility Criteria

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.

Timeline

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

Treatment Details

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).

Participant Groups

Group I: EDP-323, midazolam, caffeine and rosuvastatin Experimental Treatment 4 Interventions

Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days

Who Is Running the Clinical Trial?

Enanta Pharmaceuticals, Inc

Lead Sponsor

Trials

42

Recruited

3,200+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A basic conceptual and practical overview of interactions with highly prescribed drugs. Dresser, GK., Bailey, DG.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetic-pharmacodynamic consequences and clinical relevance of cytochrome P450 3A4 inhibition. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

[Drug interactions and clinical relevance: it all began with cheese]. [2012]

3. England pubmed.ncbi.nlm.nih.gov

The pharmacokinetic study on the interaction between nobiletin and anemarsaponin BII in vivo and in vitro. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

A basic conceptual and practical overview of interactions with highly prescribed drugs. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Pharmacy-based computer system for monitoring and reporting drug interactions. [2004]