A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants

June 26, 2025 updated by: Enanta Pharmaceuticals, Inc

A Non-Randomized, Multiple-Dose, Open-Label, Single Sequence Study to Evaluate the Effect of Concomitant Administration of EDP-323 on the Pharmacokinetics and Safety of Midazolam, Caffeine, and Rosuvastatin in Healthy Participants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • ICON, plc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • An informed consent document signed and dated by the subject
  • Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive
  • Screening body weight >50 kg and body mass index (BMI) of 18 to 32 kg/m2
  • Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of EDP-323. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

Exclusion Criteria:

  • Clinically relevant evidence or history of illness or disease
  • Pregnant or nursing females
  • History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection
  • Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
  • Positive for HIV or hepatitis
  • Positive urine drug screen
  • Current tobacco smokers or use of tobacco within 3 months prior to Screening.
  • Received any vaccine, an investigational agent, or biological product within 28 days or 5 times the t½ of receipt of study drug, whichever is longer.
  • Drug sensitivity to midazolam, caffeine, rosuvastatin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EDP-323, midazolam, caffeine and rosuvastatin
Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days
Drug: Midazolam
Subjects will receive midazolam once daily on Days 1 and 12
Drug: Rosuvastatin
Subjects will receive rosuvastatin once daily on Days 2 and 13
Drug: Caffeine
Subjects will receive caffeine once daily on Days 1 and 12
Drug: EDP-323
Subjects will receive EDP-323 once daily on Days 5-15

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323
Time Frame: Up to 17 Days
Up to 17 Days
AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323
Time Frame: Up to 17 Days
Up to 17 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety measured by adverse events
Time Frame: Up to 22 days
Up to 22 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enanta Pharmaceuticals, Inc

Investigators

  • Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2025

Primary Completion (Actual)

June 6, 2025

Study Completion (Actual)

June 13, 2025

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 26, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDP 323-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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