Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects

April 25, 2023 updated by: Enanta Pharmaceuticals, Inc

A NON-RANDOMIZED, MULTIPLE-DOSE, OPEN-LABEL, SINGLE SEQUENCE STUDY TO EVALUATE THE EFFECT OF CONCOMITANT ADMINISTRATION OF EDP-235 ON THE PHARMACOKINETICS AND SAFETY OF MIDAZOLAM, CAFFEINE, AND ROSUVASTATIN IN HEALTHY PARTICIPANTS

A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.

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
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • 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

14 years to 51 years (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 55 years, inclusive
  • Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
  • Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-235. 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
  • A positive urine drug screen at Screening or Day -1
  • Current tobacco smokers or use of tobacco within 3 months prior to Screening.
  • Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
  • History of regular alcohol consumption
  • Participation in a clinical trial within 30 days prior to the first dose of study drug
  • History of drug allergy to midazolam, caffeine, or 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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EDP-235, midazolam, rosuvastatin and caffeine
Subjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days
Drug: EDP-235
Subjects will receive EDP-235 once daily on Days 5-15
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

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-235
Time Frame: Up to 17 Days
Up to 17 Days
AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235
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

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)

October 6, 2022

Primary Completion (Actual)

November 4, 2022

Study Completion (Actual)

November 18, 2022

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria

October 21, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDP 235-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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