COMPLETED

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-13

Study Completion:2025-06-13

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06917508

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Enanta Pharmaceuticals, Inc

STUDY_DIRECTOR

Enanta Pharmaceuticals, Inc

Study Locations (Sites)

ICON, plc

San Antonio, Texas, 78209

United States

Collaborators and Investigators

Sponsor: Enanta Pharmaceuticals, Inc

Enanta Pharmaceuticals, Inc, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2025-03-13

Study Completion Date2025-06-13

Study Record Updates

Study Start Date2025-03-13

Study Completion Date2025-06-13

Terms related to this study

Keywords Provided by Researchers

Drug Drug Interaction

Additional Relevant MeSH Terms

RSV Infection
Drug Drug Interaction