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

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.

Conditions

RSV Infection, Drug Drug Interaction

Study Overview

Study Details

Study overview

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.

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

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

Condition
RSV Infection
Intervention / Treatment

-

Contacts and Locations

San Antonio

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Enanta Pharmaceuticals, Inc,

Enanta Pharmaceuticals, Inc, STUDY_DIRECTOR, Enanta Pharmaceuticals, Inc

Study Record Dates

2025-06