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

Phase 1

Recruiting

• Conditions: RSV Infection; Drug Drug Interaction
• Interventions: Drug: EDP-323; Drug: Midazolam; Drug: Caffeine; Drug: Rosuvastatin

• Registration Number: NCT06917508
• Lead Sponsor: Enanta Pharmaceuticals, Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EDP-323, midazolam, caffeine and rosuvastatin	EDP-323	Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days
EDP-323, midazolam, caffeine and rosuvastatin	Midazolam	Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days
EDP-323, midazolam, caffeine and rosuvastatin	Caffeine	Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days
EDP-323, midazolam, caffeine and rosuvastatin	Rosuvastatin	Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days

Primary Outcome Measures

Name	Time	Method
Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323	Up to 17 Days
AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323	Up to 17 Days

Secondary Outcome Measures

Name	Time	Method
Safety measured by adverse events	Up to 22 days

Trial Locations

Locations (1)

ICON, plc; 🇺🇸 San Antonio, Texas, United States