NCT06917508

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• RSV Infection
• Drug Drug Interaction

Interventions

Type	Name	Description
DRUG	EDP-323	Subjects will receive EDP-323 once daily on Days 5-15
DRUG	Midazolam	Subjects will receive midazolam once daily on Days 1 and 12
DRUG	Caffeine	Subjects will receive caffeine once daily on Days 1 and 12
DRUG	Rosuvastatin	Subjects will receive rosuvastatin once daily on Days 2 and 13

Timeline

• Start date: 2025-03-13
• Primary completion: 2025-06-06
• Completion: 2025-06-13
• First posted: 2025-04-08
• Last updated: 2025-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study