A Phase 1 interventional study of EDP-323 and Midazolam in RSV Infection and Drug Drug Interaction, sponsored by Enanta Pharmaceuticals, Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Enanta Pharmaceuticals, Inc · Phase 1, Interventional, and Basic science
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.
293 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 45 are open to participants now.
This study's enrollment of 24 is below the median of 90 across 213 interventional studies indexed under Respiratory Syncytial Virus Infections.
Browse Respiratory Syncytial Virus Infections studies →Enanta Pharmaceuticals, Inc is the lead sponsor of 45 studies on the registry; 2 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days
Drug: EDP-323 · Drug: Midazolam · Drug: Caffeine · Drug: Rosuvastatin
Subjects will receive EDP-323 once daily on Days 5-15
Subjects will receive midazolam once daily on Days 1 and 12
Subjects will receive caffeine once daily on Days 1 and 12
Subjects will receive rosuvastatin once daily on Days 2 and 13
Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323
Time frame: Up to 17 Days
AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323
Time frame: Up to 17 Days
Safety measured by adverse events
Time frame: Up to 22 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Respiratory Syncytial Virus Infections→
Enanta Pharmaceuticals, Inc