A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323.
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Basic science
Enrollment
48actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-01-27 | actual | When the study began enrolling |
| Primary completion | 2025-05-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-01 | actual | The whole study's end, after follow-up |
| First posted | 2025-02-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- RSV Infection
- Drug Drug Interaction (DDI)
Interventions
- Drug: EDP-323
- Drug: Itraconazole
- Drug: EDP-323
- Drug: carbamazepine
- Drug: EDP-323
- Drug: Quinidine
- Drug: EDP-323
- Drug: fluconazole
Primary outcomes
what the primary-completion date above is the date OFCmax of EDP-323 with and without coadministration with Itraconazole
measured Day 1 through Day 19
AUC of EDP-323 with and without coadministration with Itraconazole
measured Day 1 through Day 19
Cmax of EDP-323 with and without coadministration with Carbamazepine
measured Day 1 through Day 28
AUC of EDP-323 with and without coadministration with Carbamazepine
measured Day 1 through Day 28
Cmax of EDP-323 with and without coadministration with Quinidine
measured Day 1 through Day 13
AUC of EDP-323 with and without coadministration with Quinidine
measured Day 1 through Day 13
Cmax of EDP-323 with and without coadministration with fluconazole
measured Day 1 through Day 19
AUC of EDP-323 with and without coadministration with fluconazole
measured Day 1 through Day 19
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