Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05616728 | A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19 | PHASE2 | COMPLETED | 231 | — | — | Nov 10, 2022 | Jun 29, 2023 | Aug 19, 2024 | 23 | United States, Romania |
| NCT05594602 | Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects. | PHASE1 | COMPLETED | 36 | — | — | Oct 6, 2022 | Dec 30, 2022 | Apr 27, 2023 | 1 | United States |
| NCT05594615 | Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects | PHASE1 | COMPLETED | 24 | — | — | Oct 6, 2022 | Nov 18, 2022 | Apr 27, 2023 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| EDP-235 200mg | EXPERIMENTAL | Once a day orally for 5 days |
| EDP-235 400mg | EXPERIMENTAL | Once a day orally for 5 days |
| Placebo | PLACEBO_COMPARATOR | Once a day orally for 5 days |
| EDP-235 and Itraconazole interaction (Part 1) | EXPERIMENTAL | Subjects will receive EDP-235 and Itraconazole on respective dosing days |
| EDP-235 and Carbamazepine interaction (Part 2) | EXPERIMENTAL | Subjects will receive EDP-235 and Carbamazepine on respective dosing days |
| EDP and Quinidine interaction (Part 3) | EXPERIMENTAL | Subjects will receive EDP-235 and Quinidine on respective dosing days |
| EDP-235, midazolam, rosuvastatin and caffeine | EXPERIMENTAL | Subjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days |
| Name | Type | Description |
|---|---|---|
| EDP-235 | DRUG | capsule |
| Placebo | DRUG | capsule |
| Itraconazole | DRUG | Subjects will receive itraconazole QD Days 5-18 |
| Carbamazepine | DRUG | Subjects will receive carbamazepine BID Days 5-23 and Days 24-27 |
| Quinidine | DRUG | Subjects will receive quinidine BID Days 5-12 |
| Midazolam | DRUG | Subjects will receive midazolam once daily on Days 1 and 12 |
| Rosuvastatin | DRUG | Subjects will receive rosuvastatin once daily on Days 2 and 13 |
| Caffeine | DRUG | Subjects will receive caffeine once daily on Days 1 and 12 |
Inclusion Criteria: * SARS-CoV-2 infection confirmed by positive test ≤24 hours before randomization * COVID-19 symptom onset within 5 days prior to randomization and at least 2 signs/symptoms attributable to COVID-19 present and one of at least moderate severity at Screening Exclusion Criteria: ...