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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05568706 | A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications. | PHASE2 | COMPLETED | 186 | — | — | Nov 29, 2022 | Jun 23, 2025 | Jul 1, 2025 | 84 | United States, Argentina +10 |
| NCT04871724 | Drug-Drug Interaction Study Between Fluconazole and EDP-938 in Healthy Subjects | PHASE1 | COMPLETED | 24 | — | — | Mar 12, 2021 | Apr 16, 2021 | May 4, 2021 | 1 | United States |
| NCT04498741 | Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects | PHASE1 | COMPLETED | 89 | — | — | Jul 8, 2020 | Jun 1, 2021 | Oct 13, 2021 | 1 | United States |
| NCT03755778 | Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects | PHASE1 | COMPLETED | 72 | — | — | Nov 29, 2018 | Jan 27, 2019 | Jun 14, 2019 | 1 | United States |
| NCT03750383 | Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects | PHASE1 | COMPLETED | 48 | — | — | Nov 2, 2018 | Dec 13, 2018 | Feb 12, 2019 | 1 | United States |
| NCT03384823 | A Study of EDP-938 in Healthy Subjects | PHASE1 | COMPLETED | 90 | — | — | Dec 7, 2017 | Jul 3, 2018 | Oct 10, 2018 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| EDP-938 | EXPERIMENTAL | EDP-938 800 mg, once daily |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, once daily |
| EDP-938 and Fluconazole interaction | EXPERIMENTAL | - |
| EDP-938 and tacrolimus interaction (Part 1) | EXPERIMENTAL | - |
| EDP-938 and dabigatran interaction (Part 2) | EXPERIMENTAL | - |
| EDP-938 and rosuvastatin interaction (Part 3) | EXPERIMENTAL | - |
| EDP-938 and midazolam interaction (Part 4) | EXPERIMENTAL | - |
| EDP-938 and itraconazole interaction (Part 1) | EXPERIMENTAL | - |
| EDP-938 and rifampin interaction (Part 2) | EXPERIMENTAL | - |
| EDP-938 and quinidine interaction (Part 3) | EXPERIMENTAL | - |
| EDP-938 and cyclosporine interaction (Part 1) | EXPERIMENTAL | - |
| EDP-938 and prednisone interaction (Part 2) | EXPERIMENTAL | - |
| EDP-938 SAD Cohorts | EXPERIMENTAL | EDP-938 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration |
| EDP-938 MAD Cohorts | EXPERIMENTAL | EDP-938 Dose 1, Dose 2, Dose 3, and Dose 4 oral suspension, once daily for 7 days |
| EDP-938 SAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral suspension, once daily in one single administration |
| EDP-938 MAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral suspension, once daily for 7 days |
| Name | Type | Description |
|---|---|---|
| EDP-938 | DRUG | Subjects will take EDP-938 once daily for 5 days |
| Placebo | DRUG | Subjects will take matching placebo, once daily for 5 days |
| Fluconazole | DRUG | Subjects will receive fluconazole once daily on Days 5 to 18 |
| Tacrolimus | DRUG | Subjects will receive tacrolimus once daily on Day 1 and Day 24 |
| Dabigatran | DRUG | Subjects will receive dabigatran once daily on Day 1 and Day 13 |
| Rosuvastatin | DRUG | Subjects will receive rosuvastatin once daily on Day 1 and Day 13 |
| Midazolam | DRUG | Subjects will receive midazolam once daily on Day 1 and Day 16 |
| Itraconazole | DRUG | Subjects will receive itraconazole once daily from Day 5 to Day 18 |
| Rifampin | DRUG | Subjects will receive rifampin once daily from Day 5 to Day 16 |
| Quinidine | DRUG | Subjects will receive quinidine once daily from Day 5 to Day 12 |
| Cyclosporine | DRUG | Subjects will receive one dose of cyclosporine on Day 5 |
| Prednisone | DRUG | Subjects will receive prednisone once daily from Day 5 to Day 14 |
Inclusion Criteria: * At least one of the following conditions that predispose them to complications after RSV infection: 1. Age ≥65 years 2. Congestive heart failure (CHF) 3. Asthma 4. Chronic obstructive pulmonary disease (COPD) * The subject has a new onset of any of the following sympt...