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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06917508 | A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants | PHASE1 | COMPLETED | 24 | — | — | Mar 13, 2025 | Jun 13, 2025 | Jul 1, 2025 | 1 | United States |
| NCT06847464 | A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323. | PHASE1 | COMPLETED | 48 | — | — | Jan 27, 2025 | Jun 1, 2025 | Jul 1, 2025 | 1 | United States |
| NCT05587478 | A Study of EDP-323 in Healthy Subjects | PHASE1 | COMPLETED | 82 | — | — | Sep 29, 2022 | Mar 29, 2023 | Sep 1, 2023 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| EDP-323, midazolam, caffeine and rosuvastatin | EXPERIMENTAL | Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days |
| EDP-323 and itraconazole interaction (Part 1) | EXPERIMENTAL | Subjects will receive EDP-323 and itraconazole on respective dosing days |
| EDP-323 and carbamazepine interaction (Part 2) | EXPERIMENTAL | Subjects will receive EDP-323 and carbamazepine on respective dosing days |
| EDP-323 and quinidine interaction (Part 3) | EXPERIMENTAL | Subjects will receive EDP-323 and quinidine on respective dosing days |
| EDP-323 and fluconazole interaction (Part 4) | EXPERIMENTAL | Subjects will receive EDP-323 and fluconazole on respective dosing days |
| EDP-323 SAD Cohorts | EXPERIMENTAL | EDP-323 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6, orally, once daily in one single administration |
| EDP-323 MAD Cohorts | EXPERIMENTAL | EDP-323 Dose 1, Dose 2, Dose 3 and Dose 4 orally, once daily for 7 days |
| EDP-323 SAD Placebo Cohorts | PLACEBO_COMPARATOR | Matching placebo, orally, once daily in one single administration |
| EDP-323 MAD Placebo Cohorts | PLACEBO_COMPARATOR | Matching placebo, orally, once daily for 7 days |
| Name | Type | Description |
|---|---|---|
| EDP-323 | DRUG | Subjects will receive EDP-323 once daily on Days 5-15 |
| Midazolam | DRUG | Subjects will receive midazolam once daily on Days 1 and 12 |
| Caffeine | DRUG | Subjects will receive caffeine once daily on Days 1 and 12 |
| Rosuvastatin | DRUG | Subjects will receive rosuvastatin once daily on Days 2 and 13 |
| Itraconazole | DRUG | Subjects will receive itraconazole QD Days 5-18 |
| carbamazepine | DRUG | Subjects will receive carbamazepine on Days 5 - 27 |
| Quinidine | DRUG | Subjects will receive quinidine on Days 5-12 |
| fluconazole | DRUG | Subjects will receive fluconazole on Days 5-18 |
| Placebo | DRUG | Placebo to match EDP-323, oral administration |
Inclusion Criteria: * An informed consent document signed and dated by the subject * Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive * Screening body weight \>50 kg and body mass index (BMI) of 18 to 32 kg/m2 * Female subjects of childbearing pot...