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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04783753 | Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects | PHASE1 | COMPLETED | 72 | — | — | Nov 5, 2020 | Jul 9, 2021 | Aug 16, 2021 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| EDP-514 and Itraconazole interaction (Part 1) | EXPERIMENTAL | - |
| EDP-514 and Carbamazepine interaction (Part 2) | EXPERIMENTAL | - |
| EDP-514 and Quinidine interaction (Part 3) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| EDP-514 | DRUG | Subjects will receive EDP-514 on Days 1 and 14 |
| Itraconazole | DRUG | Subjects will receive itraconazole QD for 14 days |
| Carbamazepin | DRUG | Subjects will receive carbamazepine BID for 23 days |
| Quinidine | DRUG | Subjects will receive quinidine BID for 8 days |
Inclusion Criteria: * An informed consent document signed and dated by the subject. * Male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive * Female subjects who are heterosexually active and of childbearing potential must agree to use two effective methods of...