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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03610945 | Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers | PHASE1 | COMPLETED | 48 | — | — | Jul 19, 2018 | Aug 21, 2018 | Dec 5, 2018 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| EDP-305 and fluconazole interaction (Part 1) | EXPERIMENTAL | - |
| EDP-305 and quinidine interaction (Part 2) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Fluconazole | DRUG | Subjects will receive fluconazole once daily from Day 5 to Day 18 |
| Quinidine | DRUG | Subjects will receive quinidine twice daily from Day 5 to Day 12 |
| EDP-305 | DRUG | Subjects will receive a single dose of EDP-305 on Day 1 and Day 14 |
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 55 years, inclusive. * Female subjects must be of non-childbearing potential. Exclusion Criteria: * Clinically relevant evidence o...