TABLE 1.
Summary of drug interaction studies conducted with EDP‐305
| Study | EDP‐305 | Probe substrate | |||
|---|---|---|---|---|---|
| Dose/Formulation | Days | Substrate/Dose | Days | CYP or transporter | |
| EDP‐305 as perpetrator | |||||
| 1 | 10 mg/suspension | 5 to 15 |
Midazolam 2 mg Caffeine 200 mg Rosuvastatin 20 mg |
1 and 12 1 and 12 2 and 13 |
CYP3A4 CYP1A2 BRCP/OATP1B1/OATP1B3 |
| 2 | 2.5 mg/tablet | 11 to 21 of cycle 3 | Ethinyl estradiol/norgestimate | 1 to 21 of cycles 1, 2, 3 | CYP3A4 |
| EDP‐305 as victim | |||||
| 3 | 5 mg/tablet |
1 and 14 1 and 8 |
Fluconazole 400 mg QD Quinidine 300 mg BID |
5 to 18 5 to 12 |
CYP3A4 P‐gp |
| 4 | 10 mg/suspension | 1 and 14 |
Itraconazole 200 mg q.d. Rifampin 600 mg q.d. |
5 to 18 5 to 16 |
CYP3A4 CYP3A4 |