TABLE 3.
Statistical comparison of pharmacokinetic exposure parameters after co‐administration of EDP‐305 with different probes
| Treatment | N | Probe + EDP‐305 test | N | Probe alone reference | Geo LSMean ratio (90% CI) |
|---|---|---|---|---|---|
| Geo LSMean | Geo LSMean | ||||
| EDP‐305 as perpetrator | |||||
| Study 004 effect on midazolam | |||||
| Cmax, ng/ml | 24 | 9.41 | 24 | 7.51 | 1.25 (1.11, 1.41) |
| AUC0,inf, h ng/ml | 24 | 32.22 | 24 | 20.73 | 1.55 (1.32, 1.83) |
| Study 004 effect on caffeine | |||||
| Cmax, ng/ml | 24 | 4718 | 24 | 4191 | 1.13 (1.04, 1.21) |
| AUC0,inf, h ng/ml | 15 | 61,746 | 23 | 31,655 | 1.95 (1.61, 2.36) |
| Study 004 effect on rosuvastatin | |||||
| Cmax, ng/ml | 24 | 5.59 | 24 | 5.04 | 1.11 (0.94, 1.31) |
| AUC0,inf, h ng/ml | 22 | 61.19 | 22 | 49.49 | 1.24 (1.03, 1.48) |
| Study 008 effect on ethinyl estradiol | |||||
| Cmax, pg/ml | 31 | 148 | 35 | 137 | 1.08 (0.99, 1.19) |
| AUC0,t, h pg/ml | 31 | 1350 | 35 | 1250 | 1.08 (1.00, 1.16) |
| Study 008 effect on norelgestromin | |||||
| Cmax, pg/ml | 31 | 2470 | 35 | 2640 | 0.94 (0.86, 1.02) |
| AUC0,t, h pg/ml | 31 | 25,600 | 35 | 25,900 | 0.99 (0.92, 1.05) |
| Study 008 effect on levonorgestrel | |||||
| Cmax, pg/ml | 31 | 3850 | 35 | 2990 | 1.29 (1.21, 1.38) |
| AUC0,t, h pg/ml | 31 | 74,800 | 35 | 57,200 | 1.31 (1.23, 1.39) |
| Probe + EDP‐305 test | N | EDP‐305 alone reference | |||
|---|---|---|---|---|---|
| EDP‐305 as victim | |||||
| Study 005 itraconazole effect | |||||
| Cmax, ng/ml | 21 | 50.48 | 24 | 31.25 | 1.62 (1.28, 2.04) |
| AUC0,inf, h ng/ml | 18 | 1891.47 | 24 | 360.31 | 5.25 (4.26, 6.48) |
| Study 005 rifampin effect | |||||
| Cmax, ng/ml | 21 | 27.02 | 24 | 29.62 | 0.91 0.77, 1.08) |
| AUC0,inf, h ng/ml | 19 | 137.92 | 24 | 393.59 | 0.35 (0.30, 0.41) |
| Study 007 fluconazole effect | |||||
| Cmax, ng/ml | 24 | 57.71 | 24 | 32.73 | 1.76 (1.56, 1.99) |
| AUC0,inf, h ng/ml | 24 | 1537.60 | 24 | 408.40 | 3.77 (3.40, 4.17) |
| Study 007 quinidine effect | |||||
| Cmax, ng/ml | 24 | 31.78 | 24 | 31.64 | 1.00 (0.92, 1.10) |
| AUC0,inf, h ng/ml | 24 | 367.17 | 24 | 353.24 | 1.04 (0.95, 1.14) |
Abbreviations: AUC0,inf, area under the concentration curve from time 0 to infinity; CI, 90% confidence interval; Cmax, peak plasma concentration; Geo LSMean, geometric least square mean.