TABLE 3.
Change in PK parameters of coadministered ritlecitinib in the presence of itraconazole and rifampicin.
| Dose of coadministered drug | AUCinf (ng h/mL) | AUClast (ng h/mL) | Cmax (ng/mL) | |
|---|---|---|---|---|
| Effect of itraconazole (CYP3A inhibitor) on PK of ritlecitinib | ||||
| Ritlecitinib a 30 mg | Adjusted geometric mean (test, 200 mg QD × 5 days) | 308.0 | 303.9 | 156.5 |
| Adjusted geometric mean (reference) | 267.5 | 264.2 | 152.6 | |
| Ratio, % (test/reference) of adjusted geometric means (90% CI) | 115.1 (104.6–126.7) | 115.1 (104.4–126.7) | 102.5 (82.8–127.0) | |
| Effect of rifampicin (CYP3A inducer) on PK of ritlecitinib | ||||
| Ritlecitinib a 50 mg | Adjusted geometric mean (test, 600 mg QD × 8 days) | 250.5 | 249.4 | 204.4 |
| Adjusted geometric mean (reference) | 449.3 | 448.1 | 272.3 | |
| Ratio, % (test/reference) of adjusted geometric means (90% CI) | 55.8 (51.9–59.9) | 55.7 (51.9–59.7) | 75.1 (63.3–89.1) | |
Abbreviations: AUC, area under the plasma concentration–time curve; CI, confidence interval; Cmax, maximum concentration; PK, pharmacokinetics; QD, once daily.
a
Descriptive statistics of all reported PK parameters are provided in Table S3.