Table 3.
Steady‐state ribociclib (600 mg) PK parameters by PPI use
| Study no. | PK parameter | n | PPI use |
Geometric mean (geometric coefficient of variation, %) |
|---|---|---|---|---|
| X2107 | AUC0‐24h, h·ng/mL | 8 | Yes | 24,700 (30.6) |
| 10 | No | 21,100 (57.2) | ||
| Cmax, ng/mL | 10 | Yes | 1,780 (34.6) | |
| 13 | No | 1,620 (53.2) | ||
| X2101 | AUC0‐24h, h·ng/mL | 12 | Yes | 25,900 (79.1) |
| 46 | No | 23,700 (61.3) | ||
| Cmax, ng/mL | 13 | Yes | 2,050 (74.7) | |
| 48 | No | 1,870 (60.3) | ||
| X1101 | AUC0‐24h, h·ng/mL | 2 | Yes | 42,600 (28.7) |
| 6 | No | 55,100 (68.6) | ||
| Cmax, ng/mL | 2 | Yes | 2,700 (53.0) | |
| 6 | No | 3,500 (65.8) | ||
| A2301 | Ctrough, ng/mL | 8 | Yes | 587 (55.8) |
| 36 | No | 711 (72.9) |
AUC0‐24h, area under the concentration‐time curve from time zero to 24 h; Cmax, maximum concentration; Ctrough, trough concentration; PK, pharmacokinetics; PPI, proton pump inhibitor.