Summary statistics for PK parameters of 13C-odanacatib after single doses of 13C-odanacatib 1 mg i.v. with oral or i.v. doses of unlabeled odanacatib
| PK parameter | Dose of unlabeled odanacatib | ||||
|---|---|---|---|---|---|
| 1 mg i.v. (N = 20–24) | 10 mg fasted (N = 18–24) | 50 mg fasted (N = 18–24) | 50 mg low-fat meal (N = 9–12) | 50 mg high-fat meal (N = 9–12) | |
| Geometric mean (%CV) | |||||
| AUC0-∞a (µM-h) | 2.3 (30.7) | 2.4 (32.4) | 2.3 (23.1) | 2.7 (15.8) | 2.2 (26.7) |
| AUC0-lasta (µM-h) | 1.8 (34.3) | 1.8 (33.7) | 1.8 (32.8) | 2.0 (39.5) | 1.8 (36.0) |
| Ceoia (nM) | 52.6 (43.2) | 52.5 (34.1) | 55.9 (39.5) | 58.2 (27.5) | 54.9 (29.2) |
| Vssa (liters) | 114.8 (17.4) | 103.4 (19.7) | 93.8 (14.8) | 96.8 (17.3) | 88.6 (16.8) |
| Cla (l/h) | 0.8 (37.8) | 0.8 (40.5) | 0.8 (35.0) | 0.8 (41.6) | 0.9 (35.2) |
| Terminal t1/2b (h) | 108 (27.3) | 95.6 (29.9) | 81.7 (21.0) | 100.3 (19.9) | 73.9 (21.0) |
| AUC%extrapa | 10.7 (38.7) | 8.9 (57.8) | 7.6 (35.8) | 8.0 (46.3) | 6.5 (39.9) |
N is less than 24 for certain PK parameters because for some subjects, AUC0-∞ and t1/2 could not be determined due to insufficient data in the terminal phase. AUC0-last, AUC from 0 to last time point; AUC%extrap, percentage of AUC extrapolated beyond last time point; Cl, clearance.
↵a Geometric means for indicated parameters are directly calculated, not model-based.
↵b Harmonic mean (pseudo-S.D.).