TABLE 2.
Mean (SD) Cmax and percent of hydroxyapatite crystallization by treatment and visit.
| Treatment | Value | Week 1 | Week 10 | Week 22 | Week 52 | Average |
|---|---|---|---|---|---|---|
| Cmax, µM | ||||||
| Placebo | n | 8 | 9 | 10 | 8 | 35 |
| Mean (SD) | BLQ | BLQ | BLQ | BLQ | BLQ | |
| 300 mg | n | 13 | 12 | 11 | 11 | 47 |
| Mean (SD) | 13.3 (9.1) | 14.3 (9.6) | 16.4 (9.3) | 15.0 (11.5) | 14.7 (9.6) | |
| 600 mg | n | 9 | 9 | 15 | 6 | 39 |
| Mean (SD) | 39.4 (24.7) | 44.2 (18.7) | 43.7 (19.1) | 62.7 (24.3) | 45.8 (21.7) | |
| PD effect, % | ||||||
| Placebo | n | 9 | 10 | 9 | 8 | 36 |
| Mean (SD) | 18.7 (18.2) | 16.8 (18.8) | 19.4 (11.9) | 3.5 (16.5) | 15.0 (17.1) | |
| 300 mg | n | 11 | 12 | 11 | 10 | 44 |
| Mean (SD) | 51.4 (22.4) | 65.0 (10.0) | 62.4 (20.4) | 63.3 (19.2) | 60.6 (18.6) | |
| 600 mg | n | 9 | 9 | 15 | 7 | 40 |
| Mean (SD) | 72.3 (9.6) | 75.5 (7.8) | 75.4 (9.4) | 78.5 (7.7) | 75.2 (8.7) | |
n, number of samples.
BLQ, below limit of quantification (0.76 µM).
Average, arithmetic mean of all values obtained in week 1, 10, 22, and 52.
PD effect, pharmacodynamic effect, measured as inhibition of hydroxyapatite crystallization.