Table 6.
Summary of Baseline-Corrected Pharmacokinetic Parameters of Apolipoprotein A-I
| Pharmacokinetic Parameter | CSL112 1.7 g (n=7) | CSL112 3.4 g (n=12) | CSL112 6.8 g (n=14) | P Value (ANOVA) |
|---|---|---|---|---|
| Cmax, g/L | <0.001 | |||
| Mean (CV %) | 0.34 (26.9) | 0.77 (16.9) | 1.84 (19.1) | |
| Median (range) | 0.33 (0.23 to 0.49) | 0.79 (0.51 to 0.92) | 1.82 (1.26 to 2.38) | |
| Tmax, h | 0.12 | |||
| Mean (CV %) | 2.70 (57.8) | 2.03 (4.4) | 1.93 (13.5) | |
| Median (range) | 2.00 (2.0 to 6.2) | 2.00 (1.9 to 2.3) | 2.00 (1.0 to 2.0) | |
| AUC0-last, g·h/L | 0.005 | |||
| Mean (CV %) | 8.69 (85.3) | 20.44 (41.3) | 53.31 (33.9) | |
| Median (range) | 5.72 (1.22 to 19.93) | 20.83 (7.92 to 37.59) | 53.21 (17.78 to 87.41) | |
| AUC0-∞, g·h/L | 0.45 | |||
| Mean (CV %) | 4.02 (56.9) | 23.49 (49.5) | 63.78 (43.0) | |
| Median (range) | 4.47 (1.54 to 6.05) | 23.69 (8.57 to 48.16) | 58.85 (22.79 to 120.66) | |
| t1/2, h* | 0.48 | |||
| Mean (CV %) | 13.6 (81.6) | 29.6 (55.7) | 49.1 (62.1) | |
| Median (range) | 12.5 (3.2 to 25.3) | 23.2 (8.4 to 59.1) | 45.4 (15.9 to 123) |
ANOVA indicates analysis of variance; AUC, area under the curve; Cmax, observed maximum concentration in plasma; CV, coefficient of variance; t1/2, plasma half-life; Tmax, time to reach maximum concentration in plasma.
*
n=3, 9, and 13 in CSL112 1.7-, 3.4-, and 6.8-g groups, respectively.