Table 6.
Summary statistics of plasma PK parameters of QAW039 on Days 1 and 28 (PK analysis set).
| Day | Statistic | Tmax (h)a | Cmax (ng/mL) | AUCtaub (h*ng/mL) | Cav (ng/mL) | Cmin (ng/mL) | Racc AUCtauc | Ratio Cmaxd |
|---|---|---|---|---|---|---|---|---|
| 1 | N | 73 | 73 | 73 | 73 | |||
| Mean (SD) | 1.08 | 3610 (1900) | 12,000 (5500) | 502 (229) | NC | NC | NC | |
| CV% | (0.47, 6.00) | 52.6 | 45.7 | 45.7 | ||||
| 28 | N | 71 | 71 | 70 | 70 | 71 | 66 | 67 |
| Mean (SD) | 1.13 | 3440 (1850) | 14,300 (6090) | 595 (254) | 118 (104) | 1.23 (0.271) | 1.13 (0.719) | |
| CV% | (0.50, 4.05) | 53.8 | 42.7 | 42.7 | 87.8 | 22.0 | 63.6 |
NC=not calculated.
a
Median (min, max).
b
tau=AUC0-24 h (Day1), AUC0-24 h (Day 28).
c
Racc AUCtau=AUCtau Day 28/AUCtau Day1.
d
Ratio Cmax=Cmax Day 28/Cmax Day 1.