Summary of Demographics, TRAE and PK Parameters
| Cohort | 1 | 2 | 3 | 4 | 5 |
|---|---|---|---|---|---|
| Total Daily Dose (mg) | 30 | 60 | 105 | 150 | 195 |
| Patients (N) | 3 | 4 | 4 | 3 | 3 |
| Median age (Range) | 54 (48–56) | 61 (46–78) | 70 (52–77) | 72 (56–72) | 65 (37–75) |
| Male/Female | 0/3 | 2/2 | 1/3 | 1/2 | 1/2 |
| TRAE, n (Grade) | 0 | 3 (G2) | 2 (G2) | 1 (G2) | 6 (G2) |
| Mean of PK Parameters | |||||
| tmax (h) | 1 | 0.7 | 1.6 | 1.2 | |
| Cmax (ng/mL) | 95 | 162 | 374 | 781 | 1875 |
| AUClast (ng·h/mL) | 200 | 257 | 819 | 1854 | 3664 |
| t1/2 (h) | 2.1 | 1.7 | 1.7 | 2.6 | |
| * For cohort 5, simulated data | |||||