Extended Table 3a.
Summary of serum concentrations of 2141-V11 in cycle 1 (ng/mL)
| Cycle/Day | Timepoint | Statistics | Dose 1 0.7 mg (n=3) |
Dose 2 2.0 mg (n=3) |
Dose 3 7.0 mg (n=3) |
Dose 4 10.0 mg (n=3) |
|---|---|---|---|---|---|---|
| Cycle 1 - Day 1 | Predose | n | 3 | 3 | 3 | 3 |
| Mean | 0.000 | 0.000 | 0.000 | 0.000 | ||
| SD | 0.000 | 0.000 | 0.000 | 0.000 | ||
| Median | 0.000 | 0.000 | 0.000 | 0.000 | ||
| Min | 0.000 | 0.000 | 0.000 | 0.000 | ||
| Max | 0.000 | 0.000 | 0.000 | 0.000 | ||
| CV% | NC | NC | NC | NC | ||
|
| ||||||
| 15 minutes | n | 3 | 3 | 3 | 3 | |
| Mean | 0.000 | 0.000 | 45.400 | 564.600 | ||
| SD | 0.000 | 0.000 | 78.640 | 611.800 | ||
| Median | 0.000 | 0.000 | 0.000 | 362.200 | ||
| Min | 0.000 | 0.000 | 0.000 | 79.660 | ||
| Max | 0.000 | 0.000 | 136.200 | 1252.000 | ||
| CV% | NC | NC | 173.2 | 108.4 | ||
|
| ||||||
| 2 hour | n | 3 | 3 | 3 | 3 | |
| Mean | 0.000 | 0.000 | 48.900 | 286.400 | ||
| SD | 0.000 | 0.000 | 84.700 | 323.400 | ||
| Median | 0.000 | 0.000 | 0.000 | 142.200 | ||
| Min | 0.000 | 0.000 | 0.000 | 60.070 | ||
| Max | 0.000 | 0.000 | 146.700 | 656.800 | ||
| CV% | NC | NC | 173.2 | 112.9 | ||
|
| ||||||
| 6 hour | n | 3 | 3 | 3 | 3 | |
| Mean | 0.000 | 0.000 | 41.53 | 93.53 | ||
| SD | 0.000 | 0.000 | 71.94 | 162 | ||
| Median | 0.000 | 0.000 | 0.000 | 0.000 | ||
| Min | 0.000 | 0.000 | 0.000 | 0.000 | ||
| Max | 0.000 | 0.000 | 124.6 | 280.6 | ||
| CV% | NC | NC | 173.2 | 173.2 | ||
|
| ||||||
| 24 hour | n | 3 | 3 | 3 | 3 | |
| Mean | 0.000 | 0.000 | 0.000 | 0.000 | ||
|
| ||||||
| Cycle 1 - Day 4 | 96 hour | n | 2 | 3 | 3 | 3 |
| Mean | 0.000 | 0.000 | 0.000 | 0.000 | ||
|
| ||||||
| Cycle 1 - Day 8 | 192 Hour | n | 2 | 3 | 3 | 3 |
| Mean | 0.000 | 0.000 | 0.000 | 0.000 | ||
|
| ||||||
| Cycle 1 - Day 15 | 360 Hour | n | 2 | 3 | 3 | 3 |
| Mean | 0.000 | 0.000 | 0.000 | 0.000 | ||
CV% = Coefficient of variation; Min = Minimum; Max = Maximum; SD = Standard Deviation; NC = Not Calculable. n = number of PK evaluable patients