Table 1.
Y2157299 proposed dose-escalation scheme for clinical study
| Dose level | Total daily dose (mg day−1) | % increase | Predicted median AUC (20th – 80th percentile range) (mg l−1 h) |
|---|---|---|---|
| 1 | 40 | – | 0.93 (0.76–1.22) |
| 2 | 80 | 100 | 1.86 (1.51–2.44) |
| 3 | 160 | 100 | 3.73 (3.03–4.87) |
| 4 | 240 | 50 | 5.59 (4.54–7.31) |
| 5 | 360 | 50 | 8.38 (6.81–10.96) |
The dose levels in bold are doses that will be administered intermittently (2 weeks on/2 weeks off) based on study protocol amendment. Dose levels 1 and 2 were administered prior to amendment. AUC, area under the plasma concentration vs. time curve.