TABLE 1.
Noncompartmental PK parameters of elvucitabine in plasma on day 1 (eight subjects per cohort)a
| Parameter | Valuesa for dose of:
|
P valueb | ||
|---|---|---|---|---|
| 5 mg | 10 mg | 20 mg | ||
| AUC0-24 (ng·h/ml) | 59.9 (39.3),* 49.9 (26.1-88.1) | 155 (41.0),* 130 (85.6-236) | 262 (40.4), 229 (161-492) | NS*** |
| Cmax (ng/ml) | 7.25 (57.6), 6.69 (1.37-13.2) | 25.3 (50.7), 22.0 (2.45-40.0) | 39.1 (38.5), 37.2 (21.7-67.7) | NS*** |
| Tmax (h) | 6.63 (54.7), 4.00 (4.00-11.0) | 3.31 (55.3), 3.00 (1.50-7.00) | 3.75 (18.9), 4.00 (2.00-4.00) | <0.05** |
| C24 (ng/ml) | 0.832 (34.2),* 0.809 (0.521-1.42) | 1.87 (48.9),* 1.36 (1.05-3.30) | 3.41 (35.9), 3.42 (1.81-5.70) | NS*** |
a
Values for the dosing regimen are as follows: arithmetic mean (%CV), median (range). *, one subject from the 5-mg dose cohort and one from the 10-mg dose cohort were excluded since concentration was below the limit of quantitation by 24 h postdose (total of seven subjects per cohort).
b
**, 10-mg and 20-mg dose cohorts are not statistically significantly different from each other; ***, analysis of variance performed using dose-normalized parameters; NS, not statistically significant (P > 0.05).