Table 4.
Urine Carboxypirfenidone Ae0–24 (mg)
| Cohort 1 |
Cohort 2 |
Cohort 3 |
Cohort 4 |
Cohort 5 |
Cohort 6 |
|
|---|---|---|---|---|---|---|
| Active |
Active |
Active |
Active |
Active |
Active |
|
| 25 mg |
50 mg |
100 mg |
100 mg |
100 mg |
100 mg |
|
| (N = 6) | (N = 5)a | (N = 6) | (N = 6) | (N = 6) | (N = 6) | |
| Mean (SD) | 10.4 (5.5) | 11.2 (8.5) | 49.0 (22.7) | 40.3 (21.5) | 46.7 (5.3) | 42.2 (14.8) |
| CV% | 53.1 | 75.9 | 46.2 | 53.4 | 11.4 | 35.0 |
| Median | 10.2 | 10.2 | 56.3 | 47.3 | 47.3 | 45.3 |
| Minimum, Maximum | 4.2, 19.2 | 2.3, 24.9 | 3.6, 64.0 | 14.0, 64.6 | 39.5, 55.1 | 18.8, 59.3 |
| Geometric mean | 9.2 | 8.6 | 36.4 | 34.0 | 46.5 | 39.6 |
| CV% geometric mean | 61.3 | 106.9 | 164.0 | 78.2 | 11.4 | 44.1 |
Ae0–24 urine excretion of four sequential 6-hour collections.
a
One subject's dose was splashed out of device (unknown amount lost) so PK data unevaluable.