Table 2.
Study design of the 30-day GLP toxicity study in Göttingen minipigs with a 14-day recovery period.
| Group | Dose SUL-138 (mg/kg/day) |
N (M/F) |
||
|---|---|---|---|---|
| Free base | Main | Recovery | ||
| 1 | Vehicle | 3/3 | 2/2 | |
| 2 | 16 | 3/3 | ||
| 3 | 82 | 3/3 | ||
| 4 | 409 | 3/3 | 2/2 | |
| Evaluations | Interval | |||
| Clinical observations | Once daily | |||
| Body weight | Weekly | |||
| Food intake | Daily | |||
| Body temperature | Day 1 and Day 29 at predose, 1, 4 and 8 hours | |||
| Ophthalmoscopy | Before start treatment and at day 29 | |||
| Electrocardiography | Before start treatment, day 1 and day 29 at predose and 2 hours post dose | |||
| Clinical pathology and urinanalysis | Before start treatment, end of treatment and end of recovery | |||
| Toxicokinetics | Day 1: 0.13, 0.25, 0.5, 1, 2, 4, 8 and 24 hours post dose Day 29: predose, 0.13, 0.25, 0.5, 1, 2, 4, 8 and 24 hours post dose (n: 3 per sex/dosing group) |
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