Table 7.
Relevant FOB findings in rats during Week 5 (4-6 hours post-dose)
| Parameter | 0 mg/kg | 10 mg/kg | 40 mg/kg | 150 mg/kg | ||||
|---|---|---|---|---|---|---|---|---|
| M (N=10) |
F (N=7) |
M (N=10) |
F (N=10) |
M (N=10) |
F (N=8) |
M (N=9) |
F (N=6) |
|
| AUC (hr*ng/mL) on Day 34 | 0 | 0 | 9720 | 30700 | 10300 | 28600 | 6770 | 20600 |
| Mean plasma concentration (ng/mL) at 4 h post-dose on Day 34 | 0 | 0 | 716 | 1627 | 1237 | 1370 | 560 | 1207 |
| Repetitive groominga | 0 | 0 | 2 | 6 | 4 | 1 | 0 | 0 |
| Head shakingb | 0 | 0 | 0 | 6 | 1 | 1 | 0 | 1 |
| Scratching | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 |
| Slow or no response (approach, touch, tail pinch, or startle) | 0 | 0 | 4 | 1 | 5 | 0 | 1 | 1 |
| Retropulsion | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Reduced palpebral reflex | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
| Mean rectal temperature (°F) ± SD | 100.4±0.4 | 99.5±0.2 | 100.1±0.2 | 100.9*±0.3 | 99.6±0.5 | 100.6*±0.1 | 100.4±0.4 | 100.2*±0.2 |
a
includes excessive / repetitive scratching or shaking of the head, and/or fast grooming
b
With or without repetitive grooming.
*
p<0.05; M: Male; F: Female.
Numbers in the table, except rectal temperature, indicate ‘number of animals with the observation’.