Forty five male and 45 female rats were assigned randomly to treatment with either 0, 0.00625, or 0.01250 mg/kg of an investigational drug (15 rats of each sex/treatment group). Intravenous dosing by trial injection was performed once daily for a period of five consecutive weeks. At sacrifice, total body weight was recorded, and during the necropsy, the weights of several organs including the brain and the thymus were also recorded.
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| Part 3 - Table 1 | |||||||||||||||||
| Organ Weight Study in Rats | |||||||||||||||||
| Dose | Animal | ||||||||||||||||
| Sex | Organ | (mg/kg) | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 |
| M | Body | 0 | 331 | 361 | 380 | 371 | 378 | 381 | 355 | 296 | 341 | 382 | 404 | 378 | 361 | 367 | 343 |
| Weight | 0.00625 | 311 | 360 | 375 | 366 | 317 | 358 | 352 | 364 | 338 | 362 | 422 | 345 | 304 | 371 | 404 | |
| (gm) | 0.01250 | 361 | 322 | 293 | 372 | 360 | 385 | 319 | 384 | 350 | 335 | 374 | 284 | 306 | 372 | 432 | |
| Brain | 0 | 1.86 | 1.91 | 2.03 | 1.92 | 2.06 | 1.88 | 2.02 | 1.98 | 1.97 | 1.99 | 2.00 | 2.06 | 2.00 | 1.97 | 1.92 | |
| (gm) | 0.00625 | 1.82 | 1.89 | 1.93 | 1.98 | 1.89 | 1.82 | 1.96 | 1.91 | 1.90 | 1.97 | 2.13 | 2.05 | 2.05 | 1.98 | 1.88 | |
| 0.01250 | 2.10 | 2.01 | 1.96 | 1.94 | 1.96 | 1.93 | 1.95 | 1.95 | 2.01 | 1.96 | 2.02 | 1.81 | 1.94 | 2.02 | 1.98 | ||
| Thymus | 0 | 0.49 | 0.66 | 0.86 | 0.61 | 0.51 | 0.43 | 0.57 | 0.44 | 0.40 | 0.74 | 0.56 | 0.46 | 0.40 | 0.44 | 0.47 | |
| (gm) | 0.00625 | 0.56 | 0.68 | 0.44 | 0.41 | 0.43 | 0.47 | 0.73 | 0.57 | 0.44 | 0.49 | 0.73 | 0.61 | 0.40 | 0.63 | 0.64 | |
| 0.01250 | 0.70 | 0.39 | 0.40 | 0.69 | 0.57 | 0.69 | 0.48 | 0.86 | 0.66 | 0.55 | 0.37 | 0.55 | 0.38 | 0.63 | 0.86 | ||
| F | Body | 0 | 214 | 218 | 222 | 215 | 238 | 224 | 212 | 237 | 215 | 271 | 196 | 181 | 229 | 231 | 255 |
| Weight | 0.00625 | 228 | 209 | 242 | 228 | 200 | 219 | 228 | 197 | 208 | 198 | 199 | 190 | 233 | 199 | 205 | |
| (gm) | 0.01250 | NM | 198 | 171 | 222 | 133 | 182 | 211 | 207 | 184 | 215 | 188 | 186 | 226 | 223 | 242 | |
| Brain | 0 | 1.85 | 1.93 | 1.94 | 1.73 | 1.83 | 2.07 | 1.90 | 1.91 | 1.73 | 1.99 | 1.80 | 1.81 | 1.83 | 2.01 | 1.89 | |
| (gm) | 0.00625 | 1.93 | 1.83 | 1.94 | 1.74 | 1.76 | 1.81 | 1.81 | 1.85 | 1.71 | 1.73 | 1.79 | 1.80 | 1.94 | 1.89 | 1.89 | |
| 0.01250 | 1.72 | 1.76 | 1.72 | 1.70 | 1.87 | 1.72 | 1.88 | 1.98 | 1.83 | 1.82 | 1.67 | 1.85 | 1.82 | 1.92 | 1.75 | ||
| Thymus | 0 | 0.44 | 0.50 | 0.59 | 0.49 | 0.71 | 0.56 | 0.50 | 0.77 | 0.50 | 0.60 | 0.44 | 0.46 | 0.52 | 0.64 | 0.67 | |
| (gm) | 0.00625 | 0.54 | 0.36 | 0.45 | 0.48 | 0.37 | 0.36 | 0.40 | 0.42 | 0.50 | 0.32 | 0.38 | 0.48 | 0.49 | 0.29 | 0.44 | |
| 0.01250 | 0.38 | 0.40 | 0.29 | 0.54 | 0.48 | 0.36 | 0.57 | 0.29 | 0.30 | 0.44 | 0.26 | 0.45 | 0.42 | 0.52 | 0.66 | ||
NM - Not Measured