TABLE 1

Percentage of dose recovered following administration of a single p.o. or i.v. dose of [14C]dasatinib to rats and monkeys


Species

Route/Dose

Collection Interval

Percentage of Dose Recovered
Urine
Bile
Feces
Cage Debris/Wash
Total
h mean ± S.D. mean ± S.D. mean ± S.D. mean ± S.D. mean ± S.D.
Intact Rat (n = 3) p.o. 15 mg/kg 0–168 6.45 ± 0.82 N.A. 76.39 ± 8.45 6.70 ± 4.88 89.54 ± 4.73
BDC Rata (n = 2) p.o. 10 mg/kg 0–12 3.2 (2.7, 3.6) 35.8 (32.5, 39.1) N.C. N.C. 39.0b (35.2, 42.7)
BDC Rata (n = 2) i.v. 10 mg/kg 0–12 12.0 (14.9, 9.1) 67.4 (61.2, 73.6) N.C. N.C. 79.4 (76.1, 82.7)
Intact monkey (n = 3) p.o. 10 mg/kg 0–168 2.99 ± 1.55 N.A. 76.82 ± 9.75 8.84 ± 8.62 88.65 ± 2.42
BDC monkey (n = 3)
i.v. 2 mg/kg
0–72
9.89 ± 2.88
67.24 ± 16.40
13.67 ± 12.66
N.C.
90.80 ± 2.56
  • N.A., not applicable; N.C., not collected

  • a The BDC rat study was not run as a comprehensive mass-balance study; samples were only collected over a 12-h period. Because there were only two animals per treatment group, the S.D. was not reported. The mean and individual recoveries for each animal were reported

  • b An additional 61.2 (Rat 1) and 44.7% (Rat 2) of the radioactive dose was recovered in the GI tract of p.o.-dosed animals at the end of the study (12 h after drug administration), bringing the mean total recovery of radioactivity to 92.0%