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. Author manuscript; available in PMC: 2020 Jul 1.
Published in final edited form as: Mol Pharm. 2019 May 30;16(7):3024–3039. doi: 10.1021/acs.molpharmaceut.9b00263

Table 3.

Toxicity Assessment of FAF–Rapa via Serum Chemistry and Organ/Body Weight Measurements (Mean ± SD)

category parameters vehicle free Rapa carrier (FAF) FAF-Rapa
serum chemistry (n = 13) ALT (IU/L)a 34.1 ± 20.8 82.3 ± 97.4 49.0 ± 43.2 158.3 ± 225.6
ALP (IU/L) 43.1 ± 5.7 45.0 ± 9.5 34.7 ± 9.3 48.0 ± 9.6
BUN (mg/dL) 23.6 ± 2.2 22.1 ± 2.6 23.3 ± 3.0 22.5 ± 2.1
creatinine (mg/dL) 0.2 ± 0.00 0.2 ± 0.00 0.2 ± 0.00 0.2 ± 0.04
BUN/creatinine ratio 118.2 ± 11.2 110.4 ± 12.8 116.5 ± 14.9 106.8 ± 16.6
organ weights (n = 15) lung (% BW) 0.60 ± 0.07 0.63 ± 0.06 0.57 ± 0.07 0.63 ± 0.09
liver (% BW) 4.7 ± 0.5 4.9 ± 0.4 4.5 ± 0.4 5.0 ± 0.5
spleen (% BW) 0.29 ± 0.05 0.28 ± 0.09 0.33 ± 0.06 0.28 ± 0.09
kidney (% BW) 1.6 ± 0.1 1.6 ± 0.1 1.5 ± 0.2 1.6 ± 0.1
body weight change (% BW)b 1.5 ± 2.9 1.7 ± 2.7 3.3 ± 2.3 −1.8 ± 3.2
a

Two-way ANOVA showed a statistically significantly different ALT level from Rapa treatment (Vehicle + FAF vs free Rapa + FAF–Rapa, p = 0.03) but no significant interaction between Rapa and FAF (p = 0.4). No statistical significance was achieved among groups using the Kruskal–Wallis nonparametric test.

b

Kruskal–Wallis nonparametric test was performed for body weight change (n = 15) based on a statistical significance achieved by Rapa treatment (Vehicle + FAF vs free Rapa + FAF–Rapa, p = 0.001) and significant interaction between Rapa and FAF (p < 0.001) using two-way ANOVA. From Kruskal–Wallis nonparametric test, the body weight change of FAF–Rapa-treated group was statistically significantly different compared to vehicle (p = 0.012), free Rapa (p = 0.006), and carrier (p < 0.001).