Toxicity screening after repeated dose of a newly developed oral heparin derivative in male cynomolgus monkeys.
Toxicity screening of a newly developed oral heparin derivative was carried out in twelve male cynomolgus monkeys (Macaca fascicularis), composed of three treatment and vehicle control groups. A newly orally active heparin derivative, developed by Seoul National University, was given to the treatment group at three doses with low (12.8 mg/kg), medium (89.6 mg/kg) and high (640 mg/kg) doses for 14 days. A treatment group did not show any change in body weights, hematological parameters (e.g., RBC, WBC, platelet, PDW, MPV, etc.) and serum biochemical parameters (e.g., AST, ALT, BUN, etc.) for 2 weeks compared with those of the vehicle control group. These findings indicated that the oral anticoagulant drug, a newly developed oral heparin derivative, did not have any toxic effect for 2 week in this study. The present study will be valuable in the proper interpretation for non-clinical study using cynomolgus monkeys in the development of a new drug of heparin derivative.
Kim
Choong-Yong
CY
Kim
JeeEun
J
Han
KangHyun
K
Kim
SangKyoon
S
Park
KuiLea
K
Byun
Youngro
Y
D000284:Administration, Oral; D000818:Animals; D000925:Anticoagulants / Q000737:chemistry / Q000633:toxicity*; D003840:Deoxycholic Acid / Q000031:analogs & derivatives* / Q000737:chemistry / Q000633:toxicity; D004334:Drug Administration Schedule; D006495:Heparin, Low-Molecular-Weight / Q000031:analogs & derivatives* / Q000737:chemistry / Q000633:toxicity; D008252:Macaca fascicularis; D008297:Male; D015394:Molecular Structure; D018675:Toxicity Tests
D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; C521279:LMWH-DOCA conjugate; D003840:Deoxycholic Acid