Table 4.
Species | Study | Dose/s | Group sex and size | Findings |
---|---|---|---|---|
Sprague Dawley rat | 8 week GLP toxicology | 0 mg/kg (iv) | 10M+10F/group and 5M+5F recovery/group and 6M+6F TK satellites/group | Liver findings: Hepatic centrilobular to bridging sinusoidal dilation |
1 mg/kg (iv) | Decreased red blood cells (monitorable) | |||
3 mg/kg (iv) | Proliferative vascular neoplasms | |||
10 mg/kg (iv) | – Skin, lung, and heart lesions seen only in rats | |||
30 mg/kg (iv) | ||||
Cynomolgus monkey | 8 week GLP toxicology with 12 week recovery | 0 mg/kg (iv) | 3M+3F/group and 2M+2F recovery/group and 2M+2F for telemetry on the control and high dose group | Liver findings: Hepatic centrilobular to bridging sinusoidal dilation |
0.2 mg/kg (iv) | Decreased red blood cells (monitorable) | |||
0.8 mg/kg (iv) | ||||
3 mg/kg (iv) | ||||
12 mg/kg (iv) |