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Pharmacokinetic evaluation of CJ‐11555, a novel anti‐cirrhotic agent in rats

CJ‐11555 has been demonstrated to increase the survival rates of cirrhotic rats as a result of regeneration of the liver and improvement in its function. Therefore, CJ‐11555 is to be investigated for its potential as a therapeutic agent that regenerates cirrhotic liver cell. In this study, the pharmacokinetic behaviors were evaluated after single oral dosing in different vehicles; with and without food; in normal and disease model; and following 14‐day‐coadministration of CJ‐11555 with either silymarin or ursodeoxycholic acid (UDCA) using rat. In the groups that orally dosed CJ‐11555 in different vehicles, saline, 40% PEG, and olive oil, Cmax appeared to be 0.3, 0.65, and 1.3 μg/mL at 6, 6, and 2 hrs under the fasted condition, respectively; immediate and higher absorption was observed in olive vehicle group by 3‐fold in Cmax and by 1.5‐fold in AUC as compared to saline vehicle group. Systemic exposure was rapidly increased by food consumption upto 163%, although systemic availability was decreased by 37%. Severe liver damaged model, bile duct‐ligated rats showed significant increases in Cmax (0.92 ± 0.15 vs 0.50 ± 0.05 μg/mL at 9.3 ± 1.3 vs 5.5 ± 0.5 hr) and AUC (26.9 ± 5.7 vs 4.4 ± 0.2 μg.hr/mL) as compared to normal rats. Concomitant administration of CJ‐11555 with either silymarin or UDCA did not significantly affect the pharmacokinetic parameters. This study extends our understanding of CJ‐11555 in clinic use that the agent can be assessed with food consumption, necessity of dose adjustment in patients with very severe liver cirrhosis and combination with either silymarin or UDCA.