Phase I Studies of Acebilustat: Pharmacokinetics, Pharmacodynamics, Food Effect, and CYP3A Induction.

ABSTRACT: Acebilustat is a new once-daily oral antiinflammatory drug in development for treatment of cystic fibrosis (CF) and other diseases. It is an inhibitor of leukotriene A4 hydrolase; therefore, production of leukotriene B4 (LTB4) in biological fluids provides a direct measure of the pharmacodynamic (PD) response to acebilustat treatment. Here we compare the pharmacokinetics (PK) and PD between CF patients and healthy volunteers, and investigate the food effect and CYP3A4 induction in healthy volunteers. No significant differences between study populations were observed for peak plasma level (C_max ) or exposure (AUC). In healthy volunteers, a shift in time to C_max (T_max ) was observed after a high-fat meal, but there was no change in AUC. LTB4 production was re

SUBMITTER: Elborn JS 

PROVIDER: S-EPMC5351008 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature