INTRODUCTION: Remlifanserin, or ACP-204, is a potent serotonin 2A receptor inverse agonist under investigation for treatment of Alzheimer's disease psychosis and Lewy body dementia psychosis. A population pharmacokinetics (popPK) model for remlifanserin was developed to evaluate the impact of covariates affecting pharmacokinetic variability and assess the clinical relevance of these factors in a virtual population. METHODS: = 1000; 60 mg/day) were derived using PK parameters sampled from the final model. The clinical relevance of significant covariates was evaluated using geometric mean ratios and 90% confidence intervals (CIs) of exposures using a 0.8 to 1.25 boundary presented in a forest plot. RESULTS: . DISCUSSION: The pharmacokinetics of oral remlifanserin (10 to 180 mg) are well described by dose-proportional linear kinetics. No intrinsic or extrinsic factors exhibited a clinically relevant effect on steady-state remlifanserin exposures.
Darwish et al. (Wed,) studied this question.