MDMA pharmacokinetics: A population and physiologically based pharmacokinetics model-informed analysis.

ABSTRACT: Midomafetamine (3,4-methylenedioxymethamphetamine [MDMA]) is under the U.S. Food and Drug Administration review for treatment of post-traumatic stress disorder in adults. MDMA is metabolized by CYP2D6 and is a strong inhibitor of CYP2D6, as well as a weak inhibitor of renal transporters MATE1, OCT1, and OCT2. A pharmacokinetic phase I study was conducted to evaluate the effects of food on MDMA pharmacokinetics. The results of this study, previously published pharmacokinetic data, and in vitro data were combined to develop and verify MDMA population pharmacokinetic and physiologically based pharmacokinetic models. The food effect study demonstrated that a high-fat/high-calorie meal did not alter MDMA plasma concentrations, but delayed T_max. The population pharmacokinetic model di

SUBMITTER: Huestis MA 

PROVIDER: S-EPMC11812931 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature