MDMA is under FDA review as a treatment for PTSD in adults. This modeling-informed analysis, supported by AMR Clinical sites, evaluated its pharmacokinetics under various conditions including fed vs. fasted states, single vs. split dosing, and drug–drug interactions. The study found no meaningful food effect, confirmed MDMA’s role as a strong CYP2D6 inhibitor, and used PopPK and PBPK modeling to predict exposure across clinical dosing scenarios.
Read this publication to explore:
- Food effects and dose timing impact on MDMA exposure
- Insights into MDMA’s inhibition of CYP2D6
- Model-based predictions of clinical pharmacokinetics