A Phase I, Open Label, Study of 3,4-Methylenedioxymethamphetamine (MDMA) Tolerability and Pharmacokinetics in Subjects With Moderate Hepatic Impairment Compared to Matched Control Subjects With Normal Hepatic Function
The goal of this clinical trial to learn how MDMA is processed in people with abnormal liver function. The main questions it aims to answer are: Do people with abnormal liver function experience greater absorption of MDMA? Does the dose of MDMA need to be adjusted in people with abnormal liver function? Researchers will compare people with abnormal liver function to people with normal liver function. Participants will receive a single dose of MDMA then undergo periodic vitals measurements. They will remain at the study site for two more days undergoing more vitals measurements and having subjective effects and adverse events measured.
- Status
- planned
- Phase
- Phase 1
- Institution
- Resilient Pharmaceuticals
- Principal investigator
- Janel Long-Boyle, PharmD, PhD
- Start date
- 2026-03-29
- End date
- 2028-12-01
- Registry ID
- NCT03606538
Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.