drugset / Trial / NCT03606538

MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function

NCT03606538

Phase 1 Not yet recruiting 16 enrolled Resilient Pharmaceuticals
Non-randomizedParallel-groupOpen-labelBasic science

Summary

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.

Timeline

Start
2026-03-29
Primary completion
2028-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Midomafetamine Unknown 80 mg Oral

Indications

No indication recorded.