Clinical Trial

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

Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 25 amendments
This ClinicalTrials.gov record has been amended 25 times since 2018-07-20; most recent amendment 2024-10-28.
Status change: Recruiting → Not Yet Recruiting 2021-05-21
Status change: Not Yet Recruiting → Recruiting 2020-02-18
Trial Details
NCT Number NCT03606538
Lead Sponsor Resilient Pharmaceuticals
Conditions Pharmacokinetics, Hepatic Impairment
Enrollment 16 participants
Start Date 2026-03-29
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2024-10-30