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

NCT03606538 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-10-30

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics
  • Hepatic Impairment

Interventions

DRUG

Midomafetamine HCl

80 mg midomafetamine HCl

Sponsors & Collaborators

Principal Investigators

  • Janel Long-Boyle, PharmD, PhD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-29
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03606538 on ClinicalTrials.gov