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NCT03606538 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Resilient Pharmaceuticals.

Not yet
Registry status
Phase 1
Development phase
16
Enrollment target

NCT03606538: Clinical Trial Phase 1 study, sponsored by Resilient Pharmaceuticals.

NCT03606538 is a Phase 1 study that has not yet begun recruiting, run by Resilient Pharmaceuticals. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03606538, a Phase 1 study, has not yet begun recruiting, sponsored by Resilient Pharmaceuticals.

NOT YET RECRUITING
Registry status
Phase 1
Development phase
16 participants
Enrollment target

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.

Interventions

  • DRUG Midomafetamine HCl

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2026-03-29
Est. Completion 2028-12
Phase Phase 1

Sponsor

Resilient Pharmaceuticals

17 total trials

What the Registry Record Tells You About NCT03606538

The ClinicalTrials.gov registry entry for NCT03606538 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Resilient Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Midomafetamine HCl is the first listed.

NCT03606538 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03606538 about?

NCT03606538 is a clinical study titled "MDMA in Subjects With Moderate Hepatic Impairment and 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 fun...

What is the current status of trial NCT03606538?

This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2026-03-29. Estimated completion is 2028-12.

What interventions are being tested in trial NCT03606538?

The interventions under investigation include: Midomafetamine HCl (DRUG).

Who is sponsoring clinical trial NCT03606538?

This trial is sponsored by Resilient Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.