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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Computed exposure to MDMA using blood collected periodically at 1, 2, 4, 6, 7, 10, 12, 24, 36, 48, 72 and 96 h post drug
Interventions
- DRUG Midomafetamine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2026-03-29 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What is known before NCT03606538 opens enrollment
NCT03606538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Midomafetamine HCl is the first listed.
NCT03606538 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03606538's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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