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Not yet recruitingPhase 1

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

NCT03606538 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 1
Phase
16
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Area under curve from dosing time to last measurement (AUC(0-t)) - MDMA

    Measured over 0 to 5 days after drug administration

  • Area under curve from dosing time to last measurement (AUC(0-t) MDA

    Measured over 0 to 5 days after drug administration

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Participants with moderate hepatic impairment (class B according to Child- Pugh's criteria). * Participants with normal hepatic function: no clinically significant findings from medical history, physical examination, laboratory values within protocol defined parameters. * Age 18 to 65 years. * Weight \> 45 kg * Negative Carbohydrate Deficient Transferrin blood test at Screening and negative breathalyzer alcohol test prior to trial drug administration. * Negative urine test for drugs of abuse at Screening and prior to trial drug administration. * Able to comprehend and willing to sign an informed consent form. Exclusion Criteria: * Have a current psychiatric diagnosis. * Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control. * Have acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within 2 weeks. * Have autoimmune liver disease; esophageal variceal bleeding within 6 months prior to screening, unless successfully treated with banding, or gastric varices. * Have spontaneous bacterial peritonitis within 3 months prior to screening. * Have a portosystemic shunt, organ transplant, Wilson's disease, cholestatic liver disease (e g, primary biliary cirrhosis or primary sclerosing cholangitis) * Evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular (including controlled hyper-tension), coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration. * For moderate hepatic impairment participants: have clinically significant laboratory findings except as related to hepatic impairment. * For control participants only: have clinically significant laboratory results outside the normal limits, including AST \>48 U/L, ALT \> 55 U/L, GGT \> 48 U/L, bilirubin \> 1.2 mg/dL or hemoglobin \< 12 g/dL. * Have a history of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. * Have any positive test for drugs of abuse and /or alcohol at screening. * Have a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of \> 450 ms in men, \> 470 ms in women on the screening ECG. * Have a PR interval \> 240 ms, QRS \> 110 ms or a history of prolongation of QT interval. * Have mental incapacity, unwillingness or language barriers precluding adequate understanding or subject co-operation. * Are unwilling to stay in the clinical unit for the required duration as per the protocol. * Have a known or suspected allergy to trial product or related products.

Where

1 study site

FacilityCityRegionCountry
Alliance for Multispecialty Research, LLC.KnoxvilleTennesseeUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03606538 on ClinicalTrials.gov →

Last updated in the registry 2024-10-30. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits