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MDMA in People with Liver Impairment

This study is looking at how the body processes MDMA (Midomafetamine HCl) in people with moderate liver problems compared to those with normal liver function. Researchers want to understand if people with liver impairment absorb more MDMA and if their dose needs to be adjusted. Sixteen participants, aged 18 to 65, will be enrolled. This includes eight people with moderate liver impairment and eight people with normal liver function. Everyone will receive a single dose of MDMA. The main goal is to measure how much MDMA and its active breakdown product, MDA, are in the body over 5 days. The study is currently unclear on its recruitment status.

Study design
This is a Phase 1, open-label study involving 16 participants. It compares how MDMA affects people with moderate liver impairment to those with normal liver function.
What's involved
You would undergo a screening process, including a physical exam and blood tests. After receiving a single dose of MDMA, you would stay at the study site for two more days for vital sign measurements and to report any side effects.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure drug levels for up to 5 days after you receive the MDMA dose.

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NCT03606538

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

Not Yet Recruiting
PHASE1Ages 18–65InterventionalBasic science
Resilient Pharmaceuticals
~16 participants
Updated 2024-10-30 on ClinicalTrials.gov
What's tested:Midomafetamine HCl

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area under curve from dosing time to last measurement (AUC(0-t)) - MDMA
Measured over 0 to 5 days after drug administration
+1 more outcome measured

Conditions

Pharmacokinetics
Hepatic Impairment

Explore related trials

Liver Failure

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

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

Who to contact

Recruitment Officer
[email protected]
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Area under curve from dosing time to last measurement (AUC(0-t)) - MDMA0 to 5 days after drug administration

    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

  • Area under curve from dosing time to last measurement (AUC(0-t) MDA0 to 5 days after drug administration

    Computed exposure to MDA using blood collected periodically at 1, 2, 4, 6, 7, 10, 12, 24, 36, 48, 72 and 96 h post-MDMA administration