Clinical TrialHealthy VolunteersMDMAMDMANot yet recruiting

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

Open-label Phase 1 parallel PK study (n=16; 8 moderate hepatic impairment, 8 matched controls) assessing single oral 80 mg MDMA to determine effects of hepatic impairment on MDMA/MDA exposure and need for dose adjustment.

Target Enrollment
16 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Phase 1, open-label, parallel-group pharmacokinetic study comparing a single oral 80 mg dose of MDMA in participants with moderate hepatic impairment and matched healthy controls; intensive plasma sampling on Day 1 and additional samples on subsequent days to calculate AUC, Cmax and Tmax.

Safety and tolerability assessed via vitals, serial 12-lead ECGs, adverse events and C-SSRS; participants remain in clinic for three days with follow-ups on days 8 and 15.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Moderate hepatic impairment

experimental

Eight participants with moderate hepatic impairment receive a single oral 80 mg dose of midomafetamine HCl (MDMA HCl).

Interventions

  • MDMA80 mg
    via Oral• single dose• 1 doses total

    Midomafetamine HCl (MDMA HCl) 80 mg

Normal hepatic function

experimental

Eight matched healthy participants receive a single oral 80 mg dose of midomafetamine HCl (MDMA HCl).

Interventions

  • MDMA80 mg
    via Oral• single dose• 1 doses total

    Midomafetamine HCl (MDMA HCl) 80 mg

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment16 participants
  • Timeline
    Start: 2022-03-29
    End: 2023-12-01
  • Compounds
    MDMAMDMA
  • Topic
    Healthy Volunteers

Locations

Alliance for Multispecialty Research, LLC. — Knoxville, Tennessee, United States

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