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

ConditionsPharmacokinetics Hepatic Impairment

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorResilient Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Midomafetamine HCl
Drug
80 mg midomafetamine HCl

Treatment groups

16 Participants

are divided into 2 treatment groups

Group A: Moderate hepatic impairmentExperimental treatment 1 intervention

Group B: Normal hepatic functionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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

Time frame