MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function
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
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
Treatments tested in this trial
- Midomafetamine HCl
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov