A Phase I, Open Label, Study of 3,4-Methylenedioxymethamphetamine (MDMA) Tolerability and Pharmacokinetics in Subjects With Moderate Hepatic Impairment Compared to Matched Control Subjects With Normal Hepatic Function
Resilient Pharmaceuticals
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.
Description
This protocol is for a Phase 1, open-label study with a primary purpose of evaluating the effect of moderate hepatic impairment in the pharmacokinetics of MDMA and its active metabolite, 3,4-methylene-dioxyamphetamine (MDA), and determining whether an adjustment to the dosage would be indicated in this group of patients in comparison to patients with normal liver function. Because people with moderate hepatic impairment may experience greater exposure to drug than people without it, the secondary purpose of this study is to evaluate the effect of moderate hepatic impairment on the safety and t…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 wi…
Interventions
- DrugMidomafetamine HCl
80 mg midomafetamine HCl
Location
- Alliance for Multispecialty Research, LLC.Knoxville, Tennessee