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

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
Resilient Pharmaceuticals
Study ID
NCT03606538
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Hepatic Impairment
  • Pharmacokinetics

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Midomafetamine HCl — DRUG
    80 mg midomafetamine HCl

Study Details

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.

Key Dates

Start date
Mar 29, 2026
Status verified
Oct 2024
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
16 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Moderate hepatic impairment
    Eight participants with moderate hepatic impairment receive a single dose of 80 mg midomafetamine HCl.
  • Experimental: Normal hepatic function
    Eight participants, each matched on age, weight and gender to a participant with moderate hepatic impairment, receive a single dose of 80 mg midomafetamine HCl.

Primary Outcome Measure

Area under curve from dosing time to last measurement (AUC(0-t)) - MDMA [ Time Frame: 0 to 5 days after drug administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Alliance for Multispecialty Research, LLC.KnoxvilleTennessee37920
Study coordinator

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Alliance for Multispecialty Research, LLC.· Knoxville, TN

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