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

NCT03606538 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: MPKH
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacokinetics; Hepatic Impairment

Keywords

MDMA; metabolism; methylenedioxymethamphetamine; midomafetamine

Outcome Measures

Primary Outcomes (2)

• 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

  0 to 5 days after drug administration

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

  Computed exposure to MDA using blood collected periodically at 1, 2, 4, 6, 7, 10, 12, 24, 36, 48, 72 and 96 h post-MDMA administration

  0 to 5 days after drug administration

Secondary Outcomes (31)

• Peak MDMA (Cmax)

  0 to 5 days after drug administration

• Peak MDA (Cmax)

  0 to 5 days after drug administration

• Time to maximum (Tmax) MDMA

  0 to 5 days after drug administration

• Time to maximum (Tmax) MDA

  0 to 5 days after drug administration

• Area under curve from dosing time to infinity (AUC(0-infinity)) - MDMA

  0 to 5 days after drug administration

Study Arms (2)

Moderate hepatic impairment

EXPERIMENTAL

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

Drug: Midomafetamine HCl

Normal hepatic function

EXPERIMENTAL

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.

Drug: Midomafetamine HCl

Interventions

Midomafetamine HCl DRUG

80 mg midomafetamine HCl

Also known as: MDMA, 3,4-methylenedioxymethamphetamine, midomafetamine, MDMA HCl

Moderate hepatic impairment; Normal hepatic function

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lykos Therapeutics: lead

Study Sites (1)

Alliance for Multispecialty Research, LLC.

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Janel Long-Boyle, PharmD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Recruitment Officer

CONTACT

recruitment@lykospbc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking; open-label
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Matched group comparison of pharmacokinetics and metabolism of single dose of 80 mg MDMA in participants with moderate hepatic impairment and participants with normal hepatic function and matched on age, weight and gender.

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 31, 2018
• Study Start: March 29, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data and study-related documents will be available when all participants have completed the study
• Access Criteria: Interested persons should correspond with the central contact for the multisite study.

Locations

US (1)