Food Effects on Bioavailability of MDMA in Healthy Volunteers

NCT05147402 | Completed Phase 1 FDA Drug

• 1 other identifier: MPKF
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if food impacts absorption of MDMA in participants who are either fed or fasted. The main question it aims to answer is: What is the effect of eating food on the safety of taking oral MDMA? Researchers will compare participants who are fasted for 10 hours to participants who are fed a high-fat and high-calorie meal. Participants will be randomized to either the fed or fasted group, then be administered MDMA. Vitals and blood samples will be taken. Then, participants will be assigned to the opposite condition and vitals and blood samples will be taken.

Conditions

Pharmacokinetics

Keywords

MDMA; Metabolism; Methylenedioxymethamphetamine; midomafetamine

Outcome Measures

Primary Outcomes (2)

• Area under the curve from dosing time to last measurement - Plasma concentration of MDMA

  Computed exposure to MDMA using blood collected periodically at pre-dose as well as 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 12 hours post drug administration.

  0 to 1 day after drug administration

• Area under the curve from dosing time to last measurement - Plasma concentration of active metabolite MDA

  Computed exposure to MDMA using blood collected periodically at pre-dose as well as 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 12 hours post drug administration

  0 to 1 day after drug administration

Study Arms (2)

Fasted Treatments with 120 mg midomafetamine HCl

ACTIVE COMPARATOR

Following an overnight fast of at least 10 hours, participants will be administered 100 mg midomafetamine (equivalent to 120 mg midomafetamine HCl) with 240 mL of water. No food should be allowed for at least 4 hours post-dose.

Drug: midomafetamine

Fed Treatments with 120 mg midomafetamine HCl

ACTIVE COMPARATOR

A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal will be used as a test meal for food-effect evaluation. Following an overnight fast of at least 10 hours, participants will start the recommended meal 30 minutes prior to administration of the drug product. Participants will eat this entire meal in 30 minutes or less. 100 mg midomafetamine (equivalent to 120 mg midomafetamine HCl) will be administered 30 minutes after start of the meal with 240 mL of water.

Drug: midomafetamine

Interventions

midomafetamine DRUG

100 mg midomafetamine (equivalent to 120 mg midomafetamine HCl).

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

Fasted Treatments with 120 mg midomafetamine HCl; Fed Treatments with 120 mg midomafetamine HCl

Eligibility Criteria

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

You may qualify if:

• Are fluent in speaking and reading the predominantly used or recognized language of the study site.
• Are able to swallow pills.
• If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 7 days after the last Experimental Session.

You may not qualify if:

• Are not able to give adequate informed consent.
• Have uncontrolled hypertension.
• Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds \[ms\] corrected by Bazett's formula).
• Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
• Have evidence or history of significant medical disorders.
• Have symptomatic liver disease.
• Have history of hyponatremia or hyperthermia.
• Weigh less than 48 kilograms (kg).
• Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
• Are abusing illegal drugs.

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

• William B Smith, M.D.

  Alliance for Multispecialty Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants who are enrolled in the study will be randomized to 1 of 2 dosing regimens, both of which receive the same intervention in opposite order. Group 1 receives a Fasted Treatment followed by a Fed Treatment, while Group 2 receives a Fed Treatment followed by a Fasted Treatment.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 7, 2021
• Study Start: July 28, 2022
• Primary Completion: December 2, 2022
• Study Completion: December 5, 2022
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

US (1)