A Phase 1 interventional study of midomafetamine in Pharmacokinetics, sponsored by Lykos Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Lykos Therapeutics · Phase 1, Interventional, and Basic science
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.
This phase I, open-label, randomized sequence, multi-dose, 2-period crossover pharmacokinetic (PK) study assesses the effect of food on the relative bioavailability of MDMA. In addition, an increase in heart rate is anticipated following MDMA administration. Therefore, the secondary purpose of this study is to evaluate the effect of food on the safety and tolerability of oral MDMA, as well as MDMA effects on ECG.
Potential participants will be identified by the clinical site and invited to phone screen for the study. Following informed consent, potential study participants will undergo screening examinations to assess eligibility for inclusion in the study.
Participants will be randomized to receive one of two conditions before the other:
Participants will be confined at the Clinical Research Unit (CRU) for each Dosing Session from the time of check-in on the night before dosing until discharge 48 hours after dosing. MDMA will be administered on Day 1 following the treatment sequence to which the participant has been randomized. Concentration-time profiles of MDMA will be determined in the time interval 0-72 hours post-dose, according to the expected PK profiles of MDMA and its metabolites. Participants will remain at the CRU for at least 36 hours after administration of study drug for collection of serial blood samples for PK analysis and safety monitoring. An additional outpatient visit will occur 72 hours after dosing to collect a final PK sample and perform safety assessments.
Lykos Therapeutics is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
100 mg midomafetamine (equivalent to 120 mg midomafetamine HCl).
Also known as: 3,4-methylenedioxymethamphetamine, midomafetamine HCl, MDMA
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.
Time frame: 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
Time frame: 0 to 1 day after drug administration
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Lykos Therapeutics