Clinical TrialHealthy VolunteersMDMAMDMACompleted

Food Effects on Bioavailability of MDMA in Healthy Volunteers (MPKF)

Phase I open-label randomized, two-period crossover PK study (n=14) comparing oral MDMA 100 mg under fed versus fasted conditions in healthy volunteers to assess food effects on bioavailability and safety.

Target Enrollment
14 participants
Study Type
Phase I interventional
Design
Randomized

Detailed Description

Randomized sequence, two-period crossover comparing fasted (≥10 h) and fed (high‑fat, 800–1000 kcal) conditions; each period includes a single oral dose of MDMA (100 mg midomafetamine, ≈120 mg HCl equivalent).

Participants are confined at the clinical research unit from check-in the night before dosing until at least 48 hours after dosing for PK sampling (0–72 h) and safety monitoring; an additional outpatient visit at 72 hours collects final PK and safety assessments.

Study Protocol

Preparation

1 sessions
30 min each

Dosing

2 sessions
2880 min each

Integration

1 sessions
30 min each

Study Arms & Interventions

Fasted

active comparator

Overnight fast (≥10 h) then 100 mg midomafetamine (120 mg HCl equivalent) with 240 mL water; no food ≥4 h post-dose.

Interventions

  • MDMA100 mg
    via Oral• single dose

    100 mg midomafetamine (≈120 mg midomafetamine HCl); given after ≥10 h fast; 240 mL water; no food ≥4 h post-dose.

Fed

active comparator

High-fat, high-calorie meal (≈800–1000 kcal, ~50% fat) consumed; 100 mg midomafetamine administered 30 minutes after start of meal.

Interventions

  • MDMA100 mg
    via Oral• single dose

    Meal consumed within 30 minutes; 100 mg midomafetamine given 30 minutes after meal start; 240 mL water.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 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.

Exclusion Criteria

  • Exclusion Criteria:
  • 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.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment14 participants
  • Timeline
    Start: 2022-04-06
    End: 2022-11-09
  • Compounds
    MDMAMDMA
  • Topic
    Healthy Volunteers

Locations

Alliance for Multispecialty Research LLC — Knoxville, Tennessee, United States

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