Fasted Treatments with 120 mg midomafetamine HCl for Pharmacokinetics (MPKF Trial)

Phase 1

Waitlist Available

Led By William B Smith, M.D.

Research Sponsored by MAPS Public Benefit Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 1 day after drug administration

Awards & highlights

No Placebo-Only Group

Summary

This trial will give MDMA to people after either a fasting or high calorie meal to study how food affects the body's ability to process the drug. They will also monitor heart rate and any changes on an electrocardiogram.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 1 day after drug administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 1 day after drug administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 1 day after drug administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Fasted Treatments with 120 mg midomafetamine HClActive Control1 Intervention

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.

Group II: Fed Treatments with 120 mg midomafetamine HClActive Control1 Intervention

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.

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