Clinical Trials Logo

Clinical Trial Summary

This protocol is a Phase 1 open-label study with a primary purpose of evaluating the food effect of a high calorie meal as compared to fasting conditions on the relative bioavailability of oral MDMA capsules in healthy volunteers. In addition, increases in heart rate are 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 electrocardiogram (ECG). Directly comparing the pharmacokinetics of MDMA and its active metabolite MDA, in a within-subject crossover study will allow for assessment of any impacts of food and inform product labeling.


Clinical Trial Description

The sponsor has completed a Phase 3 study of MDMA-assisted therapy for individuals diagnosed with severe PTSD demonstrating the safety and efficacy of this treatment. However, the effect of food intake on the absorption and bioavailability of orally administered MDMA is not yet well characterized. 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: - Fasted Treatments: 10 hours of fasting followed by MDMA administration with 240 mL water. - Fed Treatments: A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal will be consumed within 30 minutes of MDMA administration. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05147402
Study type Interventional
Source Lykos Therapeutics
Contact
Status Completed
Phase Phase 1
Start date July 28, 2022
Completion date December 5, 2022

See also
  Status Clinical Trial Phase
Completed NCT04092725 - Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects Phase 1
Completed NCT04181008 - Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers Early Phase 1
Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed NCT04406415 - Oral Nafamostat in Healthy Volunteers Phase 1
Not yet recruiting NCT05421312 - Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip Phase 4
Completed NCT02534753 - A Pharmacokinetics Study of Intravenous Ascorbic Acid Phase 1
Completed NCT01682408 - Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability Phase 1
Completed NCT01976078 - Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents N/A
Completed NCT01636024 - To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594 Phase 1
Completed NCT01415102 - A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372. Phase 1
Completed NCT01208155 - Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets Phase 1
Completed NCT01214941 - Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol Phase 4
Completed NCT01260025 - Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor Phase 1
Completed NCT01276119 - The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males Phase 1
Completed NCT00730145 - A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis Phase 1
Completed NCT00983242 - Drug-Drug Interaction Between Colchicine and Verapamil ER Phase 1
Completed NCT00984009 - A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice Phase 1
Completed NCT00746499 - Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women. Phase 1
Completed NCT01055964 - a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients Phase 3
Completed NCT00747721 - Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU Phase 1