PharmacokineticsPhase 1MPKFNCT05147402
Food Effects on Bioavailability of MDMA in Healthy Volunteers
A Phase 1 study testing midomafetamine in people with Pharmacokinetics, run by Resilient Pharmaceuticals at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- midomafetamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2022to 5 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alliance for Multispecialty Research LLC
Knoxville, Tennessee, 37920
About this study
Official title: A Phase 1, Single Center, Open Label, Randomized Sequence, 2-period Cross-over Study to Determine the Effect of Food on the Relative Bioavailability of 3,4-methylenedioxymethamphetamine (MDMA) Oral Formulation in Healthy Volunteers
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.
Read the detailed description
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.
- Conditions
- Pharmacokinetics
- Being tested
- midomafetamine
- Keywords
- MDMA, Metabolism, Methylenedioxymethamphetamine, midomafetamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midomafetamineDrug
Also called 3,4-methylenedioxymethamphetamine, midomafetamine HCl, MDMA
100 mg midomafetamine (equivalent to 120 mg midomafetamine HCl).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: midomafetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 0 to 1 day after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start28 Jul 2022
- Primary completion2 Dec 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William B Smith, M.D., Principal investigator, Alliance for Multispecialty Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147402
- Sponsor's protocol ID
- MPKF
- Acronym
- MPKF
- Status last verified
- Oct 2024
- First submitted
- 24 Nov 2021
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Center, Open Label, Randomized Sequence, 2-period Cross-over Study to Determine the Effect of Food on the Relative Bioavailability of 3,4-methylenedioxymethamphetamine (MDMA) Oral Formulation in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05147402
- Acronym / sponsor ID
- MPKF / MPKF
- Conditions
- Pharmacokinetics
- Keywords
- MDMA, Metabolism, Methylenedioxymethamphetamine, midomafetamine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fasted Treatments with 120 mg midomafetamine HCl | Active comparator | Drug: midomafetamineFollowing 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. |
| Fed Treatments with 120 mg midomafetamine HCl | Active comparator | Drug: midomafetamineA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midomafetamineAlso: 3,4-methylenedioxymethamphetamine, midomafetamine HCl, MDMA100 mg midomafetamine (equivalent to 120 mg midomafetamine HCl). | Drug | Fasted Treatments with 120 mg midomafetamine HCl, Fed Treatments with 120 mg midomafetamine HCl |
Primary outcome
Area under the curve from dosing time to last measurement - Plasma concentration of MDMA
Time frame: 0 to 1 day after drug administration
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.
Area under the curve from dosing time to last measurement - Plasma concentration of active metabolite MDA
Time frame: 0 to 1 day after drug administration
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William B Smith, M.D. principal investigator
Alliance for Multispecialty Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing midomafetamine in people with Pharmacokinetics, run by Resilient Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve from dosing time to last measurement - Plasma concentration of MDMA (time frame: 0 to 1 day after drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.