Healthy VolunteersPhase 1NCT07584720
Study of Midomafetamine in Healthy Adults
A Phase 1 study testing Midomafetamine HCl in people with Healthy Volunteers, run by Resilient Pharmaceuticals at 1 site in United States.
Trial summary
This Phase 1 study is designed to evaluate the safety and tolerability of midomafetamine in healthy adult participants. The study will also assess how the drug is processed in the body and characterize its effects following administration at two dose levels, including evaluation of cardiac safety using… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Midomafetamine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2026to 28 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult participants, 18 to 55 years of age
- Medically healthy as determined by medical history, physical examination, clinical laboratory testing, vital signs, and electrocardiogram
- Able and willing to comply with study procedures
Who cannot join
- History of clinically significant cardiovascular, neurological, or psychiatric disease
- Current or recent substance use disorder, or positive drug or alcohol screen at screening
- Prior exposure to midomafetamine exceeding a protocol-defined limit intended to minimize confounding of safety assessments (no more than 10% of participants may have lifetime prior exposure)
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with interpretation of study results
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1, Single-Center, Open-Label, 2-Cohort Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Midomafetamine at Therapeutic and Supratherapeutic Doses
This Phase 1 study is designed to evaluate the safety and tolerability of midomafetamine in healthy adult participants. The study will also assess how the drug is processed in the body and characterize its effects following administration at two dose levels, including evaluation of cardiac safety using electrocardiographic assessments.
This is a single-center, open-label study in which participants will be enrolled into one of two cohorts receiving either a therapeutic dose or a supratherapeutic dose of midomafetamine. Participants will receive study drug in a split dose administration (an initial dose followed by an additional dose 1.5 hours later) and will undergo clinical assessments, laboratory testing, electrocardiographic monitoring, and monitoring for adverse events.
Information collected from this study will be used to support the ongoing clinical development of midomafetamine.
Read the detailed description
This Phase 1 study is a dedicated safety investigation conducted in healthy adult participants to further characterize the safety and tolerability of midomafetamine under controlled dosing conditions. Participants will receive a split dose administration of midomafetamine (an initial dose of study drug followed by an additional dose 1.5 hours later) in sequential dose cohorts intended to achieve therapeutic and supratherapeutic systemic exposure.
Safety assessments include monitoring of adverse events, clinical laboratory tests, vital signs, and electrocardiographic measurements. Electrocardiographic data, including assessment of corrected QT interval, will be collected to support evaluation of cardiac safety in relation to exposure.
Because midomafetamine produces acute psychoactive effects during the dosing period, pharmacodynamic assessments-including subjective effects-will be collected to support interpretation of safety and tolerability findings. Pharmacokinetic assessments will also be performed to characterize systemic exposure.
This study is not designed to evaluate efficacy or treatment effectiveness for any disease or condition. Information collected from this study will be used to support the ongoing clinical development of midomafetamine.
- Conditions
- Healthy Volunteers
- Being tested
- Midomafetamine HCl
- Keywords
- Midomafetamine, Phase 1 Study, Healthy Volunteers, Safety, Pharmacokinetics, Pharmacodynamics, ECG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midomafetamine HClDrug
Also called Midomafetamine
Midomafetamine HCl is administered orally to study participants.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants receive midomafetamine administered in sequential dose cohorts. One cohort receives a targeted therapeutic dose administered in a split manner, and a subsequent cohort receives a supratherapeutic dose administered in a split manner. Receives: Drug: Midomafetamine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Assessment of adverse events and serious adverse events following administration of midomafetamine.
Measured: From signing of informed consent through End of Study visit (Day 30 +/- 2 Days)
Secondary outcomes (5)
Change from baseline in corrected QT interval (QTc) (ms)
Corrected QT interval (QTc) will be assessed using 12-lead ECG data and summarized as change from baseline at multiple postdose timepoints through 24 hours after dosing.
Measured: Baseline (predose Day 1) and up to 24 hours postdose (Day 2)
Maximum plasma concentration (Cmax) of midomafetamine
Plasma midomafetamine concentrations will be measured, and maximum plasma concentration (Cmax) will be derived from the concentration-time data.
Measured: Predose (Day 1) through 48 hours postdose (Day 3)
Time to maximum plasma concentration (Tmax) of midomafetamine
Plasma midomafetamine concentrations will be measured, and time to maximum plasma concentration (Tmax) will be derived from the concentration-time data.
Measured: Predose (Day 1) through 48 hours postdose (Day 3)
Area under the plasma concentration-time curve (AUC0-24) of midomafetamine
Plasma midomafetamine concentrations will be measured, and area under the concentration-time curve from time 0 to 24 hours (AUC0-24) will be derived from the concentration-time data.
Measured: Predose (Day 1) through 24 hours postdose (Day 2)
Change from baseline in subjective effects Visual Analog Scale (VAS) scores
Subjective effects will be assessed using Visual Analog Scale (VAS) instruments and summarized as change from baseline at multiple postdose timepoints through 24 hours after dosing.
Measured: Baseline (predose Day 1) and up to 24 hours postdose (Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start23 Apr 2026
- Primary completion23 Jul 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Vince Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584720
- Sponsor's protocol ID
- RP-CL-P1-2501
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected in this study will not be shared. Summary level results may be reported in publications and regulatory submissions, as applicable.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Open-Label, 2-Cohort Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Midomafetamine at Therapeutic and Supratherapeutic Doses
- ClinicalTrials.gov ID
- NCT07584720
- Acronym / sponsor ID
- RP-CL-P1-2501
- Conditions
- Healthy Volunteers
- Keywords
- Midomafetamine, Phase 1 Study, Healthy Volunteers, Safety, Pharmacokinetics, Pharmacodynamics, ECG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Vince Clinical Research
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 23 Jul 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 13 May 2026 (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.
This Phase 1 study is designed to evaluate the safety and tolerability of midomafetamine in healthy adult participants. The study will also assess how the drug is processed in the body and characterize its effects following administration at two dose levels, including evaluation of cardiac safety using electrocardiographic assessments.
This is a single-center, open-label study in which participants will be enrolled into one of two cohorts receiving either a therapeutic dose or a supratherapeutic dose of midomafetamine. Participants will receive study drug in a split dose administration (an initial dose followed by an additional dose 1.5 hours later) and will undergo clinical assessments, laboratory testing, electrocardiographic monitoring, and monitoring for adverse events.
Information collected from this study will be used to support the ongoing clinical development of midomafetamine.
Detailed description
This Phase 1 study is a dedicated safety investigation conducted in healthy adult participants to further characterize the safety and tolerability of midomafetamine under controlled dosing conditions. Participants will receive a split dose administration of midomafetamine (an initial dose of study drug followed by an additional dose 1.5 hours later) in sequential dose cohorts intended to achieve therapeutic and supratherapeutic systemic exposure.
Safety assessments include monitoring of adverse events, clinical laboratory tests, vital signs, and electrocardiographic measurements. Electrocardiographic data, including assessment of corrected QT interval, will be collected to support evaluation of cardiac safety in relation to exposure.
Because midomafetamine produces acute psychoactive effects during the dosing period, pharmacodynamic assessments-including subjective effects-will be collected to support interpretation of safety and tolerability findings. Pharmacokinetic assessments will also be performed to characterize systemic exposure.
This study is not designed to evaluate efficacy or treatment effectiveness for any disease or condition. Information collected from this study will be used to support the ongoing clinical development of midomafetamine.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Midomafetamine HClParticipants receive midomafetamine administered in sequential dose cohorts. One cohort receives a targeted therapeutic dose administered in a split manner, and a subsequent cohort receives a supratherapeutic dose administered in a split manner. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult participants, 18 to 55 years of age
- Medically healthy as determined by medical history, physical examination, clinical laboratory testing, vital signs, and electrocardiogram
- Able and willing to comply with study procedures
Key exclusion criteria (4 listed)
- History of clinically significant cardiovascular, neurological, or psychiatric disease
- Current or recent substance use disorder, or positive drug or alcohol screen at screening
- Prior exposure to midomafetamine exceeding a protocol-defined limit intended to minimize confounding of safety assessments (no more than 10% of participants may have lifetime prior exposure)
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with interpretation of study results
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 |
|---|---|---|
| Midomafetamine HClAlso: MidomafetamineMidomafetamine HCl is administered orally to study participants. | Drug | Experimental |
Primary outcome
Incidence of Adverse Events
Time frame: From signing of informed consent through End of Study visit (Day 30 +/- 2 Days)
Assessment of adverse events and serious adverse events following administration of midomafetamine.
5 secondary outcomes
Change from baseline in corrected QT interval (QTc) (ms)
Time frame: Baseline (predose Day 1) and up to 24 hours postdose (Day 2)
Maximum plasma concentration (Cmax) of midomafetamine
Time frame: Predose (Day 1) through 48 hours postdose (Day 3)
Time to maximum plasma concentration (Tmax) of midomafetamine
Time frame: Predose (Day 1) through 48 hours postdose (Day 3)
Area under the plasma concentration-time curve (AUC0-24) of midomafetamine
Time frame: Predose (Day 1) through 24 hours postdose (Day 2)
Change from baseline in subjective effects Visual Analog Scale (VAS) scores
Time frame: Baseline (predose Day 1) and up to 24 hours postdose (Day 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data collected in this study will not be shared. Summary level results may be reported in publications and regulatory submissions, as applicable.
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 HCl in people with Healthy Volunteers, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Adverse Events (time frame: From signing of informed consent through End of Study visit (Day 30 +/- 2 Days)). 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 29 Jun 2026.