PharmacokineticsPhase 1NCT03606538
MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function
A Phase 1 study testing Midomafetamine HCl in people with Pharmacokinetics and Hepatic Impairment, run by Resilient Pharmaceuticals at 1 site in United States.
Trial summary
The goal of this clinical trial to learn how MDMA is processed in people with abnormal liver function. The main questions it aims to answer are: Do people with abnormal liver function experience greater absorption of MDMA? Does the dose of MDMA need to be adjusted in people with abnormal liver function? Researchers… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Hepatic Impairment
- What is being tested?
- Midomafetamine HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2026to Dec 2028
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with moderate hepatic impairment (class B according to Child- Pugh's criteria).
- Participants with normal hepatic function: no clinically significant findings from medical history, physical examination, laboratory values within protocol defined parameters.
- Age 18 to 65 years.
- Weight > 45 kg
- Negative Carbohydrate Deficient Transferrin blood test at Screening and negative breathalyzer alcohol test prior to trial drug administration.
- Negative urine test for drugs of abuse at Screening and prior to trial drug administration.
- Able to comprehend and willing to sign an informed consent form.
Who cannot join
- Have a current psychiatric diagnosis.
- Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control.
- Have acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within 2 weeks.
- Have autoimmune liver disease; esophageal variceal bleeding within 6 months prior to screening, unless successfully treated with banding, or gastric varices.
- Have spontaneous bacterial peritonitis within 3 months prior to screening.
- Have a portosystemic shunt, organ transplant, Wilson's disease, cholestatic liver disease (e g, primary biliary cirrhosis or primary sclerosing cholangitis)
Show all 16Show fewer
- Evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular (including controlled hyper-tension), coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration.
- For moderate hepatic impairment participants: have clinically significant laboratory findings except as related to hepatic impairment.
- For control participants only: have clinically significant laboratory results outside the normal limits, including AST >48 U/L, ALT > 55 U/L, GGT > 48 U/L, bilirubin > 1.2 mg/dL or hemoglobin < 12 g/dL.
- Have a history of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject.
- Have any positive test for drugs of abuse and /or alcohol at screening.
- Have a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of > 450 ms in men, > 470 ms in women on the screening ECG.
- Have a PR interval > 240 ms, QRS > 110 ms or a history of prolongation of QT interval.
- Have mental incapacity, unwillingness or language barriers precluding adequate understanding or subject co-operation.
- Are unwilling to stay in the clinical unit for the required duration as per the protocol.
- Have a known or suspected allergy to trial product or related products.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Recruitment Officer contact
United States1 site
Alliance for Multispecialty Research, LLC.
Knoxville, Tennessee, 37920
Study coordinator
About this study
Official title: A Phase I, Open Label, Study of 3,4-Methylenedioxymethamphetamine (MDMA) Tolerability and Pharmacokinetics in Subjects With Moderate Hepatic Impairment Compared to Matched Control Subjects With Normal Hepatic Function
The goal of this clinical trial to learn how MDMA is processed in people with abnormal liver function.
The main questions it aims to answer are:
Do people with abnormal liver function experience greater absorption of MDMA? Does the dose of MDMA need to be adjusted in people with abnormal liver function?
Researchers will compare people with abnormal liver function to people with normal liver function.
Participants will receive a single dose of MDMA then undergo periodic vitals measurements. They will remain at the study site for two more days undergoing more vitals measurements and having subjective effects and adverse events measured.
Read the detailed description
This protocol is for a Phase 1, open-label study with a primary purpose of evaluating the effect of moderate hepatic impairment in the pharmacokinetics of MDMA and its active metabolite, 3,4-methylene-dioxyamphetamine (MDA), and determining whether an adjustment to the dosage would be indicated in this group of patients in comparison to patients with normal liver function. Because people with moderate hepatic impairment may experience greater exposure to drug than people without it, the secondary purpose of this study is to evaluate the effect of moderate hepatic impairment on the safety and tolerability of oral MDMA, with special attention to ECG data. The study will enroll eight participants, ages 18 to 65 years old, with moderate hepatic impairment, and eight healthy controls with normal hepatic function who are matched with participants with moderate impaired hepatic function on the basis of age, weight and gender.
Participants who give their written informed consent will be screened for study participation that will include a physical examination, assessing current and prior medical and physical health, and a baseline electrocardiogram (ECG) reading. If applicable, they may begin tapering off any contraindicated psychiatric medication. Participants who meet study criteria will receive a single dose of 80 mg midomafetamine HCl on the first day of a three-day stay at the study site.
Blood will be collected periodically in order to calculate pharmacokinetics of MDMA and its active metabolite methylenedioxyamphetamine (MDA). Blood will be collected ten times on Day 1 (-5 min, 0 hours (drug administration), 0.5 h, 1, 2, 4, 6, 7, 10 and 12 hours), starting five minutes before drug administration. Subjective effects of MDMA will be assessed through 15 visual analog scales at similar time points to blood collection, at 0.5, 1, 2, 4, 6 and 7 hours post-drug. There will be six 12-lead ECG measurements on Day 1.
Participants will remain at the study site for two more days. Drug safety will be assessed by measuring blood pressure, heart rate and body temperature after MDMA administrations, collecting adverse events throughout the study and measuring suicidal thoughts or behaviors with the Columbia Suicide Severity Rating Scale (C-SSRS). Blood will be collected 24 and 36 hours after drug administration, and ECG will be performed on Day 2, and a single ECG and blood draw will occur on Day 3, 4 and 5. Participants will return for eight and 15 days after drug administration. They will have a single blood draw on each day. The study ends 15 days after drug administration, approximately one month after screening.
The primary outcome measure will be area under the curve from dosing to last dose (AUC) of MDMA and MDA. AUC will be computed from plasma collected multiple times after a single dose of MDMA, twice on the day following the day of drug administration, and once daily for three more days. Other pharmacokinetic measures will be maximal values of MDMA and MDA (Cmax), and time to reach maximum MDMA and MDA levels (Tmax). Safety measures will also include a comparison of subjective effects across groups, ECG readings, number of adverse events, and suicidal ideation or behavior as measured via C-SSRS during the study.
- Conditions
- Pharmacokinetics, Hepatic Impairment
- Being tested
- Midomafetamine HCl
- Keywords
- MDMA, metabolism, methylenedioxymethamphetamine, midomafetamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midomafetamine HClDrug
Also called MDMA, 3,4-methylenedioxymethamphetamine, midomafetamine, MDMA HCl
80 mg midomafetamine HCl
| Study group | Role | What they receive |
|---|---|---|
| Moderate hepatic impairment | Experimental | Eight participants with moderate hepatic impairment receive a single dose of 80 mg midomafetamine HCl. Receives: Drug: Midomafetamine HCl |
| Normal hepatic function | Experimental | Eight participants, each matched on age, weight and gender to a participant with moderate hepatic impairment, receive a single dose of 80 mg midomafetamine HCl. Receives: Drug: Midomafetamine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve from dosing time to last measurement (AUC(0-t)) - MDMA
Computed exposure to MDMA using blood collected periodically at 1, 2, 4, 6, 7, 10, 12, 24, 36, 48, 72 and 96 h post drug
Measured: 0 to 5 days after drug administration
Area under curve from dosing time to last measurement (AUC(0-t) MDA
Computed exposure to MDA using blood collected periodically at 1, 2, 4, 6, 7, 10, 12, 24, 36, 48, 72 and 96 h post-MDMA administration
Measured: 0 to 5 days after drug administration
Secondary outcomes (31)
Peak MDMA (Cmax)
Maximum value of plasma MDMA in nglml
Measured: 0 to 5 days after drug administration
Peak MDA (Cmax)
Maximum value of plasma MDA in ng/lml
Measured: 0 to 5 days after drug administration
Time to maximum (Tmax) MDMA
Time to reach maximum plasma values of MDMA
Measured: 0 to 5 days after drug administration
Time to maximum (Tmax) MDA
Time to reach maximum plasma values of MDA
Measured: 0 to 5 days after drug administration
Area under curve from dosing time to infinity (AUC(0-infinity)) - MDMA
Computed exposure to MDMA using blood collected periodically at 1, 2, 4, 6, 7, 10, 12, 24, 36, 48, 72 and 96 h post drug
Measured: 0 to 5 days after drug administration
Area under curve from dosing time to infinity (AUC(0-infinity)) - MDA
Computed exposure to MDA using blood collected periodically at 1, 2, 4, 6, 7, 10, 12, 24, 36, 48, 72 and 96 h post drug
Measured: 0 to 5 days after drug administration
90% CL between hepatic impaired and no hepatic impairment groups for AUC (0-t)
90% confidence interval (CI) for the ratio of population geometric means between moderate hepatic impairment and normal hepatic function for AUC (0-t)
Measured: 0 to 5 days after drug administration
90% CL between hepatic impaired and no hepatic impairment groups for AUC (0-infinity)
90% confidence interval (CI) for the ratio of population geometric means between moderate hepatic impairment and normal hepatic function for AUC(0-infinity)
Measured: 0 to 5 days after drug administration
90% CL between hepatic impaired and no hepatic impairment groups for Cmax
90% confidence interval (CI) for the ratio of population geometric means between moderate hepatic impairment and normal hepatic function for Cmax
Measured: 0 to 5 days after drug administration
Change in QTcI - Baseline to 0.5 h post drug
Change in ECG QTcl from Baseline compared to 0.5 h post MDMA
Measured: 0 days after drug administration
Change in QTcI - Baseline to 2 h post-drug
Change in ECG QTcl from Baseline compared to 2 h post MDMA
Measured: 0 days after drug administration
Change in QTcI Baseline to 4 h post-drug
Change in ECG QTcl from Baseline compared to 4 h post MDMA
Measured: 0 days after drug administration
Change in QTcI Baseline to 6 h post-drug
Change in ECG QTcl from Baseline compared to 6 h post MDMA
Measured: 0 days after drug administration
Change in QTcI Baseline to 7 h post-drug
Change in ECG QTcl from Baseline compared to 7 h post MDMA
Measured: 0 days after drug administration
Change in QTcI Baseline to 1 d post-drug
Change in ECG QTcl from Baseline compared to 1 d post MDMA
Measured: 1 day after drug administration
Change in QTcI Baseline to 2 d post-drug
Change in ECG QTcl from Baseline compared to 2 d post MDMA
Measured: 2 days after drug administration
Change in QTcI Baseline to 3 d post-drug
Change in ECG QTcl from Baseline compared to 3 d post MDMA
Measured: 3 days after drug administration
Change in QTcI Baseline to 4 d post-drug
Change in ECG QTcl from Baseline compared to 4 d post MDMA
Measured: 4 days after drug administration
Pre-drug Systolic blood pressure (SBP)
First SBP measurement, prior to drug administration, on day of drug administration
Measured: 0 days after drug administration
Peak Systolic blood pressure (SBP)
Maximum value of SBP measured during day of drug administration
Measured: 0 days after drug administration
Final systolic blood pressure (SBP)
Last SBP measurement taken on day of drug administration
Measured: 0 days after drug administration
Pre-drug Diastolic blood pressure (DBP)
First DBP measurement, prior to drug administration, on day of drug administration
Measured: 0 days after drug administration
Peak Diastolic blood pressure (DBP)
Maximum value of DBP measured during day of drug administration
Measured: 0 days after drug administration
Final Diastolic blood pressure (DBP)
Last DBP measurement taken on day of drug administration
Measured: 0 days after drug administration
Pre-drug heart rate (HR)
First HR measurement, prior to drug administration, on day of drug administration
Measured: 0 days after drug administration
Peak heart rate (HR)
Maximum value of HR measured during day of drug administration
Measured: 0 days after drug administration
Final heart rate (HR)
Last HR measurement taken on day of drug administration
Measured: 0 days after drug administration
Pre-drug body temperature (BT)
First body temperature measurement, prior to drug administration, on day of drug administration
Measured: 0 days after drug administration
Peak body temperature (BT)
Maximum BT value measured during day of drug administration
Measured: 0 days after drug administration
Final body temperature (BT)
Last BT measurement taken on day of drug administration
Measured: 0 days after drug administration
Number of AEs reported
Number of AEs reported in each group from enrollment to study end
Measured: -4 days to 15 days post drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start29 Mar 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Matched group comparison of pharmacokinetics and metabolism of single dose of 80 mg MDMA in participants with moderate hepatic impairment and participants with normal hepatic function and matched on age, weight and gender.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janel Long-Boyle, PharmD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606538
- Sponsor's protocol ID
- MPKH
- Status last verified
- Oct 2024
- First submitted
- 20 Jul 2018
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share outcome data appearing in any published reports upon request.
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 I, Open Label, Study of 3,4-Methylenedioxymethamphetamine (MDMA) Tolerability and Pharmacokinetics in Subjects With Moderate Hepatic Impairment Compared to Matched Control Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT03606538
- Acronym / sponsor ID
- MPKH
- Conditions
- Pharmacokinetics, Hepatic Impairment
- Keywords
- MDMA, metabolism, methylenedioxymethamphetamine, midomafetamine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 Jul 2018 (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 to learn how MDMA is processed in people with abnormal liver function.
The main questions it aims to answer are:
Do people with abnormal liver function experience greater absorption of MDMA? Does the dose of MDMA need to be adjusted in people with abnormal liver function?
Researchers will compare people with abnormal liver function to people with normal liver function.
Participants will receive a single dose of MDMA then undergo periodic vitals measurements. They will remain at the study site for two more days undergoing more vitals measurements and having subjective effects and adverse events measured.
Detailed description
This protocol is for a Phase 1, open-label study with a primary purpose of evaluating the effect of moderate hepatic impairment in the pharmacokinetics of MDMA and its active metabolite, 3,4-methylene-dioxyamphetamine (MDA), and determining whether an adjustment to the dosage would be indicated in this group of patients in comparison to patients with normal liver function. Because people with moderate hepatic impairment may experience greater exposure to drug than people without it, the secondary purpose of this study is to evaluate the effect of moderate hepatic impairment on the safety and tolerability of oral MDMA, with special attention to ECG data. The study will enroll eight participants, ages 18 to 65 years old, with moderate hepatic impairment, and eight healthy controls with normal hepatic function who are matched with participants with moderate impaired hepatic function on the basis of age, weight and gender.
Participants who give their written informed consent will be screened for study participation that will include a physical examination, assessing current and prior medical and physical health, and a baseline electrocardiogram (ECG) reading. If applicable, they may begin tapering off any contraindicated psychiatric medication. Participants who meet study criteria will receive a single dose of 80 mg midomafetamine HCl on the first day of a three-day stay at the study site.
Blood will be collected periodically in order to calculate pharmacokinetics of MDMA and its active metabolite methylenedioxyamphetamine (MDA). Blood will be collected ten times on Day 1 (-5 min, 0 hours (drug administration), 0.5 h, 1, 2, 4, 6, 7, 10 and 12 hours), starting five minutes before drug administration. Subjective effects of MDMA will be assessed through 15 visual analog scales at similar time points to blood collection, at 0.5, 1, 2, 4, 6 and 7 hours post-drug. There will be six 12-lead ECG measurements on Day 1.
Participants will remain at the study site for two more days. Drug safety will be assessed by measuring blood pressure, heart rate and body temperature after MDMA administrations, collecting adverse events throughout the study and measuring suicidal thoughts or behaviors with the Columbia Suicide Severity Rating Scale (C-SSRS). Blood will be collected 24 and 36 hours after drug administration, and ECG will be performed on Day 2, and a single ECG and blood draw will occur on Day 3, 4 and 5. Participants will return for eight and 15 days after drug administration. They will have a single blood draw on each day. The study ends 15 days after drug administration, approximately one month after screening.
The primary outcome measure will be area under the curve from dosing to last dose (AUC) of MDMA and MDA. AUC will be computed from plasma collected multiple times after a single dose of MDMA, twice on the day following the day of drug administration, and once daily for three more days. Other pharmacokinetic measures will be maximal values of MDMA and MDA (Cmax), and time to reach maximum MDMA and MDA levels (Tmax). Safety measures will also include a comparison of subjective effects across groups, ECG readings, number of adverse events, and suicidal ideation or behavior as measured via C-SSRS during the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Matched group comparison of pharmacokinetics and metabolism of single dose of 80 mg MDMA in participants with moderate hepatic impairment and participants with normal hepatic function and matched on age, weight and gender.
| Arm | Type | Receives |
|---|---|---|
| Moderate hepatic impairment | Experimental | Drug: Midomafetamine HClEight participants with moderate hepatic impairment receive a single dose of 80 mg midomafetamine HCl. |
| Normal hepatic function | Experimental | Drug: Midomafetamine HClEight participants, each matched on age, weight and gender to a participant with moderate hepatic impairment, receive a single dose of 80 mg midomafetamine HCl. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with moderate hepatic impairment (class B according to Child- Pugh's criteria).
- Participants with normal hepatic function: no clinically significant findings from medical history, physical examination, laboratory values within protocol defined parameters.
- Age 18 to 65 years.
- Weight > 45 kg
- Negative Carbohydrate Deficient Transferrin blood test at Screening and negative breathalyzer alcohol test prior to trial drug administration.
Key exclusion criteria (16 listed)
- Have a current psychiatric diagnosis.
- Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control.
- Have acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within 2 weeks.
- Have autoimmune liver disease; esophageal variceal bleeding within 6 months prior to screening, unless successfully treated with banding, or gastric varices.
- Have spontaneous bacterial peritonitis within 3 months prior to screening.
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: MDMA, 3,4-methylenedioxymethamphetamine, midomafetamine, MDMA HCl80 mg midomafetamine HCl | Drug | Moderate hepatic impairment, Normal hepatic function |
Primary outcome
Area under curve from dosing time to last measurement (AUC(0-t)) - MDMA
Time frame: 0 to 5 days after drug administration
Computed exposure to MDMA using blood collected periodically at 1, 2, 4, 6, 7, 10, 12, 24, 36, 48, 72 and 96 h post drug
Area under curve from dosing time to last measurement (AUC(0-t) MDA
Time frame: 0 to 5 days after drug administration
Computed exposure to MDA using blood collected periodically at 1, 2, 4, 6, 7, 10, 12, 24, 36, 48, 72 and 96 h post-MDMA administration
31 secondary outcomes
Peak MDMA (Cmax)
Time frame: 0 to 5 days after drug administration
Peak MDA (Cmax)
Time frame: 0 to 5 days after drug administration
Time to maximum (Tmax) MDMA
Time frame: 0 to 5 days after drug administration
Time to maximum (Tmax) MDA
Time frame: 0 to 5 days after drug administration
Area under curve from dosing time to infinity (AUC(0-infinity)) - MDMA
Time frame: 0 to 5 days after drug administration
Area under curve from dosing time to infinity (AUC(0-infinity)) - MDA
Time frame: 0 to 5 days after drug administration
90% CL between hepatic impaired and no hepatic impairment groups for AUC (0-t)
Time frame: 0 to 5 days after drug administration
90% CL between hepatic impaired and no hepatic impairment groups for AUC (0-infinity)
Time frame: 0 to 5 days after drug administration
90% CL between hepatic impaired and no hepatic impairment groups for Cmax
Time frame: 0 to 5 days after drug administration
Change in QTcI - Baseline to 0.5 h post drug
Time frame: 0 days after drug administration
Change in QTcI - Baseline to 2 h post-drug
Time frame: 0 days after drug administration
Change in QTcI Baseline to 4 h post-drug
Time frame: 0 days after drug administration
Change in QTcI Baseline to 6 h post-drug
Time frame: 0 days after drug administration
Change in QTcI Baseline to 7 h post-drug
Time frame: 0 days after drug administration
Change in QTcI Baseline to 1 d post-drug
Time frame: 1 day after drug administration
Change in QTcI Baseline to 2 d post-drug
Time frame: 2 days after drug administration
Change in QTcI Baseline to 3 d post-drug
Time frame: 3 days after drug administration
Change in QTcI Baseline to 4 d post-drug
Time frame: 4 days after drug administration
Pre-drug Systolic blood pressure (SBP)
Time frame: 0 days after drug administration
Peak Systolic blood pressure (SBP)
Time frame: 0 days after drug administration
Final systolic blood pressure (SBP)
Time frame: 0 days after drug administration
Pre-drug Diastolic blood pressure (DBP)
Time frame: 0 days after drug administration
Peak Diastolic blood pressure (DBP)
Time frame: 0 days after drug administration
Final Diastolic blood pressure (DBP)
Time frame: 0 days after drug administration
Pre-drug heart rate (HR)
Time frame: 0 days after drug administration
Peak heart rate (HR)
Time frame: 0 days after drug administration
Final heart rate (HR)
Time frame: 0 days after drug administration
Pre-drug body temperature (BT)
Time frame: 0 days after drug administration
Peak body temperature (BT)
Time frame: 0 days after drug administration
Final body temperature (BT)
Time frame: 0 days after drug administration
Number of AEs reported
Time frame: -4 days to 15 days post drug administration
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 30 Oct 2024.
- Individual participant dataSharing planned: Yes. We will share outcome data appearing in any published reports upon request.
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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.
Recruitment Officer contact
Janel Long-Boyle, PharmD, PhD principal investigator
University of California, San Francisco
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 Pharmacokinetics and Hepatic Impairment, 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 7 inclusion and 16 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: opening soon, 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?
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?
Contact Recruitment Officer (recruitment@lykospbc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve from dosing time to last measurement (AUC(0-t)) - MDMA (time frame: 0 to 5 days 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.