A Phase 1 interventional study of Midomafetamine HCl in Pharmacokinetics and Hepatic Impairment, sponsored by Lykos Therapeutics. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Lykos Therapeutics · Phase 1, Interventional, and Basic science
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.
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 16 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Lykos Therapeutics is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Eight participants with moderate hepatic impairment receive a single dose of 80 mg midomafetamine HCl.
Drug: Midomafetamine HCl
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.
Drug: Midomafetamine HCl
80 mg midomafetamine HCl
Also known as: MDMA, 3,4-methylenedioxymethamphetamine, midomafetamine, MDMA HCl
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
Time frame: 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
Time frame: 0 to 5 days after drug administration
Peak MDMA (Cmax)
Maximum value of plasma MDMA in nglml
Time frame: 0 to 5 days after drug administration
Peak MDA (Cmax)
Maximum value of plasma MDA in ng/lml
Time frame: 0 to 5 days after drug administration
Time to maximum (Tmax) MDMA
Time to reach maximum plasma values of MDMA
Time frame: 0 to 5 days after drug administration
Time to maximum (Tmax) MDA
Time to reach maximum plasma values of MDA
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 days after drug administration
Pre-drug Systolic blood pressure (SBP)
First SBP measurement, prior to drug administration, on day of drug administration
Time frame: 0 days after drug administration
Peak Systolic blood pressure (SBP)
Maximum value of SBP measured during day of drug administration
Time frame: 0 days after drug administration
Final systolic blood pressure (SBP)
Last SBP measurement taken on day of drug administration
Time frame: 0 days after drug administration
Pre-drug Diastolic blood pressure (DBP)
First DBP measurement, prior to drug administration, on day of drug administration
Time frame: 0 days after drug administration
Peak Diastolic blood pressure (DBP)
Maximum value of DBP measured during day of drug administration
Time frame: 0 days after drug administration
Final Diastolic blood pressure (DBP)
Last DBP measurement taken on day of drug administration
Time frame: 0 days after drug administration
Pre-drug heart rate (HR)
First HR measurement, prior to drug administration, on day of drug administration
Time frame: 0 days after drug administration
Peak heart rate (HR)
Maximum value of HR measured during day of drug administration
Time frame: 0 days after drug administration
Final heart rate (HR)
Last HR measurement taken on day of drug administration
Time frame: 0 days after drug administration
Pre-drug body temperature (BT)
First body temperature measurement, prior to drug administration, on day of drug administration
Time frame: 0 days after drug administration
Peak body temperature (BT)
Maximum BT value measured during day of drug administration
Time frame: 0 days after drug administration
Final body temperature (BT)
Last BT measurement taken on day of drug administration
Time frame: 0 days after drug administration
Number of AEs reported
Number of AEs reported in each group from enrollment to study end
Time frame: -4 days to 15 days post drug administration
Plan to share: Yes — We will share outcome data appearing in any published reports upon request.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Lykos Therapeutics