Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of EMP-01 in Healthy Adult Volunteers
- Conditions
- Post-traumatic stress disorder (PTSD)Mental Health - Other mental health disorders
- Registration Number
- ACTRN12622001335785
- Lead Sponsor
- EmpathBio Australia Pty. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 32
Each participant must meet all the following criteria to be enrolled in this study:
1. Male or female aged between 18 and 55 years of age, inclusive, at time of consent.
2. Female participants must have a negative serum pregnancy test result at Screening (all cohorts) and Day 8 (Cohort 2 only), and a negative urine pregnancy test at admission to the CRU on Day -1 (all cohorts), are not currently breast-feeding, and meet one of the following criteria:
a. Undergone 1 of the following sterilization procedures at least 6 months before the first dosing:
i. hysteroscopic sterilization
ii. bilateral tubal ligation or bilateral salpingectomy
iii. hysterectomy
iv. bilateral oophorectomy
v. Essure sterilization; or
b. Be postmenopausal with amenorrhea for at least 1 year before the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status;
c. Female participants of childbearing potential must use at least one of the following protocol-specified highly effective methods or effective methods of birth control AND must agree to use barrier contraception (male condom) during heterosexual intercourse, from the time of Screening until at least 90 days after EMP-01 administration.
Highly effective methods of birth control include:
i Implant contraceptive (eg, Jadelle®)
ii. Intrauterine device (IUD) containing either copper or levonorgestrel (eg, Mirena®)
iii. Male sterilization (vasectomy).
Effective methods of birth control include:
i. Injectable contraceptive (eg, Depo Provera)
ii. Oral contraceptive pill (combined hormonal contraceptive pill or progestogen-only mini-pill”)
iii. Vaginal contraceptive ring (eg, NuvaRing®)
It is not necessary to use any other method of contraception when complete abstinence is elected. Women of childbearing potential (WOCBP) who choose complete abstinence must continue to have pregnancy tests as per protocol. The reliability of sexual abstinence needs to be evaluated by the Investigator in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.
3. Male participants must agree to and comply with using a double barrier method of contraception or sexual abstinence, and not donate sperm, for the duration of the study (from signing of consent to EOS visit) and for 120 days after EMP-01 administration.
For participants who are exclusively in same sex relationships, contraceptive requirements do not apply. If a participant who is in a same sex relationship at the time of signing the Informed Consent Form (ICF) becomes engaged in a heterosexual relationship, they must
agree to use contraception as described.
4. Is judged to be in good health based on medical history, physical examination, vital signs measurements, and laboratory safety tests performed at the screening visit and/or before the first dose of IP.
5. Participant weighs greater than equal 45 kg and less than equal 100 kg and has a body mass index (BMI) between 18.0 and 32.0 kg/m2 , inclusive, at Screening
6. Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the Schedule of Assessments.
7. Participants who smoke no more than 2 cigarettes, pipes, cigars e-cigarettes or equivalent per week, including nicotine products, from 3 months prior to Screening, can be included in the study and must be willing to abstain from smoking/using nicotine products for 24 hours prior to IP adminis
Participants who meet any of the following criteria will be excluded from this study:
1. Known allergy or hypersensitivity to MDMA or any of the excipients in the formulation.
2. History of cardiovascular, cerebrovascular, or peripheral vascular disease, including but not limited to unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, hypertension, hypotension, bradycardia, or tachycardia.
3. Clinically significant vital signs measurements at Screening. Clinically significant screening values measured after 5 minutes of rest in a supine position include:
- Abnormal SBP (less than 80 mmHg or more than 140 mmHg)
- Abnormal diastolic blood pressure (less than 40 mmHg or greater than 90 mmHg)
- Abnormal respiratory rate (less than 10 RR or more than 22 RR).
The BP and RR may be repeated up to 2 times at the PI’s discretion for confirmation (with 2 of 3 BPs or RRs being below the threshold).
4. Past or current history of significant mental, behavioral, or neurodevelopmental disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) including, but not limited to, diagnoses of: organic, including symptomatic, mental disorders; mental and behavioral disorders due to psychoactive substance use; schizophrenia, schizotypal, and delusional disorders; mood (affective) disorders (current only); neurotic, stress-related, and somatoform disorders; or disorders of adult personality and behavior, as assessed by the MINI screen.
5. Family (first degree relative) history of psychotic disorders such as bipolar disorder, schizophrenia, or depression with psychotic features according to the DSM-V.
6. Current suicide ideation as assessed by the C-SSRS (Baseline/Screening) up to 1 month prior to Screening; participants with a lifetime history of suicidal ideation may be excluded at the discretion of the PI or designee.
7. History of more than 25 lifetime administrations of psychedelic drugs or MDMA, or last use of a psychedelic drug or MDMA within 6 months before the Screening visit.
8. History of seizures or convulsions, with the exception of pediatric febrile seizures or increased intra-cranial pressure.
9. Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years prior to Screening.
10. Has a clinically significant history or presence of ECG findings as judged by the PI or designee at Screening, including:
a. Abnormal sinus rhythm (HR less than 40 bpm or more than 100 bpm)
b. Average QT interval corrected using Fridericia’s formula (QTcF) interval duration greater than 450 msec (males) or greater than 470 msec (females)
c. Average QRS interval greater than 120 msec after being confirmed by manual over-read
d. Average PR interval greater than 220 msec.
The ECG may be repeated up to 2 times at the PI’s discretion for confirmation (with 2 of 3 ECGs being below the threshold).
11. Has clinically significant laboratory abnormalities at Screening (confirmed by repeat assessment) including:
a. Hemoglobin less than equal 130 g per L (males) or less than equal 115 g per L (females)
b. Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) laboratory
values greater than 1.5 × upper normal limits, or bilirubin greater than 2 × upper normal limits. Participants with Gilbert’s syndrome are not excluded.
c. An estimated creatinine clearance of less than 80 mL per min as determined by the Cockcro
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method