A trial to assess the effects and safety of SYT-510 treatment in people with anxiety
Overview
SYT-510 (the trial medicine) is an experimental new medicine being tested as a potential treatment of anxiety symptoms. We hope the study medicine will increase the amount of a type of neuromodulator called endocannabinoids. Neuromodulators are substances which allow cells in the brain to communicate with each other. Endocannabinoids help regulate many brain functions, such as mood, appetite, sleep, and how people experience pain.
We’re doing this trial in anxious people to understand the potential of the trial medicine to improve their symptoms. We hope the trial medicine will have fewer side effects than currently available treatments.
What will it involve:
Taking part involves a screening visit lasting about 4 hours, two treatment sessions, each requiring completion of a questionnaire at home on day 1 and coming to the Clinical Research Facility in Kings College Hospital, Camberwell, London early the following morning (day 2) for the dosing day assessments including an overnight stay, going home the following morning. The treatment sessions are separated by 1-2 weeks. The final follow-up visit will occur 1-2 weeks after the second treatment period. It takes about 9 weeks to complete the study.
During each treatment period you will eat a cooked breakfast (you must eat everything); take 1 dose of either the study medicine or placebo; undergo 2 EEG sessions lasting 15 minutes each; undergo an MRI session lasting 1¼ hours; complete computer-based tasks and have blood samples taken.
Who are we looking to recruit?
You may be eligible for the study if you:
- are aged between 18 and 55
- are not currently taking medication for anxiety
- don’t smoke, vape, or use any other nicotine products
- are right-handed
- don’t have had any other mental health condition (except anxiety)
- are not pregnant (females only)
- can have an MRI scan.
Rewards and expenses
If you complete the study, you will receive £1100. We will reimburse reasonable travel expenses.
Are you interested in taking part in this study?
Conditions
AnxietyPeople types
Adult 18+Inclusion Criteria
To be eligible to participate in this trial, an individual must meet all the following criteria:
1. Males or females aged 18 to 55 years old (inclusive) at the date of signing the ICF.
2. Participants who are currently unmedicated (see exclusion criteria 18) and meet the criteria for GAD as defined in the DSM-5 by using the MINI.
3. Participants must be right-handed.
4. BMI between 18 and 30 kg/m2, inclusive, at Screening and a minimum weight of 50 kg.
5. Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
a. Male participants, with partners who are WOCBP must be either infertile (e.g., vasectomized, permanently sterile following bilateral orchidectomy, or any other documented cause of infertility) or sexually abstinent (note: abstinence is only acceptable if this is the usual lifestyle and preferred contraception for the participant) or agree to use a condom for the duration of the study and continue until 3 months after the last study visit. In this later case, their partners have to use in addition, a highly effective method of contraception starting one complete menstrual cycle prior to the first day of dosing and continue until 3 months after the participant’s last visit.
b. WOCBP with male partners must agree to use highly effective contraceptive methods starting one complete menstrual cycle prior to the first day of dosing and continuing until 3 months after their last visit. Their male partners must use in addition a condom, be infertile (e.g., vasectomized, permanently sterile following bilateral orchidectomy, or any other documented cause of infertility) or sexually abstinent (note: abstinence is only acceptable if this is the usual lifestyle and preferred contraception for the participant) for the duration of the study.
Female participants of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or postmenopausal, defined as the last period being more than 12 months ago without an alternative medical cause and confirmed by the FSH level in the postmenopausal range (for a woman not using hormonal contraception or hormonal replacement therapy) at Screening.
Highly effective methods of contraception are:
• Combined (i.e., estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
• Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
• Intrauterine hormone-releasing system.
• Intrauterine device.
• Bilateral tubal occlusion or ligation.
6. Participants must agree not to donate sperm or ova from the time of the first administration of study drug (T1, D2) until 3 months after the participant’s last visit.
7. Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the current version of the ICH GCP Guideline E6 and applicable regulations, before completing any study-related procedures.
8. Have an understanding, ability, and willingness to fully comply with study procedures as detailed in the Study Protocol and ICF.
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participating in this trial:
1. Current or past diseases (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematologic, neurologic, endocrine, immunologic, rheumatologic, dermatologic or other conditions) that may interfere with the execution of the conduct of the study, as per the Investigator’s judgement.
2. Participants with current or recurrent disease or treatment that can interfere with the absorption, metabolism, and elimination of SYT-510. Examples include participants with partial gastrostomy or impaired renal functions.
3. Participants with significant learning difficulties, uncorrected visual and auditory problems and history of dyslexia.
4. Participants with a current DSM-5 diagnosis of major depressive disorders or severe depressive symptoms determined by MADRS score > 20.
5. Substance use disorder within the past 6 months before Screening.
6. Any primary diagnosis other than GAD e.g., bipolar disorder, obsessive compulsive disorder, PTSD, psychotic disorder, cognitive impairment, or pervasive development disorder.
7. Any psychotic features, including dementia or delirium.
8. Experienced suicidal ideation with some intent to act within the 6 months preceding screening or any history of suicidal behaviour. Suicidal risk should be informed by clinical judgement, excluding participants who answer “Yes” on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Screening.
9. Other current or relevant history of physical, neurological or psychiatric illness that may require treatment (e.g., any history of epilepsy).
10. Participants with contraindications for MRI. Standard MRI contraindications in accordance with the current local procedures must be checked at the imaging facility: e.g., presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles).
11. Conditions that make the participant unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the study drug or study procedures.
12. Positive test for HBsAg, hepatitis C virus antibody, or human immunodeficiency virus antibody at Screening.
13. Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing on T1, D2 or presence of fever (confirmed body temperature > 38 ºC) within 14 days prior to dosing on T1, D2.
Diagnostic Assessments
14. Laboratory parameters outside of the laboratory normal range (haematology, biochemistry, coagulation, urinalysis), unless deemed NCS by the Investigator.
15. Has vital signs outside of the following normal range at Screening or Baseline, unless considered NCS by the Investigator: supine SBP 90–140 mmHg, supine DBP 50–90 mmHg, supine PR 40–100 bpm.
16. Has any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG or clinically important abnormalities that may interfere with the interpretation of QTc interval changes, or values outside of the normal range, unless considered NCS by the Investigator:
• PR 120–210 msec,
• QRS ≤ 120 msec,
• QTcB ≤ 430 msec for males and ≤ 450 msec for females, or
• Have signs of sinus node dysfunction.
17. Positive test results for alcohol or drugs of abuse at Screening or Baseline.
Prior/Concomitant Therapies
18. Has used any prescription medication (excluding hormonal therapy for postmenopausal women or contraception for WOCBP) within 30 days prior to Screening and any medication for the treatment of anxiety within 6 months prior to screening.
19. Consumption of herbal remedies or dietary supplements which may interact with the study drug (for example containing St. John’s Wort) in the 30 days prior to first dose and until the end of the study.
20. Use of cannabis, tetrahydrocannabinol or cannabidiol containing products in the 28 days before the Study T1, D2.
21. Participants who have received a live vaccine within 30 days prior to the first dose administration or who plan to receive a live vaccine during the study period.
Prior / Concurrent Clinical Study Experience
22. Treatment with an investigational drug within 90 days or 5 half-lives preceding the first dose of trial intervention (or as determined by the local requirement, whichever is the longer) or will start any other investigational product or device study within 90 days after last study drug administration.
Other Exclusion Criteria
23. Known or suspected intolerance or hypersensitivity to the investigational product, any closely related compound, or any of the stated ingredients.
24. History of significant allergic reactions (anaphylaxis, angioedema) to any product (food, pharmaceutical, etc.).
25. Donation of blood or blood products within 90 days, or plasma within 7 days prior to study drug administration on T1, D2.
26. Underwent general anaesthesia in the 30 days prior to study drug administration on T1, D2.
27. Nicotine consumption (in any form) equivalent to > 5 cigarettes or vapes per week.
28. Weekly intake of more than 14 units of alcohol.