rBA/FE and MAD study of SYT-510 in healthy participants
Research type
Research Study
Full title
A Two-Part Study Investigating The Relative Bioavailability And The Potential Food Effect After A Single Oral Dose Administration Of A New Formulation of SYT-510, And The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Oral Dose Administration Of SYT-510 in Healthy Subjects
IRAS ID
1010456
Contact name
Andrea Chicca
Contact email
Sponsor organisation
Synendos Theraputics AG
Clinicaltrials.gov Identifier
Research summary
SYT-510 is a selective endocannabinoid reuptake inhibitor, intended to increase levels of endocannabinoids in the central nervous system (CNS). It is intended as a potential treatment for CNS disorders, such as Tourette syndrome and post-traumatic stress disorder, which are characterised by altered endocannabinoid levels and have a high unmet medical need.
An ongoing study of SYT-510 is using a flavoured emulsion. The intention is to replace the flavoured formulation with a powder for suspension for further investigations. Part 1 of the current study will enrol up to 18 healthy participants to assess how the powder formulation is absorbed by the body, with and without food, compared to the flavoured emulsion. All participants will receive each of the formulations, in a randomly assigned sequence, separated by 14-day washout periods.
This will then guide dosing in Part 2, a multiple dose study enrolling up to 12 healthy participants per cohort using the flavoured emulsion or powder for suspension formulation. It will investigate the safety and tolerability of SYT-510 and the way it is processed in the body. Participants will have a 3:1 chance of receiving daily doses of either SYT-510 or placebo for 14 days, during a 22 day in-unit admission. Cerebrospinal fluid (CSF) sampling will be performed by an experienced consultant prior to dosing, and at specified points post dosing to assess the levels of endocannabinoids and other biomarkers in the fluid around the brain and spinal cord. Part 2 is a double-blinded study, whereby neither the study doctor nor the participants know which treatment they receive, and the treatments will be randomly assigned.
SYT-510 has so far shown a favourable safety profile based on an ongoing single dose study and the pre-clinical data. Prior to enrolment, participants for Part 1 and Part 2 will be assessed to ensure they are safe to dose and will be closely monitored throughout the study.
REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0524
Date of REC Opinion
7 Oct 2024
REC opinion
Further Information Favourable Opinion