*Open-Label PET Study Investigating ENX-104
Research type
Research Study
Full title
An open-label positron emission tomography (PET) study to demonstrate safety, tolerability, receptor occupancy, and pharmacokinetics after a single oral dose administration of ENX-104 in healthy volunteers
IRAS ID
1010977
Contact name
Eve Taylor
Contact email
Sponsor organisation
Engrail Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
The trial is a single centre, open-label trial in up to 10 healthy, non-smoking males and females assigned at birth, inclusive of any gender identity between the ages of 23 and 65 years. \n\nThe medicine to be tested is this trial is a compound called ENX-104 being developed a new therapy for treating major depressive disorder and/or other disorders of the central nervous system (CNS).\n\nThe main purpose of the clinical trial is to see how safe the clinical trial medicine is and how well it is tolerated after dosing of the clinical trial medicine in healthy subjects and how it is absorbed in the brain. The clinical trial will also investigate how the clinical trial medicine is taken up and metabolised (chemically broken down). \nThe trial will comprise of:\n-\tScreening period of a maximum 45 days – Day -45 to Day -1\n-\tIn-house Treatment Period - Day -2 to Day 2 (admission on Day -2, Dosing on Day 1)\n-\tA Follow up Visit on Day 9
REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0813
Date of REC Opinion
13 Jan 2025
REC opinion
Further Information Favourable Opinion