*Safety, Tolerability and Brain Imaging Study of Lu AG12947 in Healthy Men and Women
Research type
Research Study
Full title
Interventional, randomized, double-blind, sequential cohort, placebo-controlled, multiple-dose trial investigating the safety, tolerability, and pharmacokinetic and pharmacodynamic properties of Lu AG12947 in healthy men and women, with an open-label, positron emission tomography (PET) part with 18F MNI 1188 investigating monoacylglycerol lipase (MAGL) enzyme occupancy in men and women
IRAS ID
1011008
Contact name
Jette Buch Østergaard
Contact email
Sponsor organisation
H. Lundbeck A/S
Research summary
Lu AG12947 is a new medicine being developed by Lundbeck to help people with disorders in the brain like epilepsy, which causes seizures. The researchers think it could help the brain work better by boosting its natural protective systems. It can enter brain and works by blocking a specific protein called monoacylglycerol lipase (MAGL), interfering with the normal functioning of nervous system.
This is a randomised, placebo-controlled trial which means the participants will be assigned to receive oral doses of either Lu AG12947 or matching placebo once daily completely by chance. This trial includes three parts: Part A, Part B and Part C based upon varying objectives, occurring one after the other. Part A and Part B are double- blinded which means both trial doctor and participants will not know which trial medicine the participant is receiving while Part C is open-label where both trial doctor and participants will know the medicine the participants receive. This is a second clinical trial with Lu AG12947 including healthy participants aged between 18 to 55 years.
The main goal of this trial is to see how safe and well-tolerated Lu AG12947 is when given multiple times. Researchers also want to understand how the drug moves through and is processed by the body (Part A and Part B).
Another purpose is to check if the trial medicine is getting to the right places in the brain. It will be tested by using a special type of brain scan called positron-emission tomography (PET) imaging that uses radiation and measures the amount of protein (in this case MAGL) in the brain (Part C). This will help to see if the trial medicine is attaching to MAGL in the brain.
In earlier non-clinical and first in human trials, no safety concerns have been identified with Lu AG12947, therefore, there is minimal overall risk to participants.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0334
Date of REC Opinion
28 Jan 2025
REC opinion
Further Information Favourable Opinion