*PET study with [11C]-Lu AF88370 investigating blood-brain barrier penetration of Lu AF88370
Research type
Research Study
Full title
Interventional, open-label, positron emission tomography (PET) study with [11C]-Lu AF88370 investigating blood-brain barrier penetration of Lu AF88370 in healthy men.
IRAS ID
1004767
Contact name
Armir Isufi
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2021-005082-40
Clinicaltrials.gov Identifier
Research summary
Research Summary
The Study Drug (Lu AF88370) is an investigational drug being developed by H. Lundbeck A/S with an aim to help people in the future with cognitive impairment (when a person has trouble remembering, learning new things, concentrating, or making decisions that affect their everyday life) associated with neurodegenerative disorders (a type of disease in which cells of the central nervous system stop working or die) and psychiatric disorders (a mental illness that affects mood, thinking, and behaviour).
Up to 6 participants will be enrolled in this Study.
The aims of this Study are to determine:
• The blood-brain barrier (a network of blood vessels and tissue that helps keep harmful substances from reaching the brain) penetration properties (the ability to get through the blood brain barrier, and therefore have an active effect) of the Study Drug when given as a radioactive tracer
• The brain distribution of the Study Drug when given as a radioactive tracer
• The safety of the Study Drug and any side effects that might be associated with it when given as a radioactive tracer
Participants will receive a single dose of the Study Drug on 1 dosing occasion as an intravenous infusion (via a tube linked to a small needle in their vein).
The Study Drug will contain carbon-11 (a naturally occurring radioactive form of carbon) to allow the Study Drug and its breakdown products to be measured in the blood. The reason for this is to allow different parts of the Study Drug to be traced in a brain positron emission tomography (PET) scan to provide an imaging test of participants’ brain and see where the Study Drug is binding.Summary of Results
Following confirmation within HLu, please be informed that a PLS (plain language summary) is expected to be prepared for all trials in patients only. Since, 19874A is not performed in patients or have been submitted under EU CTR PLS is not needed. in UK, for the studies completed from Sep 2021, the lay summary of results is only voluntary.
REC name
London - Harrow Research Ethics Committee
REC reference
22/FT/0021
Date of REC Opinion
11 Mar 2022
REC opinion
Further Information Favourable Opinion