Study Investigating Uptake and Distribution of Lu AF88434 in the Brain
Research type
Research Study
Full title
Interventional, open-label, positron emission tomography (PET) study with [11C]-Lu AF88434 investigating blood-brain barrier penetration, safety, and tolerability of Lu AF88434 in healthy men
IRAS ID
277126
Contact name
Oyeniyi Diya
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2019-002434-37
Duration of Study in the UK
0 years, 3 months, 9 days
Research summary
This is an interventional, open-label, positron emission tomography (PET, a brain scan) study in up to 8 healthy male subjects aged 20 to 55 years.
The main purpose of the study is to assess how the study drug goes into the brain and where it can be found in the brain after it has been taken, using an imaging technique called PET. For this purpose, a small amount of a radioactive version of the study drug (radiotracer) is given by injection into a vein (intravenously [IV]) in order to render the study drug visible in the brain during the brain scan. It will be assessed whether there are any changes in the brain distribution of the radiotracer before and after an oral dose of 2 mg Lu AF88434. It will also be investigated how much of the study drug is in the blood compared to the brain, how safe the study drug is, and why people may process it differently through genetic testing. Lu AF88434 is a novel compound being developed for the potential treatment of disordered thinking in disorders such as schizophenia.
The study comprises a screening period (2 visits: a Screening and an MRI scanning Visit), a Treatment Period (2 PET scans, safety monitoring and Completion Visit, all in-house) from Day-1 to Day 4, and a Follow-up Visit 7 days after dosing. For PET scan on Day 1 participants will be transferred to an imaging centre to undergo a baseline scan after receiving an injection of the radiotracer followed by the oral dose of Lu AF88434. Thereafter a further injection of radiotracer and a post-dosing PET scan will be performed. After imaging and dosing, participants will stay at the clinical unit for observation.
The study duration per participant will be approximately 9 days (5 weeks including screening period).
REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/0884
Date of REC Opinion
13 Jul 2020
REC opinion
Further Information Favourable Opinion