A Study in Healthy Men to Investigate Uptake and Distribution of Lu AF88434 in the Brain

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

This study will investigate how much of Lu AF88434 will get into the blood and the brain in healthy men

The study consists of the following parts:

• a Screening Visit
• an MRI scanning visit
• an in-clinic stay which includes: a Safety Baseline one day prior to dosing, a one-day [11C]-Lu AF88434 imaging session consisting of a baseline PET measurement and a post-dose PET measurement conducted after the administration of a single oral dose of Lu AF88434, pharmacokinetic (PK) sampling and safety assessments throughout the period
• a Follow-up Visit 7 days after dosing

Inclusion Criteria:

• The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit
• The subject has a normal MRI performed during the screening period, as judged by the investigator
• The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests
• The subject can tolerate confined spaces for prolonged periods of time
• The subject is suitable for radial artery blood sampling and cannulation

Exclusion Criteria:

• The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the Investigational Medicinal Product (IMP)

Other in- or exclusion criteria may apply