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

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

Detailed Description
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lu AF88434
* Drug: [11C]-Lu AF88434


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AF88434<br> | Drug: Lu AF88434<br>* Oral solution<br>Drug: [11C]-Lu AF88434<br>* [11C]-Lu AF88434, and a radioactive dose not exceeding 400 MBq at each PET examination, intravenous bolus injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total distribution volume (VT) of [11C]-Lu AF88434 | Whole-brain distribution volume | At baseline and post-dose on Day 1 | 
| C(PET) of Lu AF88434 | Mean plasma concentration of Lu AF88434 during the post-dose PET measurement | Day 1 | 
| Area Under Curve (AUC(0-inf)) of Lu AF88434 | Area under the plasma concentration time curve of Lu AF88434 from zero to infinity | Day 1 | 
| Cmax of Lu AF88434 | Maximum observed plasma concentration of Lu AF88434 | Day 1 |