A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult Male Participants

Study Overview
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Brief Summary
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The main goals of the study are to assess uptake and distribution of Lu AF90103 in the brain when given at tracer levels (microdose) in healthy young men.

Official Title
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Interventional Open-Label Positron Emission Tomography Study Investigating Blood-Brain-Barrier Penetration and Pharmacokinetic Properties of [11C]-Lu AF90103 in Healthy Young Men

Conditions
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Healthy Young Men

Intervention / Treatment
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* Drug: [11C]-Lu AF90103


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participant has a body mass index (BMI) ≥18.5 and ≤30.0 kilograms (kg)/square meter (m^2) at the Screening Visit. The participant is, in the opinion of the investigator, generally healthy based on medical history; a physical examination; vital signs; an electrocardiogram (ECG); and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests. Exclusion Criteria: The participant has taken disallowed medication <1 week prior to the first dose of study drug or <5 half-lives prior to the Screening Visit for any medication taken. The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. The participant has had surgery or trauma with significant blood loss <3 months prior to the first dose of study drug. The participant is exposed to significant levels of ionizing radiation at work. Note: Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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: [11C]-Lu AF90103<br>Participants will receive [11C]-Lu AF90103 via an intravenous bolus injection on Day 1. | Drug: [11C]-Lu AF90103<br>* PET ligand administrated as a single intravenous bolus injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Time-Activity Curves for Brain up to 90 Minutes (AUCbrain 0-90 min) |  | Day 1 (predose and up to 90 minutes postdose) | 
| Area Under the Blood Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCblood 0-90 min) |  | Day 1 (predose and up to 90 minutes postdose) | 
| Area Under the Plasma Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCplasma 0-90 min) |  | Day 1 (predose and up to 90 minutes postdose) | 
| Whole Brain-to-Plasma Ratio Expressed by AUCbrain 0-90 min/AUCplasma 0-90 min |  | Day 1 (predose and up to 90 minutes postdose) | 
| Total Distribution Volume in the Whole Brain (VT brain) |  | Day 1 (predose and up to 90 minutes postdose) | 
| Ratio Between the Free Concentrations [11C]-Lu AF90103 in Brain Tissue and Plasma (Kp,uu) |  | Day 1 (predose and up to 90 minutes postdose) |