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This study is being done to learn about the binding of Lu AG06466 and its major breakdown product (Lu AG06988) in the brain of healthy men having received multiple doses of Lu AG06466. As the binding will result in inhibition of an enzyme in the endocannabinoid system called monoacylglycerol lipase (MAGL), the effects on this system will be evaluated both in the blood and cerebrospinal fluid and compared to the binding in the brain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AG06466 Low Dose | Experimental | Participants will receive Lu AG06466 low dose capsule orally once daily for 6 days approximately 30 minutes following a light meal. |
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| Lu AG06466 High Dose | Experimental | Participants will receive Lu AG06466 high dose capsule orally once daily for 6 days approximately 30 minutes following a light meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG06466 | Drug | Lu AG06466 will be administered per dose and schedule specified in the arm description. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Lu AG06466 and Lu AG06988 | Day 5 (pre-dose, per hour before and after positron emission tomography [PET] imaging and per 30 minutes during PET imaging) and on Day 6 (3 hours post-dose) | |
| Cerebrospinal Fluid (CSF) Concentration of Lu AG06466 and Lu AG06988 | Pre-dose and on Day 6 (3 hours post-dose) | |
| Central MAGL Occupancy (%) Measured Using [18F]MNI-1188 PET Imaging | 2 to 4 hours post-dose on Day 5 | |
| CSF Concentrations of 2-arachidonolylglycerol (2-AG) (1-arachidonolylglycerol [1-AG]+2-AG), 2-oleoylglycerol (2-OG), and arachidonic acid (AA) | Day 6 (3 hours post-dose) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Invicro, LLC | New Haven | Connecticut | 06510 | United States |
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