NCT05219838

Binding and Effects of Lu AG06466 in the Brain of Healthy Men

Interventional , Open-label, Positron Emission Tomography (PET) Study With [18F]-T-401 Investigating MAGL Enzyme Occupancy After Multiple Oral Doses of Lu AG06466

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Lu AG06466	Lu AG06466 will be administered per dose and schedule specified in the arm description.

Timeline

• Start date: 2022-01-18
• Primary completion: 2022-08-18
• Completion: 2022-08-29
• First posted: 2022-02-02
• Last updated: 2022-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study