Binding and Effects of Lu AG06466 in the Brain of Healthy Men
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
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.
Key facts
- Study ID
- NCT05219838
- Run by
- H. Lundbeck A/S
- People needed
- 8
- Starts
- 2022-01-18
- Expected to finish
- 2022-08-29
- Last updated by the study team
- 2022-09-09
Who can join
Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- The participant has a body mass index (BMI) ≥18 and ≤30 kilograms (kg)/square meter (m\^2) at the screening visit.
- The participant has a weight of ≥60 kg at the screening visit and baseline visit.
- The participant has a waist circumference ≤94 centimeters (cm) at the screening visit.
You may not qualify if…
- The participant has taken disallowed medication <2 weeks prior to the first dose of study drug or <5 half-lives prior to the screening visit for any medication taken.
- The participant has received a COVID-19 vaccination within the last 30 days before receiving first dose of study drug.
- The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
- Note: Other inclusion and exclusion criteria may apply.
Where it is running
- Invicro, LLC — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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