Binding of Lu AG06466 in the Brain in Healthy Men
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Lu AG06466
- Registration Number
- NCT04419636
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
A study to learn how Lu AG06466 and one of its break down products binds in the brain after single and repeated dosing
- Detailed Description
The study will be conducted in two Parts. Part A: cross over, fed/fasted determined by randomized sequence Part B: sequential group
PET scans will be used to quantify MAGL occupancy
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
- body weight ≥60 kg.
- body mass index ≥18.5 and ≤27 kg/m2.
- waist circumference ≤94 cm.
- The subject has a normal sMRI performed during the screening period.
- The subject is suitable for radial artery blood sampling and cannulation as demonstrated by the Allen test.
- Subject must be healthy as assessed using detailed medical history, laboratory tests, and physical examination.
- The subject must make use of contraception.
Exclusion Criteria
- The subject is left handed.
Other in- and exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A Single doses Lu AG06466 Lu AG06466 in fast and fed state Part B Repeated doses Lu AG06466 Lu AG06466 after light meal
- Primary Outcome Measures
Name Time Method Central monoacylglycerol lipase (MAGL) occupancy From dosing to 8 hours post-dose
- Secondary Outcome Measures
Name Time Method C(PET) From zero to Day 10 Average plasma concentration for Lu AG06466 and Lu AG06988 during PET imaging
Cmax From zero to 24 hours post-dose Maximum observed plasma concentration for Lu AG06466 and Lu AG06988
AUC (0-24) From zero to 24 hours post-dose Area under the plasma concentration curve for Lu AG06466 and Lu AG06988 from zero to 24 hours
Trial Locations
- Locations (1)
UZ Leuven campus Gasthuisberg
🇧🇪Leuven, Belgium