Healthy
Conditions
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
Interventions
DRUGLu AG06466
capsules, orally
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central monoacylglycerol lipase (MAGL) occupancy | From dosing to 8 hours post-dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C(PET) | From zero to Day 10 | Average plasma concentration for Lu AG06466 and Lu AG06988 during PET imaging |
| 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 |
| Cmax | From zero to 24 hours post-dose | Maximum observed plasma concentration for Lu AG06466 and Lu AG06988 |
Countries
Belgium
Outcome results
None listed