Status:
COMPLETED
Binding of Lu AG06466 in the Brain in Healthy Men
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- The subject is left handed.
- Other in- and exclusion criteria may apply
Key Trial Info
Start Date :
May 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04419636
Start Date
May 29 2020
End Date
February 16 2021
Last Update
February 24 2021
Active Locations (1)
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1
UZ Leuven campus Gasthuisberg
Leuven, Belgium, 3000