Binding of Lu AG06466 in the Brain in Healthy Men

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lu AG06466

Study type: Interventional

Funder types: Industry

Identifiers

NCT04419636

18454A

Details and patient eligibility

About

A study to learn how Lu AG06466 and one of its break down products binds in the brain after single and repeated dosing

Full 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

Enrollment: 16 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Part A Single doses

Experimental group

Description:

Lu AG06466 in fast and fed state

Treatment:

Drug: Lu AG06466

Part B Repeated doses

Experimental group

Description:

Lu AG06466 after light meal

Treatment:

Drug: Lu AG06466